Date Published: 2021-03-31

Is R&D Committee approval required for all types of expanded access protocols or uses of investigational medical products, to include single patient, intermediate population, and treatment protocols?

No. R&D Committee approval is not required for any emergency use of an investigational medical product (drug, biologic, or medical device) as described in FDA’s expanded access regulations in 21 CFR §56.104. However, R&D Committee prospective approval is required for any non emergency use of investigational medical products under FDA’s regulations. VA adheres to FDA’s expanded access regulations, which includes the different categories of single patient, intermediate-size population, and wide-spread treatment protocols or uses for investigational drugs and biologics. FDA’s expanded access categories for unapproved medical devices are emergency use, compassionate (for single patient or intermediate-size population), and wide-spread treatment protocols or uses.

The R&D Committee can choose to use a designated review process as described in VHA Directive 1200.01, Paragraph 9e(5) to provide initial approval for all non-emergency expanded access protocols or uses involving investigational medical products following approval by the IRB. Emergency use of an investigational medical product under FDA’s expanded access regulations do not require R&D Committee approval.

Date Published: 2021-03-31

When will use of the Enterprise Research Data Security Plan (ERDSP) be required?

The Enterprise Research Data Security Plan is currently undergoing field testing. The soft pilot and testing of the tool is currently aligned with the implementation of the VA Innovation and Research Review System (VAIRRS) platform.

ERDSP will be required at the Phase 4 of the ERDSP Implementation Plan when it is in full operational capability on May 10, 2021. Approximately 30 research facilities participated in an initial ERDSP soft pilot release from March 22, 2021 to April 19, 2021, to support the IRB/Research & Development (R&D) Committee study/protocol review processes and procedures within VAIRRS. Below is the implementation plan for the ERDSP rollout:

• Phase 1: Pilot & Soft Launch - 30 VA research facilities will begin using the new ERDSP toolset to support the IRB/R&D committee protocol review processes and procedures (3/22/21 – 4/19/21)
• Phase 2: Collect and incorporate feedback (4/19/21 – 4/26/21)
• Phase 3: Training to the field (4/26/21 – 5/7/21)
• Phase 4: Full Operational Capability (5/10/21)

⎯ VA Research Principal Investigators are required to submit an ERDSP for each human, animal, and basic laboratory protocol/amendment submission detailing the proposed study's/protocol’s plan for implementing reasonable safeguards to protect research data.

Date Published: 2021-03-31

Is ISSO review required for all VA research?

ISSO review is required for all VA research involving human subjects, to include research that is exempt from the Common Rule.

(a) If the proposed new/amended research protocol meets any of the high-risk conditions, sections selected for an amendment, or certain questions are answered within the ERDSP template, then an ISSO review maybe required:
e.g. High Risk Conditions:
⎯ Will any VA Sensitive Information (VASI) be accessed, stored, generated or transmitted during the research study?
⎯ Will the research study use any VA Mobile Devices or Mobile Applications?
⎯ Will any research study/protocol data be transmitted or transferred to an external entity?
⎯ Will the research study use any external information systems or devices?

(b) If the Research protocol amendment changes any of the ERDSP questions related to the research study conditions, an ISSO review is required. The ERDSP will display an “ISSO Review Required” banner above the PI signature block if an ISSO review is required.

Best Practice: The ISSO should review the proposed research study protocol and verify the information contained in the ERDSP is correct. At a minimum, the ISSO will review the following documents:
• ERDSP
• Protocol
• Informed Consent Application
• HIPAA authorization
• IRB Application
• Local site developed forms that may contain information relevant to the security of the research study data.

NOTE: All VA human subjects’ studies (including exempt research) must continue to have an ISSO and PO review prior to the study receiving final R&D Committee approval, and such reviews must be documented. This requirement will continue to be enforced by ORO.

For more information, locate the ERDSP Toolset and supporting User Guide within the following web portals:
i. ORD Toolkit: Research Information Security & Cybersecurity
ii. OIS Research Support Division Public Documents

Date Published: 2021-03-31

Is the R&D Committee required to convene a R&D Committee meeting to review all new (initial) studies for approval?

No. ORD policy in VHA Directive 1200.01, Paragraph 9.e allows the following new (initial) studies to be approved by the R&D Committee using a designated review process with no convened R&D Committee requirement:

a. Exempt human subject research protocols
b. Protocols approved by expedited review by the IRB.
c. Non-emergency expanded access protocols or activities approved by the IRB. Note: Emergency expanded access protocols or activities do not require prospective R&D Committee approval or notification.
d. Protocols that do not involve human subjects, biosafety level (BSL-3) or higher containment, use of select agents or non-exempt quantities of select toxins, United States Department of Agriculture (USDA)-regulated animal species, or any animal research involving more than momentary pain or distress to animals.

Date Published: 2021-03-31

Does the VHA Office of Research and Development require the use of Material Transfer Agreements (MTAs) for sharing or transferring of VA biospecimens?

No. ORD policy requiring the use of MTAs applies to collaborative research activities. VHA Directive 1200.01 paragraph 10c requires the use of an MTA when transferring biospecimens from VA as part of collaborative research, unless the biospecimens’ transfer is addressed in another agreement executed between VA and the collaborating institution or party. Alternative agreements include CRADAs, subawards, MOUs, or other appropriate agreements. ORD Technology Transfer has published a VA MTA template that can be found on the Technology Transfer webpage: https://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm.

While ORD does not require use of the VA MTA template, its use is encouraged because it simplifies the review process, particularly when VA is the provider.

Date Published: 2021-03-31

What should the R&D Committee review for exempt research?

The R&D Committee may establish a research review sub-committee for exempt research or serve as the research review committee itself. This committee or subcommittee must conduct initial review, review of amendments or other changes to the research, and review of reportable events. Exempt research requiring limited IRB review is not under the continuing oversight of the IRB. The exempt research should be reviewed according to the review criteria established by local policy in accordance with VHA Directive 1200.01. In accordance with VHA Directive 1200.01 paragraph 9d(2)(c), exempt research does not require continuing review; however local policy may require that status updates be submitted for review at pre-determined intervals.

Date Published: 2021-03-18

Is DocuSign’s electronic signature compliant with 21 CFR 11?

Not all Docusign envelopes are compliant with 21 CFR 11 (aka Part 11 compliant). Only Docusign envelopes that include the Part 11 compliance module are compliant with the FDA regulations at 21 CFR 11. ORD has purchased both types of envelopes from Docusign under the IAM contract (i.e. 21 CFR 11 compliant envelopes and envelopes that are not compliant with 21 CFR 11). When submitting requests for Docusign envelopes to ORD, you will be asked to indicate whether your study is FDA-regulated (i.e., involves drugs, supplements or medical devices). If approved, studies that are FDA-regulated will be issued Docusign envelopes that are compliant with 21 CFR 11.

Requests for Docusign envelopes can be submitted via ORD’s SharePoint site located here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign

Date Published: 2021-03-12

Does ORD policy require that all research protocols are reviewed by a Subcommittee on Research Safety and Security (SRSS aka SRS)?

No. ORD policy does not require that all research studies be reviewed by an SRSS/SRS. The types of studies requiring review by an SRSS/SRS was revised in VHA Directive 1200.08: Safety of Personnel and Security of Laboratories Involved in VA Research (April 24, 2019 and amended January 8, 2021). Paragraph 1 states that the Directive applies to all VA research conducted in VA research laboratories. ORD revised VHA Directive 1200.08 with the purposeful intent that it only applies to research involving VA research laboratories. ORD’s intent as part of the revision of VHA Directive 1200.08 was to exclude SRSS review as a requirement for research activities conducted in the clinical settings. While a VA Facility can choose to require SRSS/SRS review for those research activities involving biohazards conducted in clinical settings, ORD policy in the referenced VHA Directive 1200.08 requires SRSS/SRS review when the research activity involves hazards for activities conducted by or in the VA research laboratory.

Date Published: 2020-12-30

How do VA Investigators request use of DocuSign for its use to obtain informed consent in a VA study?

The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign. Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided. IRB approval must be obtained prior to use of DocuSign for a specific study.

Date Published: 2020-12-30

Can any VA study use DocuSign to obtain electronic informed consent and/or HIPAA Authorization?

ORD has purchased a supply of envelopes to be used in research studies requiring documentation of informed consent and/or HIPAA Authorization. All requests are considered but studies requiring the creation of <100 envelopes (100 subjects) will need to provide justification due to the support required by the OI&T Identity and Access management Team. Inpatient studies are generally not appropriate for DocuSign and study teams should consider the use of iMedConsentTM for inpatient studies or studies where all study subjects will present to a facility with CPRS access. faq_imedconsent_asynchronous_signature_121714.pdf (va.gov).

For studies funded by sponsors outside of VA, please make sure that your sponsor will not require the use of their electronic signature platform prior to requesting DocuSign use. Reimbursement to ORD may be required for studies funded by non-VA sponsors (process under consideration).

The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign. Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided. IRB approval must be obtained prior to use of DocuSign for a specific study.

Date Published: 2020-12-30

Can VA Facilities or VA Nonprofit Corporations enter into their own contracts for use of DocuSign to obtain electronic informed consent for VA studies conducted at their VA Facilities?

No. The VA national DocuSign contract is managed by the VA Identity and Access Management (IAM) Program. VA’s use of DocuSign occurs through the Gov Cloud Authority to Operate (ATO) that IAM has established. The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign

Date Published: 2020-12-30

Is DocuSign’s electronic signature compliant with all VA privacy requirements?

Yes. VA Identity and Security Services, VA OIT Enterprise Program Management Office offers an e-Signature Service that complies with security, privacy and the ESign Act requirements. The product authorized by VA for authenticated e-Signature is Adobe DocuSign. The contract with DocuSign is at the Department and all security (e.g., ATO) and privacy (e.g., PTA/PIA) documents are completed at the national level. VHA facility Privacy Officers should not be completing such documents or contacting DocuSign for such information to determine the security and privacy compliance of the software. Rita Grewal is the VA Privacy Officer for DocuSign.

The only requirement for the VHA facility Privacy Officer to confirm before approval is that the facility-specific VA form for DocuSign matches the template without alteration other than overprinting or as permitted by the template itself and full SSN is not being requested on the form.

Date Published: 2020-12-30

Can DocuSign be used for obtaining informed consent in VA research?

Yes. DocuSign is a VA OI&T approved secure method for electronically transmitting informed consent forms (electronic consent) and obtaining wet, electronic, or digital signatures from VA participants or a VA participant’s legally authorized representative (LAR). IRB approval must be obtained prior to use of DocuSign for a specific VA study.

The process to request the use of DocuSign is to complete the form at the ORD SharePoint site located here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign. Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided.

Post approval instructions, SOPs, and training materials can be found here: https://dvagov.sharepoint.com/sites/VHAORPPE/DocuSign/SitePages/Post-Approval-Instructions.aspx

Date Published: 2020-09-24

Are all VA employees eligible to participate in all VA conducted COVID-19 studies?

All employees are eligible subject to the following exceptions:

a. The employee does not meet the study specific, IRB-approved criteria.
b. Possible challenges regarding off duty recruitment and enrollment.

Date Published: 2020-09-24

Can an employee participate in COVID-19 research studies during his/her duty day?

No. If an employee is interested in participating, he/she may contact the study team and learn whether the study is accepting employee recruitment before and after duty hours and on breaks. An employee may also participate while on approved leave. No change in the conditions of employment may be made for participation in the study.

Date Published: 2020-09-24

Can VA Medical Center leadership or supervisors encourage their employees to participate in VA research studies?

No. To avoid the appearance of undue influence over any employee, Medical Center leadership and supervisors will not encourage employees to participate in any research study. Supervisors are not to track or inquire about the enrollment of employees in any research study. Conditions of employment will not be changed for any employee who volunteers or does not volunteer for a COVID-19 study based on such a decision. No VA employees can take time away from their duty day to engage in study activities. Employees are welcome to take annual leave to participate in study activities that would otherwise interfere with the performance of duty.

Date Published: 2020-09-24

Can VA Medical Center leadership and supervisors volunteer to participate in COVID-19 studies?

Yes. Any employee may volunteer during off-duty time or on leave. Medical Center leaders and supervisors must be careful not to encourage or promote participation to avoid any perception of undue influence. If Medical Center leaders decide to join a study, their participation should not be used as a promotion for study recruitment though it can be stated that leaders have chosen to volunteer as to not give the impression that the study is too risky in which to participate.

Date Published: 2020-09-24

Can contractors participate in COVID-19 research studies?

No. Contractors are not considered VA employees. A VA employee is any individual who is employed by VA, including one who is salaried by VA or is working under a VA Without-Compensation Appointment (38 U.S.C. § 513, 38 U.S.C. § 7405(a)(1), and 38 U.S.C. § 7406) or under an Intergovernmental Personnel Act assignment (5 U.S.C. §§ 3371-75).

Date Published: 2020-09-24

For employees participating in COVID-19 research studies, are there additional requirements for the research study team if a potential subject does not have a VHA medical record?

Yes. If the study involves a clinical visit, coordination with the VHA medical center medical services office is required to create a medical record in CPRS/CERNER. Study records can only be created by trained personnel. Coordination for support from medical services should be made by the study team prior to the start of study recruitment. Medical Services can train additional staff to augment the study teams during peak enrollment. All participants having a medical record created must also be given a copy (hardcopy or electronic) of the VHA Notice of Privacy Practices. Notice of Privacy Practices

Date Published: 2020-09-24

If getting the flu shot is required for a position, but the flu shot will interfere with study participation, may an employee miss a required vaccination with the flu shot?

No. There can be no changes in conditions of employment as a result of participation in the research study. All employees who are expected to receive the flu shot by a certain date must have the flu shot by that date. If participation in the study will interfere with that schedule, then the flu shot, or any other employment related examination or treatment, takes precedence.

Date Published: 2020-09-24

If an employee takes part in a COVID-19 vaccination trial, will there have to be any changes in Personnel Protective Equipment or social distancing requirements?

No. There is no intention for an employee to be unnecessarily exposed to the SARS CoV-2 virus as part of these studies. Every precaution that employees have been taking should be continued throughout the study until medical center/VHA guidance is changed for everyone.

Date Published: 2020-09-24

If an employee gets sick/harmed from being in a COVID-19 trial and misses work, will the employee be charged leave?

Yes. Any time off work will be subject to standard leave policies. Supervisors will not be aware of who is participating in the research trials unless the employee discloses that information.

Date Published: 2020-09-24

If a VA employee who is asymptomatic and, in being screened for a research study, is found to have the SARS-CoV-2 virus, what happens?

The study team is required to report all positive cases to the VHA medical center leadership and/or local public health authority and follow local VHA policy. The OPM published guidance, “Federal Employee Coverage under the Leave Provisions of the Families First Coronavirus Response Act (FFCRA)” will apply. FFCRA.pdf

Date Published: 2020-09-24

If an employee is injured in a COVID-19 study as a result of a countermeasure (vaccine or other therapeutic) and suffers from lost wages, what can the employee do?

The DHHS Health Resources & Services Administration has established the Countermeasures Injury Compensation Program (CICP). An injured or harmed study subject may apply for benefits through this program. CICP

Date Published: 2020-09-24

If a VA employee wants to participate in a COVID-19 research study and his/her VHA facility is not offering the trial, can the employee participate in a trial through an affiliate or other research organization?

Yes. Employment by the VA is not prohibitive for volunteering for research conducted outside of the VHA. All COVID-19 clinical trials can be found at clinicaltrials.gov . To register with the COVID-19 Prevention Network to find a vaccine trial outside of VHA, visit: CoVPN Registry.

Date Published: 2020-09-16

What process do you use in IRBNet for managing financial Conflict of Interest review? We currently collect FCOI forms (outside the system) from investigators (PI, co-I) for each study at initial study submission, continuing review, or if there is a change in their information. We're not sure the best way to document/track in IRBNet that COI forms are on file and have been reviewed.

The COI review findings may be documented using the sample letter template available for download from the toolkit on the VAIRRS SharePoint portal. ​

Date Published: 2020-09-16

Is there a flow chart of the VAIRRS submission process that can be shared with the IRB, RDC, Safety, IBC, IACUC committee members and Researchers?

Yes. A high-level flowchart of the intended submission process is available for download from the toolkit on the VAIRRS SharePoint portal. ​

Date Published: 2020-09-16

Where can newly transitioned sites go for more help once training is complete?

A number of resources are available for newly transitioned sites. The VAIRRS ‘Ask the Mentor’ Discussion Board on the VAIRRS SharePoint portal is a great resource for questions not answered by the FAQs. You may also request a one-on-one mentor by emailing the project team at VAIRRS@VA.gov.

Date Published: 2020-09-16

Are sites required to use the ORPP&E core library?

The Project Cover Sheet is required for all submissions. The IRB Information Sheet is required for all submissions to the IRB (internal and external). The ORPP&E core library was designed to provide a standard set of forms and letters for all sites. However, IRBNet supports the ability for you to upload your own supplemental forms (such as if a particular form or template is required to support state or local regulations) via the Library Manager.

Date Published: 2020-08-17

Does the PREP Act apply to all VHA COVID-19 research involving a covered COVID-19 countermeasure?

Yes. This provision applies to all VHA COVID-19 research involving a covered countermeasure begun on/after February 4, 2020 through October 1, 2024 (unless amended).

Date Published: 2020-08-17

What is a covered COVID-19 countermeasure?

A covered COVID-19 countermeasure includes: an antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine used to treat, diagnose, cure, prevent, or mitigate COVID–19, or the transmission of SARS-CoV–2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. (§ 247d-6d(i)(1)(A)).

Date Published: 2020-08-17

Who are the “covered persons” referenced in the PREP Act?

As it applies to VHA, all VHA employees involved in the distribution, application and/or administration of the COVID-19 countermeasure are included in the definition of covered person for the sake of this declaration. As defined in the HHS declaration, “covered persons” include, “the United States as well as manufacturers, distributors, prescribers, administrators, and dispensers of such countermeasures, including agents and employees. ”

Date Published: 2020-08-17

What liability protections are available for “covered persons” in the PREP Act?

“Covered persons” are immune from lawsuits and liability under federal and state law with respect to all claims for loss except for death or serious physical injury proximately caused by willful misconduct. § 247d-6d(d)

Date Published: 2020-08-17

What types of loss/harm to study subjects are covered by the Prep Act?

Any conceivable loss that a research subject would incur is covered by the PREP Act. The loss described by the statute includes death, physical, mental or emotional injury, illness and a host of related injuries as well as property damage or loss. § 247d-6d(a)(2)(A).

Date Published: 2020-08-17

If a study subject suffers a loss as a result of participation in a COVID-19 trial involving a countermeasure, does he/she have any recourse for care?

Yes. VA medical facilities, including joint VA-DoD Federal health care centers, must provide necessary medical treatment (i.e., not just emergency treatment) to a research subject injured as a result of participation in a research study approved by a VA R&D Committee and conducted under the supervision of one or more VA employees. Regardless of Veteran status, a research subject participating in R&DC approved research studies will be treated for his/her injury at no cost for the care. (38 CFR 17.85 and VHA Directive 1200.05 para 24). This care may be provided by the local VA medical facility or arrangements may be made for contracted care at another facility.

Date Published: 2020-08-17

If a study subject suffers a loss as a result of participation in a COVID-19 trial involving a countermeasure, can the study subject file a federal tort claim against VA and recover damages?

No. Typically, the liability, if any of the United States for damage to or loss of property, or personal injury or death is governed exclusively by the provisions of the Federal Tort Claims Act (FTCA). However, the PREP Act supersedes the FTCA. Thus, any claim under the FTCA by VA subjects involved in COVID-19 research with COVID countermeasures would likely be barred. The study subject can seek benefits through the DHHS Health Resources & Services Administration Countermeasures Injury Compensation Program (CICP). https://www.hrsa.gov/cicp/index.html

Date Published: 2020-08-17

Can a subject in a COVID-19 study involving a covered COVID-19 countermeasure sue a covered person other than VA for damages for injuries or harm under State law?

No. The statute includes a provision expressly pre-empting states from enforcing laws that are in conflict with requirements of the Act (42 USCS § 247d-6d(b)(8), but does allow application of state law in the willful misconduct provision as in FTCA cases. § 247d- 6d(e)(2).

Date Published: 2020-08-17

Is the research informed consent form of a COVID-19 countermeasure study required to contain information regarding the PREP Act?

It depends on when the study was approved with relation to this guidance. The Prep Act applies whether or not the language is in the consent form. ORD believes that it could be reasonable to conclude that a reasonable person may want to know of their limited ability to sue if he/she suffers a loss or is injured or harmed, as a result of participating in a COVID-19 countermeasure study; correspondingly, it could be reasonable to conclude that such information is information that a reasonable person would want to have in order to make an informed decision about whether to participate in such research per 38 CFR §16.116(a)(4). As such, ORD is requiring that research informed consent forms for a VA COVID-19 countermeasure study approved after issuance of this guidance must contain the language in FAQ# 11 below. However, research informed consent forms for a VA COVID-19 countermeasure study approved prior to issuance of this guidance are not required to contain information about the PREP Act; nevertheless, ORD encourages that the consent forms for those studies be modified to include the language.

Date Published: 2020-08-17

Does the PREP Act information need to be part of the “Key Information” at the front of the consent form?

No. The PREP Act information may be placed where other liability language is noted in the consent form.

Date Published: 2020-08-17

What is the language that has been approved by ORD and OGC to be included in the informed consent form of studies to which the PREP Act applies?

The following language is to be used:

A new public health law under the Public Readiness and Emergency Preparedness Act (PREP Act) was issued by the Department of Health and Human Services on March 10, 2020. This law limits your ability to sue if you are in a COVID-19 research study. If this study uses a drug, device or vaccine designed to treat, diagnose, cure or prevent COVID- 19, you cannot sue the manufacturers, the study sponsor, healthcare providers or other professionals involved in the study for injury or harm (i.e., getting hurt) unless the injury or harm was on purpose. You may be compensated for injury or harm through a Department of Health and Human Services program called the Countermeasures Injury Compensation Program (CICP). For more information about this program, please contact the Health Resources and Services Administration’s CICP by phone at 855-266-2427 or online at https://www.hrsa.gov/cicp/about/index.html.

VA will provide necessary medical treatment should you be injured by being in this study. You will be treated for the injury at no cost to you. This care may be provided by the local VAMC or arrangements may be made for contracted care at another facility. In case of research related injury resulting from this study, you should contact your study team. If you have questions about medical treatment for any study related injuries, you can call the operator at this VA Medical Center and ask for medical administration.

You still have the right to hold VA responsible for negligence that is not related to a COVID- 19 research study.

Date Published: 2020-08-17

Can the approved VA PREP Act consent form language be modified by the IRB?

No. OGC has provided this language and it can only be altered with their prospective concurrence.

Date Published: 2020-08-17

If a commercial IRB is serving as the reviewing IRB for a COVID-19 study involving covered COVID-19 countermeasures, who is responsible to provide the VA approved PREP Act language?

ORD provided the OGC approved PREP Act language to the current ORD-approved commercial IRBs (i.e., WIRB and Advarra). Investigators are required to ensure that the language is not altered by the commercial IRB personnel. If any new commercial IRBs are approved by ORD and serve as a reviewing IRB for a COVID-19 study involving COVID-19 countermeasures, ORD will provide the required consent form language to that IRB as well.

Date Published: 2020-08-17

Does the PREP Act impact VA’s Cooperative Research and Development Agreements (CRADAs)?

Yes, since most of VA’s CRADAs contain a section covering the indemnification and liability of the collaborator for costs associated with a subject’s injury, and VA’s liability, the PREP Act will impact CRADA language. Contact OGC’s Health Care Law Group STAR. If unsure of STAR attorney assigned to the VA medical facility, click here.

Date Published: 2020-08-17

Does the PREP Act impact other non-CRADA agreements regarding COVID-19 studies using covered COVID-19 countermeasures (e.g., DOD is the sponsor)?

Yes, since other agreements tend to include indemnification and liability provisions. Contact OGC’s Health Care Law Group STAR. If unsure of STAR attorney assigned to the VA medical facility, click here.

Date Published: 2020-08-17

Our agreements (e.g., CRADAs, grant agreements, subcontracts) do not mention or use the terminology of covered COVID-19 countermeasures, so how does this apply?

VA agreement language refers to these covered COVID-19 countermeasures as test articles (drugs or devices) used in COVID-19 research. The language in the agreement may be changed from test article to specifically highlight covered COVID-19 countermeasures as determined by OGC.

Date Published: 2020-08-17

Is the R&D Committee required to approve the enrollment of non-Veterans participating in COVID-19 research studies involving a covered COVID-19 countermeasure?

Yes. The R&D Committee must review the justification and provide specific approval for recruitment of non-Veterans in VA approved research as required by VHA Directive 1200.01, Paragraph 13.a. The R&D Committee should evaluate who will be responsible for paying for any study-related costs and medical care or treatment for non-Veterans included in research activities involving VA hospital inpatient or outpatient treatment. The Prep Act does not currently provide funding for payment of research-related injuries.

Date Published: 2020-07-10

Does my VA Facility have to obtain separate approval from ORD to use iMED consent for research since it is required in VHA Handbook 1004.01: Informed Consent for Clinical Treatments and Procedures?

No. When ORD worked with the National Center for Ethics in Health Care to nationally deploy the Mayo Clinic Expanded Access Program informed consent document across all VA Facilities using iMED, it was an approval by ORD for VA Facilities to use iMED consent for research. Please note that all research informed consent forms will not be nationally deployed using iMED; most research studies do not involve large number of VA Facilities and would result in thousands of iMED consents deployed nationally that are not applicable to a VA Facility. Research studies involving one or small number of VA sites are entered locally by the VA Facility’s iMED consent coordinator.

In addition, an amendment was issued to VHA 1004.01 which removes the prior requirement to obtain ORD approval to use iMED consent for research.

Date Published: 2020-06-30

Is completion of a VA Form 10-250, VHA Research Protocol Privacy Review Checklist, required for all VA research?

No. VHA Directive 1605.03, Appendix A, Paragraph k.(1) requires VHA Privacy Officers to conduct a privacy review of all VA human subject research protocols. Completion of the applicable sections of VA Form 10-250 is required for all VA research involving human subjects or data from humans, including exempt research and research involving de-identified data from humans. Basic laboratory research not involving data from humans and animal research does not require completion of a VA Form 10-250. ORO has agreed to exercise enforcement discretion of the policy requirement in VHA Directive 1200.01 requiring Privacy Officer review of all VA research.

As noted in the current exception under review by ORD, “Memorandum from the DEAN-DUSH: Delay in Implementation of VHA Directive 1200.01”, ORO will continue to exercise its enforcement discretion of the following policy requirement until July 31, 2020:

Paragraphs 5.h.(6), 5.j, and 5.k – Completion of Information System Security Officer (ISSO) and Privacy Officer (PO) review before any VA study is given final approval. ORD is working with the Office of Information Security and VHA Privacy to resolve issues and revise policy language. NOTE: All VA human subjects’ studies (including exempt research) must continue to have an ISSO and PO review prior to the study receiving final R&D Committee approval, and such reviews must be documented. This requirement will continue to be enforced by ORO.

Date Published: 2020-06-22

Does the ORD COVID-19 administrative hold apply to my study?

Yes, if your study is ORD funded (by BLRD, CSRD, HSRD, RRD, QUERI, CSP or MVP) and involves non-critical in-person interactions or interventions with human subjects as defined in the ORD Administrative Hold memorandum and below. If your ORD funded study involves non-critical in-person interactions and/or interventions with human subjects, an immediate administrative hold applies to the study. The Principal Investigator must review the study procedures of any ORD human subjects’ study he or she is conducting to determine if any of those interactions or interventions are non-critical.

Date Published: 2020-06-22

Why is ORD placing an administrative hold on ORD funded human subjects’ studies involving non-critical in-person research interactions and interventions?

During this period of COVID-19 outbreak, any in-person human subjects research interaction or intervention may place research subjects, research study staff, or other VA patients/employees at risk, therefore, all non-critical, in-person interactions on all ORD-funded human subjects studies must be temporarily stopped in an attempt to decrease virus transmission. Furthermore, VA facilities are increasingly directing clinical resources to handling COVID-19 cases and their prevention. Therefore, an administrative hold will help with enabling these priorities to be met systematically.

Date Published: 2020-06-22

What is meant by critical interactions?

Critical interactions are defined for the purpose of this memorandum as interactions that involve a potentially lifesaving intervention (e.g., IV oncology drug delivery) or an intervention that is required to maintain essential activities of daily living or subject well-being, including mental health and suicide prevention research that cannot occur remotely.

Date Published: 2020-06-22

Does this administrative hold apply to both inpatient and outpatient in-person interactions with human research subjects?

Yes. All ORD-funded studies are impacted by this administrative hold if the study involves non-critical, in-person research interactions.

Date Published: 2020-06-22

Can I still hold group sessions for my research study?

ORD has placed an administrative hold on research activities involving non-critical, in-person contacts between study participants and VA research staff. If you can arrange to have your group meetings via a platform that is approved by the ISSO and you obtain IRB approval, you may continue. Please see the ORPP&E guidance on modifying study procedures: www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf. Please note that if the change impacts the ability to maintain the integrity of the study, your sponsoring ORD service should be consulted before implementing the change.

Date Published: 2020-06-22

If my ORD-funded study involves non-critical, in-person interactions but I would still like to continue other parts of the study, is there anything I can do?

Yes. If it is possible to modify your study procedures to eliminate apparent immediate harm to subjects to eliminate the in-person requirement (e.g., modify current procedures to include online, telehealth, or telephone recruitment, enrollment or follow-up visits) then you may proceed with your study after appropriate notifications (IRB/RD, ORD service). See ORD guidance on modifying study procedures, as well as the FAQs below. www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf.

Date Published: 2020-06-22

If a PI needs to modify a research study in response to COVID-19 is a Project Modification Opportunity (PMO) required?

Diagram 1 included in document.

ORD Guidance for Project Modifications (PMOs), at the end of this document, is intended as guidance regarding when a PMO will be required for changes to studies impacted by COVID-19. If you are unclear as to whether a PMO is required, please contact your VA Portfolio Manager. (Please note that usual PMO requirements remain in place for all modifications to a study that are not related to the temporary COVID-19 impact).

Date Published: 2020-06-22

If my ORD funded study involves only data analysis, does the administrative hold apply to data analysis activities?

No. Data analysis activities do not involve in-person research interactions or interventions with human subjects.

Date Published: 2020-06-22

Does ORD’s administrative hold impact my ORD-funded study if it already only involves remote (online, telehealth, or telephone) recruitment, enrollment or follow-up visits?

No. There is no restriction on remote research study activities from ORD’s administrative hold on non-critical in person interactions or interventions for human subjects’ studies.

Date Published: 2020-06-22

Does the COVID-19 administrative hold apply to laboratory research, including any laboratory research involving biospecimens from human subjects?

This COVID-19 administrative hold is limited to non-critical, in-person research interactions with human subjects for ORD-funded studies. Analyzing biospecimens from human subjects is not an interaction or intervention with human subjects. However, all local facility policies must be followed.

Date Published: 2020-06-22

Are there other study activities I can do while my non-critical, in-person study interactions are placed on administrative hold?

All other approved study procedures may continue such as data analysis and other routine reporting that occurs by electronic transmissions.

Date Published: 2020-06-22

May I use my personal cell phone to contact my study subjects in order to reschedule visits or conduct follow up visits?

Yes, while it is preferred for you use your government phone for government business, if you do not have access to a government phone, there is no prohibition to use your personal phone for telephone calls. Do not use your personal phone to send text messages or emails regarding study visits.

Date Published: 2020-06-22

If I place my study on administrative hold, what should I do?

All investigators, including career development awardees who place their study on administrative hold must notify the ORD funding service by email (see #14 below). The investigator should document in a note to file in their study records and notification to the ORD service that they have:

a. Implemented the administrative hold in response to the CRADOs message.
b. Detail what study procedures are impacted by the administrative hold and what study activities may continue.


While the administrative hold is in effect as of March 17, 2020, the PI should notify the ORD service within 10 days.

Date Published: 2020-06-22

How do I contact my ORD research service?

For Biomedical Laboratory (BLRD): VHABLRD-CSRD@va.gov
For Clinical Science (CSRD): VHABLRD-CSRD@va.gov
For Health Services (HSRD) and/or (QUERI):VHACO.HSRD.ProjectModifications@va.gov
For Rehabilitation (RRD): rrdreviews@va.gov
For Million Veteran Program (MVP): MVPComms@va.gov
For Cooperative Studies Program (CSP): CSP@VA.gov

Date Published: 2020-06-22

If my study is overseen by an IRB, do I have to report this administrative hold to the IRB?

Yes. The IRB must be notified in accordance with local policy (or CIRB policy) if certain study activities are being placed on administrative hold. This reporting must be done within 10 business days.

Date Published: 2020-06-22

If my study is overseen by an IRB and I place certain activities on administrative hold, do I still need to continue other reporting activities to the IRB?

Yes. All other reportable actions in accordance with VHA Handbook 1058.01 must continue to be reported. If your continuing review is due, you must file your continuing review paperwork in accordance with your reviewing IRB’s requirements. The VHA Central IRB has established a process for reporting changes to studies and reporting the administrative hold must follow that same process.

Date Published: 2020-06-22

Should I screen my study participants for COVID-19?

If your VHA medical facility requires the screening of patients presenting for any type of clinical interaction, then you must follow your local guidance. If you are interested in adding the screening for the purpose of your research study, you must file an amendment with the IRB. www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf

Date Published: 2020-06-22

What do I do if my medical facility director implements a more restrictive research policy than the ORD administrative hold?

The medical center director has final authority over actions occurring at his/her facilities. Please notify your ORD funding service if additional restrictions are placed on your research project. If your facility has already notified ORD and provided a copy of the facility COVID-19 notification through the ORDCOVID19@va.gov email about your facility’s policy(ies), no further action is required (please check with your Associate Chief of Staff for Research if they have taken this step).

Date Published: 2020-06-22

If I have a good idea for a COVID-19 research, what should I do?

We are counting on the field to come up with good ideas. We would like you to submit your ideas to ORDCOVID19@va.gov. We need to coordinate efforts that are alike in order to coordinate and maximize the VHA research response.

Date Published: 2020-06-22

Can we collect patient generated data (surveys, questionnaires, etc.) via web-based forms?

VA has approval for two commercial systems outside the VA firewall for the express purpose of collecting patient generated data (surveys, questionnaires, etc.) via web-based forms. Both WESTAT and QUALTRICS can be contracted for using non-OIT funding (research funding). QUALTRICS is approved for FISMA moderate data and WESTAT is approved for FISMA HIGH data so you can select the services, price point and security level for your particular study. If this method of data collection is not part of your current IRB approved study procedures please see the instructions on modifying your study procedures. www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf

Date Published: 2020-06-22

If I am a provider and I have an ongoing ORD-funded oncology interventional drug treatment trial involving Stage 3 cancer patients and a new patient comes to see me in clinic and meets my study enrollment criteria, may I enroll the patient in my study during this administrative hold?

Your study meets the criteria for a critical interaction because enrollment into the clinical trial may be potentially lifesaving. Screening and enrollment into your trial is not prohibited. However, you should evaluate your study procedures to see if any of the follow-up visits could be done remotely, additional risks are incurred by having participate during the COVID-19 pandemic and/or and if possible, modify the procedures as outlined in www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf.

Date Published: 2020-06-22

My research does not involve interactions with patients but it does involve interviews or observations of clinicians. Does this need to be suspended?

Research that involves interactions with clinicians should consider the time demands on clinicians and possible exposures of research staff to infection risk. There may be some studies that can continue with telephone interviews as long as other concerns are managed. We advise you to consult local leaders who may already have issued guidance, but you should avoid research that imposes meaningful burdens on clinicians who are involved in specific aspects of the COVID-19 response. (Note: this does not apply to future research directly aimed at studying the health system impacts of COVID-19).

Date Published: 2020-06-22

Do I need to modify the enrollment status for studies registered in ClinicalTrials.gov that were placed on administrative hold because of COVID-19?

For trials that are in the recruitment phase and affected by the administrative hold, we are asking investigators to evaluate the definitions below and, in general, keep the recruitment status as “Recruiting” or update the status to “Active, not recruiting” depending on the specifics of the trial. We are not recommending the use of “Suspended” for trials on administrative hold.

Not yet recruiting: Participants are not yet being recruited
Recruiting: Participants are currently being recruited, whether or not any participants have yet been enrolled
Enrolling by invitation: Participants are being, or will be selected from a predetermined population
Active, not recruiting: Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled
Completed: The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, the last participant's last visit has occurred)
Suspended: Study halted prematurely but potentially will resume
Terminated: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Withdrawn: Study halted prematurely, prior to enrollment of first participant


To remain in compliance with the Final Rule for FDAAA, the recruitment status for a trial needs to be updated within 30 days of a change. Although we want to avoid unnecessary work for researchers, we also want to ensure that trial records remain in compliance. Also, protocol information available to the public should be kept up-to-date.

Date Published: 2020-06-22

Who should I contact if I have questions about an ORD funded project?

For most questions, your first point of contact should be your local research office. Ensure that you are following their prescribed protocol during work disruption. If additional guidance is needed the research office or the awardee may contact the ORD Service through which the project is funded (see Question #14 above for contact email addresses).

Date Published: 2020-06-22

Can email messages be sent by VA Investigators and approved VA research staff to recruit and communicate with VA subjects?

For information on the use of electronic mail and text messaging for recruiting and communicating with VA subjects, please refer to the guidance from July 28, 2018 titled, Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research. While that specific guidance is still posted as draft, it can be used as the privacy, information security, and human subject regulatory issues have not changed that are addressed in the draft guidance.

There are multiple other questions included in the draft guidance related to use of email and texting in research that may be of help. It is posted on the ORD Policies and Guidance website at https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf.

Please also refer to the Frequently Asked Questions: Institutional Review Board (IRB) and VA Research and Development (R&D) Committee Considerations for Use of Azure Rights Management Services (RMS) in VA Research located at https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf. Azure RMS can be used by VA researchers to send a secure email to communicate personally identifiable information and protected health information (PII/PHI) to VA subjects.

Date Published: 2020-06-22

Where can I find information that details the process to resume ORD-funded in-person research subject interactions?

This information was emailed out to ACOS/Rs and AOs on June 2, 2020 and is saved on SharePoint.

Date Published: 2020-06-22

I would like to continue virtual research appointments for the foreseeable future despite the lift of the Administrative Hold. I am looking into the communication methods listed in the “VA Video Communication Technology Research Memorandum” dated April 7, 2020. Are the methods listed in this memo still applicable despite the hold being lifted?

If you added the video procedures into your research activities in an effort to decrease immediate apparent harms to study subjects and now want to incorporate these procedures as an approved research procedure, you will need to check with your IRB on next steps. In addition to working with the IRB, if permanent changes in methods are being proposed, a Project Modification (PMO) is required (refer to Diagram 1).

Date Published: 2020-06-22

What will happen if ORD offices are closed at the time of research proposal submission?

ORD has a contingency plan for review related staff to work remotely and continue the proposal review process. The field would be notified if any changes in the submission process were needed.

Date Published: 2020-06-22

What If my facility’s research programs are closed at the time of a deadline for research proposal submission?

Your local research office should notify you of their contingency plan. Some will be able to continue operations remotely (from home) while others will not. Those that are unable to continue to function remotely will notify ORD of that fact and will request an extension of deadlines (extensions will be considered on a case-by-case basis and must be received at least 2 weeks prior to the scheduled deadline).

Date Published: 2020-06-22

What if my research program is closed due to COVID-19 pandemic and I am unable to complete preliminary studies that are needed for my submission?

Facilities that are closed due to the pandemic should request a submission deadline extension and can be given a submission extension of up to 2 weeks. Requests for an extension must be received at least 2 weeks prior to the scheduled deadline.

Date Published: 2020-06-22

If research personnel paid on an IPA are unable to work during COVID-19 related laboratory closures will they continue to be paid?

Under the IPA agreement, payment is determined by the institution for whom the employee works, and continued salary payment would be based on local policies.

Date Published: 2020-06-22

Does ORD have plans to fund research on COVID-19?

Solicitations for rapid research projects funded by HSRD and CSRD have been released and is located on the ORD COVID-19 SharePoint. We are most interested in studies that can be executed quickly and inform current practices. Proposed projects should be discussed with the local facilities, including the Associate Chief of Staff for Research (ACOS-R), to ensure that the project will not interfere with clinical activities or impose meaningful burdens on clinicians who are involved in specific aspects of the COVID-19 response. For questions, please email VHABLRD-CSRD@va.gov (CSRD) or vhacoordcoin@va.gov (HSRD).

Date Published: 2020-06-22

Will I be able to contact my portfolio manager during a shut down?

The best way to contact your portfolio manager is via email. Please be patient and the portfolio manager will return your inquiry at their earliest convenience. If the matter is very urgent please make sure that it is clear in your message.

Date Published: 2020-06-22

If a study is unable to continue operations due to COVID-19 facility closures, will ORD approve study budget extensions?

If a study is placed on hold for a period of time due to the COVID-19 pandemic, ORD will accept and review requests to provide additional funding at the end of the award period. The request should be submitted as a PMO, no later than 3 months before the end of the award period. In the meantime, all investigators are urged to use resources wisely especially as study activities are on hold.

Date Published: 2020-06-22

Will my Career Development Award be extended to make up for lost time?

Once operations return to normal, it is expected that awardees will work diligently to expedite activities on the project to help make up for lost productivity. Any request for extensions will be considered on an individual basis with appropriate justification. Consider asking for an extension just prior to the last 6 months of the award.

Date Published: 2020-06-22

What happens if my research office is unable to complete and submit financial and Research Progress Performance Reports (RPPR) by the scheduled due date, due to the effects of COVID-19?

Please be sure to contact the assigned grants management and/or program official to let them know the reports will be late.

Date Published: 2020-06-22

Where can I find Frequently Asked Questions (FAQs) about how animal research is being impacted by COVID-19?

The FAQs for animal research may be found on the VA animal research website at https://www.research.va.gov/programs/animal_research/.

Date Published: 2020-06-22

Do each of my protocols have to be reviewed and approved for restart by the Subcommittee on Research Safety (SRS) and Institutional Animal Care and Use Committee (IACUC)?

The Administrative Hold was NOT placed on Animal and Lab research. We recommend that each facility develop a plan that is vetted by the IACUC and SRS to ensure that there is continuity and consensus in the process of ramping research at your facility. However, if your institution formally placed a hold on IACUC and/or SRS protocols then each protocol that was placed on administrative hold should be reviewed by the committee for restart.

Date Published: 2020-06-22

Do I need to set up an ACC and/or FCP for COVID-19 Research expenses?

Not necessarily. Your local CFOs have been instructed to set up ACCs and FCPs on the health care side to track additional expenses associated with COVID-19. In Research, we do not anticipate that the mission will incur additional expenses at this time due to COVID-19. If you and/or your research staff are pressed into service to support the health care mission, then appropriate expense transfers should be executed between your research FCP and the health care FCPs for any incremental cost your research service might incur. The potential exists that ORD will fund specific protocols associated with COVID-19. If that occurs, project titles will contain “COVID-19” in the project number and remarks for tracking purposes at the national level. For additional questions please contact ORD Director of Finance, Allen Dunlow at Sherman.Dunlow@va.gov.

Date Published: 2020-06-22

When research staff are called to support the Medical Care response to COVID-19, how should the incremental cost be captured?

Any incremental cost incurred by the research appropriation FCPs as a result of supporting the medical care response to COVID-19 should be expense transferred to the appropriate Medical Care appropriation/ACC/FCP established to capture COVID-19 expenses. VATAS should be annotated with the “COVID-19” note in the comments when appropriate.

Date Published: 2020-06-22

Should cost incurred by the Research Appropriation (0161A1) and the Research Office/staff in support of the medical care support to the COVID19 response be captured and expense transferred?

Yes, Facilities have been instructed on capturing cost associated with COVID-19. The medical care side has received or will be reimbursed for COVID-19 expenditures. The CFOs have been provided guidance on what COVID-19 cost to track. Part of that guidance states “Employees reassigned from one position to another position to support COVID-19 such as 1) Clinicians reassigned to other clinical positions due to the postponement of elective procedures, 2) Non-clinicians reassigned to non-clinical positions due to the postponement of elective procedures, and 5) Employees reassigned from normal duties to incident command center and/or labor pool.” There is a 3 and 4 in the guidance to CFOs but is probably not applicable to research. The research appropriation did not receive any supplemental funds to support the COVID response. As such all cost in support of COVID19 need to be expensed transferred to the appropriate ACC/FCP on the medical care side that is capturing these expenses. CDA recipients who may be pulled to full time clinical duties should have their salary expensed transferred accordingly.

Date Published: 2020-06-22

Should the facility purchase all Personal Protective Equipment (PPE) required to enhance safety and protection for staff and patients/research participants as a result of coronavirus with available COVID19 Supplemental funding?

Yes, to maintain the locally established standards of protection, the facility should procure and purchase all PPE for all staff and patients/research participants using the COVID Supplemental funding. To maintain continuity, it is important that the same guidelines applied to medical care regarding PPE needs are also applied to the research community. Should the nature of a particular research protocol require enhanced PPE above this standard level provided by the facility, the respective research protocol can bear the cost of the enhanced PPE after concurrence from the facility.

Date Published: 2020-06-22

Does this process (ORD's publication notification process disseminated on May 1, 2020) replace the use of PubTracker for COVID-19-related publications?

No. It is an additional requirement. PubTracker is for notifications about articles already accepted for publication. For COVID-19 publications, we ask that you notify us at ORDCOVID19@va.gov about articles when they are submitted to journals, even if they have not yet been accepted. We are also asking for notifications on articles being posted as preprints on the web. If an item was previously submitted via email [when it was submitted to a journal, or posted online as a preprint], it should still be submitted to PubTracker upon acceptance for publication in a journal.

Date Published: 2020-06-22

If I notified ORD of a COVID-19-related article when it was posted online as a preprint, do I need to provide another email notification when it is submitted to a journal?

Yes, an additional email notifying us of the change in status would be helpful and appreciated.

Date Published: 2020-06-22

Does this special COVID-19 publication notification process (ORD's publication notification process disseminated on May 1, 2020) apply only if I am the lead, senior, or corresponding author on a study?

As with the standard PubTracker process, we ask that VA investigators notify us of any article on which they are a coauthor. That said, we need only one notification per article. If VA coauthors coordinate among themselves, it is necessary for only one author to notify us and to keep us abreast of changes in status for that article.

Date Published: 2020-06-22

Does the COVID-19 notification process apply only to ORD-funded research?

As with the standard PubTracker process, it applies to any COVID-19-related article reporting on what is considered “VA research.” This includes all research by VA investigators while on VA time or property. VA investigators are those who do research approved by a VA R&D Committee, whether they are FT, PT, WOC, or on detail via IPA. Research can be funded by ORD or other VA or non-VA entities, or unfunded.

Date Published: 2020-06-22

Where can I find more information about COVID-19 and research in VHA?

https://dvagov.sharepoint.com/sites/vacovhacomm/admin/projects/covid19

Date Published: 2020-06-22

The protected research time for PIs (Merit awardees and CADEs) may be impacted during the pandemic (for example, clinician investigators may be required to engage in additional clinical activities and non-clinician investigators may be recruited to the general labor pool at the VAMC). How is ORD addressing this?

ORD understands that PIs must follow local VAMC policies/guidelines and that there may be significant impacts on PIs’ ability to adhere to the documented time commitment to their research projects. As indicated in Diagram 1, a PMO for change in effort on the study is not required at this time. Each ORD Service is committed to successful completion of currently-funded projects and will be receptive to PMO requests based on the impact of interruptions due to the pandemic. The timing of such requests is detailed in Diagram 1.

All ORD Services are offering no cost extensions (NCEs) with a duration up to 6 months for studies with end dates between April 30, 2020 and September 30, 2020. A PMO is not required. On May 4, 2020, the field will receive a spreadsheet populated with the studies that qualify. The station will document the required duration of the NCE, if any, on the spreadsheet provided.

Please note: the station must confirm that the proposed research will be completed by the end of the NCE, as no additional extensions will be allowed.

For studies that do not meet the criteria above, we expect to receive PMOs during the last year of the project and no later than three months before the end date (Diagram 1).

Date Published: 2020-06-22

Given the pandemic, has ORD changed the requirements/timeline for requesting extensions in JIT for studies that are approaching the 180-day deadline?

No. The process remains the same for all ORD Services.

Date Published: 2020-06-22

I have a locally approved project that includes collections of biospecimens from COVID-19 patients as part of a clinical interventional study; the biospecimens will only be used for the specific protocol. Do I need to report this study collection to ORD?

No. If the collection of biospecimens from COVID-19 patients will only be used for the specific protocol, the collection should not be reported to ORD.

Date Published: 2020-06-22

I have a locally approved project that includes collections of biospecimens from COVID-19 patients as part of a clinical interventional study; the biospecimens will be used for future studies. Do I need to report this study collection to ORD?

Yes. The project should be submitted on the R&DC Approved COVID-19 Research submission form. If you have already reported the project, please edit the information to address the biospecimen question.

Date Published: 2020-06-22

I have a locally approved project that includes collections of biospecimens from COVID-19 for future studies. Do I need to report this study collection to ORD?

Yes. The project should be submitted on the R&DC Approved COVID-19 Research submission form. If you have already reported the project, please edit the information to address the specimen question.

Date Published: 2020-06-22

How do I report to ORD collections of COVID-19 specimens obtained for research purposes that will be used for future research?

Please complete the biorepository survey (https://dvagov.sharepoint.com/sites/vacovhacomm/ORD_Surveys/Lists/BioRep_survey/overview.aspx)

Date Published: 2020-06-22

Will ORD provide funding to support the collection of specimens from COVID-19 patients for research purposes?

A number of funding opportunities are available through ORD (https://dvagov.sharepoint.com/sites/vacovhacomm/admin/projects/covid19/SitePages/Research-Opportunities.aspx). At this time, ORD is not reviewing applications that are solely for the collection and storage of biospecimens from COVID-19 patients for future research use.

Date Published: 2020-06-22

Is ORD planning to issue guidance and coordinate nationally a collection of biospecimens from COVID-19 patients for research purposes?

ORD has organized a work group to provide recommendations to the Chief Research and Development Officer on how specimens from COVID-19 patients should be obtained and stored for research purposes at a national level ensuring that human subjects protections, privacy, and ethical considerations are addressed. Additional information will be provided in the upcoming weeks/months.

Date Published: 2020-06-22

Where can I find Frequently Asked Questions (FAQs) about the ORD Guidance on Human Subjects Protections Issues Related to COVID-19 Concerns: Implementation of Clinical Screening Procedures for VA Research Protocols and Modifying Study Procedures?

The FAQs for the ORD Guidance on Human Subjects Protections Issues Related to COVID-19 Concerns: Implementation of Clinical Screening Procedures for VA Research Protocols and Modifying Study Procedures may be found on the ORD Human Research website at https://www.research.va.gov/resources/policies/human_research.cfm#covid19.

Diagram included in original FAQ

CONTINUE TO USE ORD FORM (https://www.research.va.gov/resources/policies/guidance/ORD-ProjectModification.pdf)

SEND to appropriate ORD Service mailbox.

Date Published: 2020-06-22

What options do we have about re-scheduling our AAALAC site visit, or possibly postponing submission of our Program Description?

Because there are so many options, the designated AAALAC institutional representative should contact Dr. Gary Borkowski, gborkowski@aaalac.org, Global Director, to discuss site visit scheduling and Program Description submission options.

Date Published: 2020-06-22

What about impacts on animal facility budgets?

Because the current VA cc105 subsidy is only about 30% of operating costs, any disruption in collection of per diems and other chargeable services could result in funding shortfalls. It is possible that a cc105 approach could be taken (across the board increase), but a major component of cc105 is the number of funded VA projects involving animals, so a case-by-case approach like that in item 6 might be better targeted to fairly address any problems. Some locales will certainly be impacted more severely than others. Please let Mike Fallon know of any problems you are experiencing as soon as possible (404-732-5471).

Date Published: 2020-06-18

What are the Equipment and Access Requirements needed to Conduct a Remote Monitoring Visit?

To facilitate a remote monitoring visit, VA research personnel must have access to equipment and the EHR in addition to setting up an individual Webex account. The following is a list of suggested equipment and access requirements:

• A VA research team member must have access to VA’s EHR through CPRS/VISTA or Joint Legacy Viewer (JLV). o Either CPRS/VISTA or JLV can be used for remote monitoring visits. Some VA research personnel find JLV to be easier to navigate than CPRS/VISTA. The VA research team member should become proficient with navigating CPRS/VISTA or JLV prior to the remote monitoring visit if new to using VA’s EHRs. Detailed training on JLV can be found within the JLV platform: https://jlv.med.va.gov/JLV/app.
A VA research team member must have access to a VA computer with internet capabilities. • Camera capability is recommended either on the computer or through use of a web camera to be able to view the clinical trial monitor (and allow the clinical trial monitor to view the VA research team member).
• It is recommended that only one VA research team member be responsible for managing the computer during the monitoring visit. If interactions with other site personnel are required during a virtual meeting, the VA research team member who is designated as the responsible individual for the visit must retain control of the computer.
• The VA research staff member who will be facilitating the remote monitoring visit must set up a VA Webex account at https://veteransaffairs.Webex.com/.
o The VA research team member does not need to set up a separate VA Webex account for remote monitoring.
o It is recommended that VA research staff members review and take Webex training to increase proficiency with its use. Webex resources are located at the Webex Meeting resource page: https://dvagov.sharepoint.com/sites/OITUCIS/Webex/SitePages/Webex.aspx
• The research staff member should also become proficient in the use of other software applications, such as MS Word, MS Excel, and Adobe Acrobat for documents that will be viewed using these tools.

Date Published: 2020-06-18

What is required when Verifying Regulatory Requirements Prior to Scheduling the Remote Monitoring Visit?

A VA research team member cannot initiate a monitoring visit without verifying that the applicable regulatory requirements are met to allow a monitoring visit to occur. This is not unique to remote monitoring; this applies to any clinical monitoring visit. Both privacy and informed consent regulatory requirements must be verified prior to scheduling the remote monitoring visit prior to initiation of any monitoring visit as follows:

• Consistent with the VA Memorandum titled, “Guidance on Implementation of Approved Methods for Clinical Trial Monitor Access”, the VA research team member must ensure that the signed HIPAA authorizations specifying the disclosure of protected health information (PHI) to clinical trial monitors for the subjects whose records are to be monitored permit access to the records. Clinical trial monitors cannot be granted access to VA subjects’ PHI if a signed, valid HIPAA authorization cannot be produced.
• The VA subjects’ signed and dated informed consent documents do not prevent access by the clinical trial monitors to the subject’s PHI.
• Verification of the regulatory requirements to allow access to the subjects’ individually identifiable information (III) for purposes of the remote monitoring visit may be done by the VA research team or by another party (e.g., privacy officer) dependent upon local VA Facility requirements.
• ORD recommends that the VA research team member document that the regulatory requirements are met prior to scheduling the monitoring visit and place the documentation in the investigator’s regulatory study file (not individual subject files). If a local VA Facility has specific documentation requirements, the local VA Facility documentation requirements must be followed.

Date Published: 2020-06-18

What are the steps to take when Scheduling the Remote Monitoring Visit?

Communication with the clinical trial monitor must occur as part of the process of scheduling a remote monitoring visit. VA research team members must communicate the proposed collaborative conference sharing platform that is to be used when scheduling the remote monitoring visit; VA research team members should not assume clinical trial monitors use the same conference sharing platforms used in VA. The following are recommended practices VA research team members should follow when scheduling a remote monitoring visit:

• Before scheduling a remote monitoring visit with an external monitor, the VA research team member should communicate in writing and/or orally what platform will be used (e.g. Web-Ex) and determine if the monitor has any specific requirements he/she must follow as part of a remote monitoring visit. For example, a monitor may request that the VA research staff member write an email verifying that a remote monitoring visit will be used for the study.

• Similar to any clinical monitoring visit, the VA research team member should request a list in writing to identify the subjects and records required for the record review component of the remote monitoring visit. o Please note that reviewing records remotely requires a longer period of time than reviewing records with the clinical trial monitor at the VA Facility. When scheduling a remote monitoring visit, allow an adequate amount of time to review the records requiring monitoring.

• The VA research team member should request if any non-subject records, such as documents from the regulatory binder, are to be provided in advance of the meeting. The VA research team member should confirm the regulatory site documents to be viewed during the session and the electronic location of those documents (to include the precise records to be reviewed such as, but not limited to, the IRB approval notifications, IRB rosters, research team member CVs, training, and pharmacy accountability documentation).

• The VA research team member should confirm if there are any outstanding issues from previous visits or data queries that are to be addressed during the planned remote monitoring visit. The VA research team member should confirm that those subject records are included in the subject list requested by the clinical trial monitor.

• The VA research team member should request a list of the study staff and other facility staff (e.g., ACOS/R, AO/R, RCO, research pharmacist) required to participate in the virtual meeting and the expectation (e.g., time of day, time required) for their participation.

• Following confirmation of the scheduled date(s) and time of the remote monitoring visit, the VA research team member should send a Webex email invitation to the clinical trial monitor a minimum of five (5) business days prior to the scheduled remote monitoring visit. o The VA research team member can choose to use his or her VA Webex Personal Room to conduct the monitoring visit. A Webex Personal Room is a Webex user’s virtual conference space.

• VA research team should notify the VA Facility research office and other individuals (such as the VA Facility Privacy Officer) if required by local VA Facility research policies to inform them that a remote monitoring visit has been scheduled.

VA research team members should also have a back-up plan if the session is interrupted or terminated early.

Date Published: 2020-06-18

What should be done to test the Equipment Used to Conduct a Remote Monitoring Visit ?

Part of the preparations for a remote monitoring visit include testing the equipment to be used prior to the day of the scheduled remote monitoring visit. This testing is just as important as obtaining the list of records to be reviewed during the remote monitoring visit.

• At least two (2) business days before the scheduled monitoring visit, the VA research personnel should schedule a technical test with the clinical trial monitor to ensure that they can access the platform and has the ability to view documents shared by the VA research team member.
• If the computer being used for the monitoring visit does not have a built-in camera, it is recommended that the site procure an OI&T approved web camera to facilitate the remote monitoring visit.
• This technical test can also be used to confirm the date and time of the remote monitoring visit, review the agenda, and discuss processes that will be used to conduct the visit.

Date Published: 2020-06-18

How can I prepare (stage) Documents for Review during a remote monitoring visit?

Facilitating a remote monitoring visit usually requires more preparation than a monitoring visit occurring when the clinical trial monitor is physically present at the VA. Some records are only available in hard copy and must be scanned in preparation for electronic viewing. The process of preparing the documents for review by a clinical trial monitor is called “staging”. The following are recommended practices VA research team members should use when staging documents in preparation for a remote monitoring visit:

• Based on the purpose and goal of the monitoring visit, the VA research team member should create a rough monitoring visit agenda to be used in staging. If the remote monitoring visit is to take multiple days, it is recommended that a secure shared drive folder on the VA folder of non-patient records to be reviewed and patient list be created in CPRS/VISTA or JLV for each day with the materials required only for that day.
o Do not place the folders on a VA desktop.

• The VA research team member should always utilize computer desk hygiene to prevent accidental access to documents that are not part of the remote monitoring visit. Consideration of desk hygiene should be part of staging the documents in preparation for the remote monitoring visit.
o Remove or file any documents, short cuts, etc., to minimize distractions and avoid inadvertent breaches
o Close all but the specific programs that will be used in the remote monitoring visit including email.
o Enter the information of the subjects to be viewed so that only those specific subjects appear in the recently viewed dialog box in CPRS/VISTA or JLV. This will allow the VA research team member to quickly open the needed information for the current subjects to be reviewed.
o In the secure shared drive folder where electronic research records are stored, stage all documents and subject records that will be used in the remote monitoring visit in a folder created for that specific remote monitoring visit date(s).

• The VA research team member should scan documents that are not available electronically (e.g. informed consent documents not scanned into the EHR) and organize into electronic files or organize the paper documents so that they can be held up for viewing using the camera.

o Scanned documents cannot be altered or modified in any way. For scanned documents, it is recommended that the VA research team member prepare a letter of certification that can be given to the clinical trial monitor verifying that the individual who scanned the document did not modify or adulterate the original document or the scanned version that is available for viewing during the monitoring visit.

• It is recommended that the VA research team member create a patient list in CPRS/VISTA or JLV to simply tasks such as reviewing subject charts.

Date Published: 2020-06-18

What steps should be taken when reviewing records during the remote monitoing visit?

When conducting a remote monitoring visit, it is important to remember that anyone communicating with the clinical trial monitor is responsible to protect subjects’ privacy and confidentiality during and after a remote monitoring visit. The following are recommended practices VA research team members should take when conducting the record review portion of a remote monitoring visit:

• It is recommended that only one VA research team member be responsible for managing the computer during the monitoring visit. If interactions with other site personnel are required during a virtual meeting, the VA research team member who is designated as the responsible individual must retain control of the computer at all times.

• On the day of the remote data monitoring visit, the VA research team member who is the designated responsible individual should ensure that the following items are completed prior to the scheduled time:


o Close all non-relevant programs to include Outlook, Instant Messaging, etc. to prevent the accidental sharing of data that is not related to remote monitoring visit.

o If the VA research team member is running Skype, it is recommended that the VA research team member change his or her status to “Do Not Disturb” during the monitoring visit. This will prevent messages from appearing on the screen during the monitoring visit.

o Ensure that all regulatory site documents are available via the screen and minimized until needed to be opened.

o Ensure that all outstanding issues from previous visits or data queries that are to be addressed during the visit are available via the screen and minimized until needed to be opened.

o Minimize any study specific “Patient Lists”.

• The VA research team member should initiate the Webex meeting with screen sharing off – audio and video only on prior to verifying credentials.

• The clinical trial monitor’s credentials should be verified when initiating the remote monitoring visit. This can be done by the monitor showing his or her respective identification using the camera function of the meeting or another method of verifying the monitor’s credentials.

• The VA research team member and clinical trial monitor should establish the rules for the monitoring visit, e.g., describe the process to be used, review the agenda and adjust as necessary, resolve any unclear points. The VA research team member should not begin sharing the screen for review of records unless both parties are clear on the processes and goals for that day.

• The VA research team member should reinforce to the clinical trial monitor that when reviewing records in the EHR the subjects will be fully identified and no screen shots or recording of any information in any manner from the screen sharing is allowed except for purposes of the monitoring visit (e.g., notes using the subjects’ study identification number findings relevant to the study).

• The VA research team member should share the screen and begin the review of the previously staged research records as outlined in the agenda

o If additional materials (documents, additional patients in the EHR) need to be reviewed that were not part of the originally agreed to list, stop screen sharing and stage these new materials and re-start screen sharing. Update any agendas or logs that may require an update of this information.

• The VA research team member should stop screen sharing at any point in the meeting where active showing for research records is not required.

• If it is necessary for the monitor to privately communicate with other members of the site study staff other than the VA research team member who is the responsible individual, a separate method of communication – such at a phone call – should be arranged. If a separate video conference is required with other members of the study team, then such individuals must meet the same requirement as the VA research team member who is the designated responsible individual. Sharing a login account is a violation of VA policy. The VA research team member in control of the computer must be the same VA research team member logged in.

• If the virtual meeting occurs over several days, the VA research team member and clinical trials monitor should confirm the agenda for the next day so the next day’s materials can be staged.

Date Published: 2020-06-18

What are the steps to take when ending the remote monitoring visit?

Before ending the remote monitoring visit, the VA research team member should request how written observations or the written report of the monitoring visit will be sent by the monitor; this is not unique to remote monitoring visits.

The VA research team member should select “end the meeting” (not “leave the meeting”) to terminate the meeting connection once the work for the meeting is completed.

• The VA research team member should confirm that the Webex meeting has ended. o Note: Only the VA research team member can end the Webex meeting since it was created by him or her.

• The VA research team member should destroy any scanned documents or paper copies of electronic documents created solely for purposes of conducting the remote monitoring visit; these are not federal records and are considered to be working documents.

• The VA research team member should follow local policies and requirements, if applicable, to notify the Research Office that the virtual meeting has ended, and/or if there are follow-ups.

• The VA research team member should retain documents created or completed for the monitoring visit and file these documents with the study regulatory file.

Date Published: 2020-06-18

Can a combined ICF/HIPAA be used if a study involves banking (mandatory or optional)?

No. ORD is working with VHA Privacy on formal guidance on use of a combined ICF/HIPAA for VA research studies involving mandatory banking or optional banking of identifiable data and biospecimens. At the present time, a combined ICF/HIPAA Authorization may not be used for any VA study involving optional banking of identifiable data and/or identifiable biospecimens.

Date Published: 2020-06-18

When a study includes storing of VA data or VA specimen banking as an optional component in a VA research database or VA biospecimen repository, must the subject sign the HIPAA authorization form (VA Form 10-0493) using their full signature or are the subject’s initials acceptable?

Subject initials are acceptable. The HIPAA Authorization Form, VA Form 10-0493 page 5, must be used when banking of identifiable data or identifiable biospecimens is optional. It includes a separate signature line for subjects to agree to the optional banking component of the study. However, it is acceptable for the subject to use his/her initials as their signature when signing the form, as any mark can legally be considered a signature if the subject’s intent was to sign the form.

Date Published: 2020-06-18

If an IRB or Privacy Board has approved a waiver of HIPAA authorization for subjects that do not have personal representatives (PRs), must subjects sign a written HIPAA authorization once they regain capacity?

No. While there is no privacy prohibition to subjects signing a HIPAA authorization when they regain capacity, it is not required by the HIPAA Privacy Rule unless the IRB/Privacy Board-approved waiver of HIPAA Authorization specifies such limitation. It is a best practice to have the subject sign once he/she regains capacity.

Date Published: 2020-06-18

Can data containing PHI/PII be disclosed outside the VA for research purposes under an IRB/Privacy Board approved waiver of HIPAA authorization?

No. A waiver of HIPAA Authorization only provides legal authority to disclose PII/PHI under the HIPAA Privacy Rule. You still need authority to make the disclosure under the Privacy Act and if applicable, 38 U.S.C. 5701 and 7332. Legal authority under these other federal privacy laws may exist to permit the disclosure without the subject's signed, written authorization but that determination must be made on a case by case basis in consultation with your local Privacy Officer.

Date Published: 2020-06-18

How can VA facilities gain access to Remdesivir for the treatmentof severe COVID-19 now that it has been granted Emergency Use Authorization (EUA) by the FDA?

Pharmacy Benefits Management (PBM) coordinates the acquisition of Remdesivir from Health and Human Services (HHS) for use under the EUA. ORD is not involved in the clinical use of Remdesivir. Use of Remdesivir in accordance with the criteria and requirements of the EUA for clinical treatment of VA patients with COVID-19 does not constitute human subjects research; it does not require IRB and R&D Committee approval or reporting to either committee following its use.

For any patients identified as appropriate Remdesivir candidates, clinical staff will work with their local pharmacy department to complete and submit electronically the Remdesivir Order Form to VA’s Pharmacy Benefits Management Services (PBM) office for processing https://dvagov.sharepoint.com/sites/VHAPBM/VA_MedSAFE/COVID/Lists/ROF/Item/newifs.aspx. Jennifer Martin (jennifer.zacher@va.gov) in PBM can be contacted for questions pertaining to obtaining Remdesivir under the EUA for clinical care.

Limited access to Remdesivir remains available outside the EUA as a research use requiring an approved Investigational New Drug Application (IND) through expanded access protocols, emergency INDs for pregnant women and children, and a number of Gilead Science sponsored randomized controlled trials.

Source: https://www.fda.gov/media/137574/download

Date Published: 2020-06-18

Where can VA research offices or VA research staff and Investigators find the most recent schedule for the rollout of the VA Innovation Research Review System (VAIRRS) to VA facilities?

Each VA facility and the VA Central IRB has been assigned to one of three tiers that will be transitioning to VAIRRS according to the following schedule, subject to operations returning to normal in the Fall:

Tier 1 sites will complete transition by July 2020.
Tier 2 sites will begin training in August 2020 and will transition in late September thru October 2020.
Tier 3 sites will begin training in November 2020 and will transition in late December 2020 thru January 2021.


A list of tier assignments can be found on ORPP&E’s webpage here: https://www.research.va.gov/programs/orppe/vairrs/VAIRRS_Tiers.pdf

Date Published: 2020-06-18

Does the VA Central IRB have a streamlined process for reviewing COVID-19 research studies submitted for review?

Yes. The VA Central IRB (CIRB) is prioritizing COVID-19 studies that have been cleared by the ORD COVID-19 Steering Committee, have been funded by ORD, or COVID-19 amendments added to currently approved studies overseen by the CIRB. For those COVID-19 studies requiring review by the convened IRB, ad hoc meetings are held to ensure as timely a review as possible. Otherwise, the submission and review process are the same as for non-COVID-19 studies. All other VA CIRB business is conducted at the regularly scheduled meetings.

Date Published: 2020-06-18

What level of RCO audit, if any, is required for human subjects research that is exempt from the Common Rule?

Research Compliance Officers (RCOs) may be required to audit exempt research; audit requirements differ depending on when the study was determined to be exempt.

Annual Informed Consent Audit: While exempt studies do not have IRB approved informed consent forms, RCOs are required to conduct an annual informed consent audit of ALL exempt studies. The audit requirement for exempt human research is fulfilled by completing or re-confirming the administrative data section of the ORO informed consent audit tool (or locally-modified equivalent). The box for “exempt” should be checked, and the auditor should confirm that the R&D Committee has performed initial and/or continuing reviews as required by VA policy for any active study that is not followed by any other research oversight committee (see section 2.b. of the RCO Audit Guidance).

Regulatory Audit: Only exempt studies that are subject to the 2018 Common Rule are required to undergo RCO regulatory audits, i.e. studies determined to be exempt on or after January 21, 2019 or exempt human subjects research activities approved by an R&DC prior to January 21, 2019 for which a VA facility has documented that the research has transitioned to the 2018 Requirements (see section 3.b. of the RCO Audit Guidance). Exempt studies that are subject to the 2018 Common Rule require a one-time completion of the administrative portion of the HRPP regulatory audit tool, as well as the “STUDY STAFF QUALIFICATIONS AND TRAINING” portion of the tool.

If a study was approved by expedited review under the pre-2018 Common Rule and after January 21, 2019 was transitioned to the 2018 rule and is determined to be exempt, the following apply to fulfill the regulatory audit requirement of this now-exempt study:

If the study had a full HRPP regulatory audit prior to its transition to the 2018 Common Rule, the study only needs to have a one-time limited/exempt HRPP audit after transition.


If the study did not have a full HRPP regulatory audit prior to transition, the study needs to have a one-time full HRPP regulatory audit (look-back to study initiation) after transition.

Date Published: 2020-06-18

Is it possible to obtain central ISSO review of VA multisite research studies submitted to commercial IRBs, similar to how the VA Central IRB ISSO performs a central ISSO review of studies submitted to the VA Central IRB?

Yes. For VA facilities who are participating in research protocols that are submitted through the VA Central Office (VACO) Central IRB (CIRB), an OIS-Research Support Division Enterprise ISSO will provide a standardized ISSO review. We are currently coordinating with both ORPP&E and the Cooperative Studies Program (CSP) to develop a process to facilitate an enterprise level ISSO security review process for facilities who are participating within either multi-site Clinical Trials, or research protocols that are submitted through a commercial IRB.

Date Published: 2020-06-18

How can a Principal Investigator obtain additional assistance and guidance on information security issues impacting their research?

The Research Support Division encourages Principal Investigators to work with their local Facility ISSO who serves as a primary point of contact for research related information security questions/concerns. However, if the local Research Program/Facility PI is experiencing protocol review/assessment delays, we recommended the PI engage the ISSO’s Information System Security Manager (ISSM) or Team Lead for resolution. If the PI, or the Facility ISSOs are seeking additional guidance, a request can be submitted to Research Support Division to provide guidance/assessment on the specific Research Information Security issue by emailing the OITITOPSSOESOResearchSupportDivision@va.gov distribution list. Research Support Division will work collaboratively with both the PI and the local facility ISSO to provide guidance, direction, and support to resolve your questions/concerns.

Date Published: 2020-06-18

Is RedCap approved for use in VA research?

Yes. The VA approved REDCap instance hosted behind the VA Firewall is the only instance of REDCap approved to store, process, and transit VA Data that is not protected health information. The System Owner is Dr. Breeling. The RSD is working on an Authority to Operate to be able to store, process and transmit PHI/PII, but it is not in place at this time. Additional information on the use of VA REDCap is available on VIRECs REDCap portal.

Other External (Affiliate, Sponsor, etc.) provided Instances of REDCap require review by the Facility ISSO during the Institutional Review Board (IRB) and Research & Development Committee protocol review process.

Date Published: 2020-06-18

Can VA REDCap be used to collect Protected Health Information (PHI) or Personally Identifiable Information (PII) from research subjects?

No. VA REDCap instance has not been approved for the storage, processing or transmission of data containing PHI/PII. VA REDCap is currently being recategorized through the Assessment & Authorization (A&A) process for inclusion of PHI/PII which requires both System Owner and OI&T Authorizing Official (AO) approval. RSD will continue supporting the System Owner through this recategorization process. Continued updates of REDCap’s status can be reviewed both on VIREC’s REDCap portal and RSD’s Application Information System Tracker.

Date Published: 2020-06-18

Is it permissible to scan subject signed informed consent forms and HIPAA authorizations containing PHI/PII using scanner/copy machines available in each Service for the purpose of auditing electronic documents?

There have been no published restrictions on scanning signed informed consent forms and signed HIPAA Authorization using the facility's approved secure Multi-Functional Device (MFD) Printer. OIS-Research Support Division recommends PIs and the Research Service coordinate with their Facility ISSO and/or Area Manager/IT Support to ensure MFD Printers have been configured and approved for scanning documents containing sensitive information. The Facility ISSO and/or Area Manager/IT Support are responsible for ensuring the Multi-Functional Device adheres to the VA Security Policy and the approved Printer and Multifunction Device Secure Configuration Baseline.

Date Published: 2020-06-18

What are the approved methods for transferring data externally/outside the VA?

The following methods are approved for transferring data externally/outside the VA:

Sensitive Data: 1. VA Issued, Encrypted (FIPS 140-2 Validated) Thumb Drive
2. VA Issued, Encrypted (FIPS 140-2 Validated) External Hard Drive
3. Encrypted (FIPS 140-2 Validated) CD/DVD
4. Azure RMS (The Affiliate can include sensitive information in a reply to an VA originated Azure RMS email)
5. Research Study Sponsor eCRF (For Data Owned by the Sponsor, sensitive data must be encrypted in transmission with FIPS 140-2 validated encryption).


Non-Sensitive Data Non-Sensitive data can be transferred using the methods above and can also be sent using unencrypted email.

Guidance is provided here for reviewing the approved whitelist of approved portable storage devices. RMS Azure email transfer is approved and guidance is available from both ORD’s “FAQs: IRB and R&D Committee Considerations for Use of Azure RMS in VA Research” and OI&T’s “User Guide for External Azure RMS Recipients” published guidance. Additionally, guidance for the eCRF review process is detailed within ESO Bulletin 364, “Release of VA Research Data to Non-VA Entities and External Web Portal Reviews”.

Date Published: 2020-06-18

Are Information System Security Officers (ISSOs) required to complete Collaborative Institutional Training Initiative (CITI) training in ethical principles governing human subjects research?

No. There is no requirement from ORD, Enterprise Security Operations (ESO), or Office of Information Security (OIS) for ISSOs to complete Collaborative Institutional Training Initiative (CITI) training. Facility ISSOs are required to review the ESO Research Information Security Compliance Standard Operating Procedures (SOP) and are recommended to take the following OIS-Research Support Division ITWD developed courses:

1. VA Research Overview for Information System Security Officers and Managers (ISSOs/ISSMs)
2. Research Institutional Review Board ISSO Protocol Review
3. Research Electronic Case Report Form (eCRF)/Web Portal Security Review for ISSOs

Date Published: 2020-06-03

Can an R&D Committee chair or designated member of the R&D Committee approve research through the designated review process?

Yes. VHA Directive 1200.01, Paragraph 9.e. allows the R&D Committee to review the activities defined in the applicable ORD policy using a designated review process. However, only the R&D Committee Chair or a voting member designated by the Chair can review and approve the activity on behalf of the R&D committee. If the research study is eligible for designated review at initial approval, subsequent actions that are required to be approved by the R&D Committee on the study, to include approval of amendments and continuing reviews, for studies overseen solely by the R&D Committee can also be approved by designated review.

Date Published: 2020-06-03

When does the designated R&D Committee reviewer have to report the review approval to the R&D Committee?

Final initial R&D Committee approval of research by designated review must be reported to the full R&D Committee at its next convened meeting and noted in the minutes (VHA Directive 1200.01, Paragraph 9.b.(1)). The R&D Committee’s standard operating procedures (SOPs) should specify how approvals by designated review are communicated to the rest of the committee and the timeframe for communication. While ORD policy does not currently require reporting of other designated review approvals, such as exempt research, to the convened R&D Committee, ORD recommends that all designated review approvals be reported to the R&D Committee and noted in the minutes. ORD does not prescribe a specific method for VA facilities to report designated review approvals to the R&D Committee. However, ORD recommends that a minimum of the name of the research study, name of Principal Investigator, the type of designated review action (e.g., exempt research approval; final approval after ISSO and PO reviews), and date of designated review approval be included in the information reported to the R&D Committee.

Date Published: 2020-06-03

For research under the sole oversight of the R&D Committee, is the R&D Committee required to approve changes to investigators?

Yes. It is the responsibility of the overseeing committee to ensure the availability of qualified research team members, including investigators, who can conduct the approved research. Changes to investigators, to include Principal Investigators/co-investigators/sub-investigators, constitute amendments to approved research. Amendments to approved research under the sole oversight of the R&D Committee must be submitted to the R&D Committee for approval prior to implementation.

Date Published: 2020-06-03

Is the R&D Committee required to approve research under the oversight of a research-related subcommittee or committee?

Yes. The R&D Committee must provide final approval of VA research before the research can be initiated regardless of the committee or subcommittee that will oversee it. Final R&D Committee approval can only be granted once the R&D Committee has received documentation from all applicable subcommittees/committees of their review and non-contingent approval (VHA Directive 1200.01, Paragraph 9.b.(1)). However, because emergency use of a test article under FDA regulations does not require prospective IRB approval, prospective R&D Committee approval is also not required.

Date Published: 2020-06-03

After initial approval, is the R&D Committee required to approve lifecycle actions of studies such as continuing reviews, amendments, reportable events, etc.…?

Yes, however, only if the R&D Committee is the only committee overseeing the study. If another committee or subcommittee is responsible for overseeing the lifecycle actions of the study, then the R&D Committee is not required to approve those actions (VHA Directive 1200.01, Paragraph (1200.01 Paragraph 9.b.(4) and 9.c.(3)). Committees and subcommittees may request that the R&D Committee review an action (e.g. an amendment is submitted that has the potential to significantly impact the facility) or ORD policy may require that the R&D Committee approve an action (e.g. approval of an amendment to add non-Veteran enrollment in VA research (VHA Directive 1200.01, Paragraph 13.a.)).

Date Published: 2020-06-03

When is ACOS/R&D notification required for R&D Committee actions?

After the research project has been granted final approval by the R&D Committee, the ACOS/R&D is responsible for notifying investigators, in writing that the research project can be initiated, and the period for which the project is approved (VHA Directive 1200.01, Paragraph 5.g.(2)). Local policy will dictate timeframes and format for that notification.

Date Published: 2020-06-03

Does the ACOS/R&D have to notify investigators of approvals of amendments and continuing reviews by the reviewing subcommittees or committees?

No. There is no ORD policy requirement for notification by the ACOS/R&D of subsequent subcommittee or committee actions, such as approval of amendments or continuing reviews, in addition to the notifications sent by the reviewing subcommittees or committees.

Date Published: 2020-06-03

If a study is not approved by the R&D Committee is the ACOS/R&D required to send a letter to the investigator?

No. There is no ORD policy requirement for the ACOS/R&D to notify the investigator in addition to the R&D Committee’s notification of the study disapproval (VHA Directive 1200.01, Paragraph 9.b.(3).

Date Published: 2020-06-03

What is the best way to make sure that actions on research under the oversight of a subcommittee or committee are communicated to the R&D Committee?

There is no single best way to ensure that actions on research under the oversight of a subcommittee or committee are communicated to the R&D Committee. Different factors impact when and how actions are communicated and will vary among committees, including use of electronic vs. paper-based systems.

R&D Committee subcommittees are required to provide the R&D Committee with copies of subcommittee minutes within 60 calendar days of the finalization of the minutes. A well-constructed quality assurance program at your site will also help to ensure that the reporting of minutes is happening within the required 60 calendar days of finalization. The minutes must include information on actions approved by the convened committee as well as a list of actions that were approved outside of committee, via an expedited (IRB) or designated member review (IACUC and SRS) process.

The Memorandum of Understanding (MOU) or reliance agreement between the VA facility and the external committee must stipulate how actions approved by the committee will be communicated to the R&D Committee. The MOU or reliance agreement should be reviewed on at least an annual basis to ensure the obligations detailed in the MOU are being met.

Elements of the MOU should include:

a. How the R&D Committee will be made aware of actions approved by the committee, to include a mutually agreed upon time frame for such notification. Notification can take the form of submission of meeting minutes, a list of actions approved, copies of approval notices, or some other means by which the R&D Committee is made aware of actions that have been approved by the committee.
b. A provision to allow the VA facility access to unredacted copies of meeting minutes within 2 business days of a written request to allow the R&D Committee to review deliberations on VA protocols.
c. Information on how the R&D Committee will either receive copies of actions and the supporting documents approved by the committee or be able to access those records remotely.

Date Published: 2020-06-03

For studies overseen by an external committee, does the R&D Committee need to retain copies of the complete protocol file on all actions approved by the external committee?

No. The R&D Committee is not required to physically maintain a copy of the complete protocol file on all actions approved by the external committee. However, the R&D Committee must have the ability to access the protocol file if it does not physically maintain a paper or electronic copy of the complete protocol file. VHA Directive 1200.02, Paragraph 12.a.(4)(c) requires VA research to maintain and control a copy (paper or electronic) of all approved Research Protocols, amendments, consent document templates, and other documents submitted to a research review committee/subcommittee, and documents related to the actions of the research review committees.

Date Published: 2020-06-03

For research under the sole oversight of the R&D Committee, is the R&D Committee required to approve changes to study team members who are not investigators?

Yes, if the names of the study team members are named in the protocol, information sheet received by VA subjects or advertisement materials. Changes in study team members who are not investigators on committee applications are not required by ORD policy to be approved by the R&D Committee prior to that individual being permitted to work on the study. Changes in personnel are required to be reported to the R&D Committee annually as part of the R&D Committee’s continuing review requirements (VHA Directive 1200.01, Paragraph 9.d.(2)(a)(3)). R&D Committee SOPs must specify when such changes in study team members are to be submitted and how they are reviewed.

However, any study team member cannot be a VA study member unless they have the required appointment, qualifications, and training. For example, a VA Investigator cannot add a study team member as a member of the VA research team who does not have a VA appointment. VHA Directive 1200.02, Paragraph 14.a.(7) requires the VA Principal Investigator to ensure that all research staff are qualified (including but not limited to appropriate training, education, expertise, and credentials) to perform procedures assigned to them during the course of the research. Written procedures must be in place to ensure that all research personnel hold an official VA appointment from HRMS (as a compensated, full-time or part time employee, a WOC, or under an IPA) prior to conducting or being involved in any way in VA research activities, and that the individuals maintain their appointment while conducting or being involved in any way in any VA research activities.

Date Published: 2020-06-03

What is required of the R&D Committee and the PI if there is a lapse in approval for studies that are under the sole oversight of the R&D Committee?

A lapse of R&D Committee approval is an expiration of study approval. For studies requiring R&D Committee continuing review, the time frame for R&D Committee approval cannot exceed 365 days (VHA Directive 1200.01, Paragraph 9.d.(1)(d)). When a study has lapsed R&D Committee approval, the study no longer has any institutional approval to be conducted by the VA Investigators. A study cannot be conducted without approval.

The R&D committee must have written policies and procedures for recurring processes (VHA Directive 1200.01, Paragraph 6.3.). For continuing review, the R&D Committee must have written policies and procedures for conducting continuing review, including processes for investigator submission and R&D Committee review procedures. If approval expires for a study under sole oversight of the R&D Committee, the R&D Committee must notify the investigator that R&D Committee approval has expired and all study activities must stop, including any data analyses. Any requirements for continuing review submission or review of received materials must be completed before approval can be obtained following expiration of the study’s approval. Once approval is obtained, the study continuation written notification is sent to the PI. If the requirements for continuing review submission or review are not completed, the study must be closed. The R&D Committee should include in its written policies and procedures time frames by which additional actions such as study closure will occur following expiration of study approval.

ORD wishes to emphasize that R&D Committee written policies and procedures should be put in place to prevent lapses in study approval when the R&D Committee is the sole oversight committee. When a study lapse occurs, the R&D Committee should evaluate the root cause of the lapse in study approval, and if appropriate, initiate correction actions and/or revise policies and procedures to remediate or prevent lapse of R&D Committee continuing review approvals.

Date Published: 2020-04-26

Our facility providers have talked about contacting our Veteran COVID patients that have recovered and asking them to donate for the convalescent plasma study. Would they need a research protocol approved to recruit patients to donate for this purpose?

No. Donating plasma is not part of the research study. Providers should only reach out to patients who they have personally treated. Providers may not access the records of patients who they have not treated who have had COVID infection solely for the purpose of contacting them to donate plasma. Check with your local Privacy office for any restrictions.

Date Published: 2020-04-26

Can we reach out through Employee Occupational Health for our site to our employees who had COVID-19 and recovered to donate plasma?

Your local human resources office will have to answer that question.

Date Published: 2020-04-26

Where can people donate plasma who have had COVID (lab diagnosed) and are 28 days without symptoms?

Any American Association of Blood Bank Donor Center. http://aabb.org/sa/facilities/bbts/Pages/BBTSAccrFac.aspx

Date Published: 2020-04-26

Can you ask whether potential donors 1) need to have a repeat negative COVID-19 test, 2) whether donors get paid to donate plasma?

See the FDA: Recommendations for Investigational COVID-19 Convalescent Plasma for donor requirements.

There are established donor qualification requirements in addition to COVID-19 Convalescent Plasma INDs requirements. Check with your local blood supplier for Blood Donation Eligibility Requirements. Blood Donation Eligibility Requirements source American Red Cross

Date Published: 2020-04-13

What about animal to human or human to animal transmission of COVID-19?

There were some initial reports that dogs might possibly carry the virus, but those reports appear to be false. The American Veterinary Medical Association has released the following guidance (https://www.avma.org/resources-tools/animal-health-and-welfare/covid-19):

“Out of an abundance of caution, it is recommended that those ill with COVID-19 limit contact with animals until more information is known about the virus. Have another member of your household take care of walking, feeding, and playing with your pet. If you have a service animal or you must care for your pet, then wear a facemask; don’t share food, kiss, or hug them; and wash your hands before and after any contact with them.”

Note: As is true of almost all pathogens, animals such as nude mice and SCID mice that have severely compromised immune systems could be at increased risk of becoming infected with COVID-19 (or any other virus). It is standard practice in the laboratory animal community to house these rodent strains under special conditions to carefully protect them from environmental infectious agents, which include the use of PPE such as masks and gloves for people who are handling them. Such practices should of course continue.

Date Published: 2020-04-13

What about the use of Personal Protective Equipment in the animal facility?

Keep in mind that the very best safety practices are to wash hands frequently and to not touch the eyes, mouth, or face with unwashed hands. No changes in PPE practice in the animal facility are needed unless additional PPE is required per hospital policy or suggested by best practices to prevent the spread of COVID-19 between staff members.

Date Published: 2020-04-13

Our station is scheduled to have an AAALAC site visit in the summer or fall of 2020; given the COV-19 restrictions, should we ask for the site visit to be postponed?

Each station, in consultation with their affiliate university as is appropriate, should decide if postponement of the site visit is needed. If the decision is to request postponement of the upcoming site visit, the designated AAALAC institutional representative should contact the AAALAC Executive Office (accredit@aaalac.org) by email and request that the site visit to be postponed. Your six-digit AAALAC unit number should be included in the request.

Date Published: 2020-04-13

Are the changes described in FAQ 15 (i.e. waivers of VA animal research policy) permanent changes in VA policy, or only interim measures for addressing the current situation with COVID-19?

The changes have been under discussion for some time, so we expect that they will eventually be incorporated in the new version of 1200.07 (which will be a Directive rather than a Handbook, and is close to going into concurrence now). Accordingly, the best interpretation right now is that they are permanent.

Date Published: 2020-04-13

If our local SOPs specify more stringent requirements than these changes allow, do we have to have the IACUC formally vote to approve the changes in each of the current SOPs?

Normally, if you have more stringent local policies, they take precedence over less stringent regulatory requirements. Under the current “extraordinary circumstances” though, all parties are trying to provide as much flexibility as possible, without jeopardizing animal welfare and personnel safety. We spoke with OLAW this week, and they agreed that it will suffice if your IACUC agrees generally to accept the changes allowed by VA, in place of your existing SOPs (this doesn’t have to be done separately for each SOP). They reminded us that there is actually no regulatory requirement for SOPs to be formally approved by a majority vote at a convened meeting of a quorum – it’s only necessary for someone on the IACUC to recommend them, all members to have the opportunity to register any concerns they may have, and all members to be informed of them. The same applies to changes in the SOPs.

Date Published: 2020-04-13

If our PHS Assurance commits us to more stringent requirements than OLAW grants us a waiver for, do we have to formally process a modification of the Assurance with OLAW?

Again, normally, if your Assurance has more stringent requirements than PHS Policy, you are committed to complying with your Assurance. In this case, if you receive a waiver from OLAW, our understanding is that the waiver indicates OLAW’s approval for your station to treat the more flexible requirements as incorporated into your Assurance. As usual when you modify your Assurance, you should note this in your next annual report.

Date Published: 2020-04-13

How do we avoid problems if we get audited or site-visited sometime in the future, when all this is over, and our records show that we did not comply with the normal regulatory requirements?

To prevent confusion in the future, we recommend that you put a copy of whatever waivers or FAQs you are relying on, and some documentation that your IACUC accepted them, into the files of whatever matters are affected.

Date Published: 2020-04-13

Will we lose our AAALAC accreditation if the site visit isn’t conducted within three years of the last site date?

No. According to AAALAC senior staff, accreditation status will be unchanged even if the site visit is conducted later.

Date Published: 2020-04-13

The time to conduct our semiannual facility inspections is approaching but due to COV-19 restrictions, we do not want to gather groups of people together. What options do we have?

VA adheres to PHS Policy, which is administered by the Office of Laboratory Animal Welfare (OLAW). OLAW has offered the flexibilities to IACUCs in a new guidance document (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-088.html) when planning for semiannual program and facility assessments:

Assessments may occur up to 30 days past the semi-annual date of the last assessment as long as the date has not drifted forward from year to year. If you anticipate the need for more than a 30 day delay, a waiver may be requested from OLAW for additional flexibility in scheduling assessments by submitting a written justification to OLAW at olawdpe@mail.nih.gov.

VHA Handbook 1200.07, par. 8.f(1)(d)5 requires “At least three IACUC members (including the veterinarian) need to conduct the program and facilities review, unless exceptional circumstances prevent attendance.” VA considers the current circumstances to be “exceptional”, and it is acceptable to limit the number of participants in the semiannual evaluation to the minimum allowed by USDA and OLAW.

If USDA species are not involved, which requires a minimum of two IACUC members to participate, the IACUC may use a single “qualified individual” to conduct program or facility reviews. The “qualified individual” be an IACUC member or an ad hoc research or animal caretaker staff member.

Keep in mind that the findings of the individuals who conduct the program and facility reviews must still be evaluated by the IACUC, to determine whether deficiencies are “minor” or “significant”, to analyze their root causes, and to decide on appropriate corrective measures and timelines for completion. The report is not considered final until it has been signed (electronically is fine) by a majority of the total voting membership of the IACUC.

Note: if you had a recent AAALAC site visit, that visit can be used as your semi-annual IACUC self-assessment, but the VA semi-annual form will need to be completed, based upon the site visit findings. The out-briefing provided by the AAALAC site visitors to medical center managers at the end of the visit (to summarize the preliminary findings) satisfies the requirement for a meeting with the IACUC to discuss the semi-annual self-review (see also FAQ item 15.e below).

Date Published: 2020-04-13

How can we have IACUC meetings and still practice social distancing measures to help prevent of COVID-19 transmission?

OLAW recommends the following measures ((https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-088.html) when planning for semiannual program and facility assessments:

The IACUC may institute alternatives to face-to-face meetings such as teleconference or video conferencing (see NOT-OD-06-052).

The number of IACUC meetings may be reduced to as few as one every six months.

The IACUC may choose to expand their use of designated member review in lieu of full committee review.

Date Published: 2020-04-13

What waivers of VA animal research policy are available to reduce IACUC burden and reduce the need for face to face meetings while concerns about COVID-19 require social distancing?

Effective immediately, the following requirements in VHA Handbook 1200.07 (https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2464) are waived or changed as indicated below, to support social distancing efforts and reduce IACUC burden. Electronic signatures continue to be acceptable on all VA animal research documents. You will need to notify OLAW of any changes needed in your Assurance to match any practices adopted below (see FAQ 18 for details).

a. Paragraph 7.c., Standard Operating Procedures (SOPs) [Page 15]. The requirement for annual review of animal facility SOPs is waived, and replaced with a requirement for review at least every three years.

b. Paragraph 8.a., Membership, Composition, and Terms of Service [Page 18]: Letters of appointment by the Medical Facility Director no longer must stipulate the length of IACUC member appointments, may be in the form of an email, and may remain in force until rescinded by the Medical facility Director. The term requirements in paragraph 8.a.(7) [Page 20] for IACUC members are rescinded.

c. Paragraph 8.f.(1)(b), IACUC review of Records [Page 23]: The requirement for IACUC random review of IACUC records is rescinded.

d. Paragraphs 8.g. (Annual Review of Proposals) and 8.g.(1) (First and Second Annual Review of Protocols)[Page 28]: The requirement for annual reviews of protocols involving non-USDA species is rescinded; such protocols must be reviewed at least every three years, consistent with PHS Policy.

e. Appendix E, item 7.e. [Page E-10]: The requirement for a face to face meeting with the Medical Facility Director to discuss the results of the IACUC semi-annual self-review is clarified to include meetings conducted by teleconference or videoconference, as described in Guidance Document AR2016-001 on https://www.research.va.gov/programs/animal_research/guidance.cfm.

f. Appendix E, item 7.f [Page E-10]: A signed copy of the completed IACUC semi-annual self-assessment must now be sent through the ACOS for R&D and the Medical Facility Director to the CVMO within 120 days of the date on which the report is finalized, as indicated by the signatures of a majority of the total voting membership of the IACUC, instead of within 60 days.

Date Published: 2020-04-13

If an investigator wants to plan to perform animal research with COVID-19 virus, what containment practices will have to be followed?

All studies involving infectious COVID-19 must be conducted at Biosafety Level 3 (BSL-3), as defined in the CDC Biosafety in Microbiological and Biomedical Laboratories, 5th Edition.a For the requirements specific to animal studies, see Section V, “Vertebrate Animal Biosafety Level Criteria for Vivarium Research Facilities.”

The World health organization has released specific guidance for COVID-19 studies, which requires includes a requirement for BSL-3 containment practices for bench and animal research.

There are two major issues to address when planning for or proposing animal studies with COVID-19:

Facilities. Few VA facilities have onsite laboratory ABSL-3 containment facilities. The process of converting existing space to ABSL-3 space is lengthy and requires expert technical consultation on many issues. If your station does not have its own ABSL-3 facility, a far better option is to utilize another institution’s off-site facility.There is a process developed by ORDc for such off-site BSL-3/ABSL-3 facility use requests. Please contact Dr. Amanda Hunt (Amanda.hunt@va.gov) immediately if you anticipate the need for a waiver to utilize such an off-site facility.

Training. Safely working with agents in ABSL-3 containment conditions requires extensive training, and possibly higher security clearances. Accordingly, it would be wise to consider partnering with a group that already has the necessary experience and clearances to reduce delays.

References for this item:

a. https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF
b. https://www.who.int/docs/default-source/coronaviruse/laboratory-biosafety-novel-coronavirus-version-1-1.pdf?sfvrsn=912a9847_2
c. https://www.research.va.gov/resources/policies/off-site.cfm; see item 5.

Date Published: 2020-04-13

Does the COVID-19 administrative hold announced by the Chief Research and Development Officer apply to animal research?

No, the COVID-19 administrative hold applies to research interactions with human subjects.

Date Published: 2020-04-13

How can we help protect critical animal care staff to ensure continuity of animal care?

In general, if conditions warrant it locally, stations may institute measures as needed to help prevent COVID-19 infections in the animal care staff by limiting access to the animal facility to as few people as possible. The situation is changing across the country on a daily basis, and if the perceived risk to the animal care staff increases locally due to any number of possible factors, Research Services are authorized to limit entry to the animal facility to just designated essential research technicians and staff to minimize the chance of COVID-19 transmission between people.

Also, to reduce the opportunity for all caretaker staff to be exposed at the same time and to become ill at the same time, it is wise to consider varying the tours of duty so that all care staff are not present at the same time. Keep in mind that it is best to always have two animal care staff members present at all times, although this will not necessarily be possible in small facilities.

Date Published: 2020-04-13

Our program is experiencing challenges with maintaining our animal facility or supporting ongoing animal research activities due to COVID-19 restrictions. What should be our priorities and what do we do?

If these FAQ items on animal research do not resolve problems, or you have an emergency issue, call Mike Fallon, CVMO, at 404-732-5471. If there are less pressing concerns regarding the management of animals during this period, email Michael Fallon (michael.fallon@va.gov), Alice Huang (alice.huang@va.gov), and Joan Richerson (joan.richerson@va.gov).

The first priority is to ensure that proper care continues to be administered to all VA research animals during the agency response to COVID-19 infections in people. Just as care of hospital and clinic patients must continue, care for the animals must continue.

As containment procedures continue to evolve, all programs must remain in good communication with hospital response teams to ensure that any required employee PPE use or other practices are adopted as needed to ensure continued care for the animals. Please continue to read and monitor agency emails concerning ongoing containment practices.

Date Published: 2020-04-13

How do we deal with possible animal care staff shortages caused by COVID-19 infections, quarantine procedures, or other restrictive policies intended to prevent transmission between people?

A very good approach is to immediately train some research technicians with animal research experience in the basic skills needed to care for the animals as backups, in case of disruptions in animal care staffing. The greatest threat to the animals is the loss of onsite personnel who know how to change cages, provide water and food, and provide treatments without compromising quarantine or special barrier procedures that could put many animals and studies at risk. In addition to the animal care staff and veterinarian, research technicians have a great deal of knowledge about research animals, and in unusual circumstances, can be invaluable backups in maintaining animal care.

If local circumstances allow, neighboring institutions might also be able to provide additional caretaker support.

Date Published: 2020-04-13

How can we mitigate the impact of COVID-19 containment procedures on VA funded animal studies?

Please reach out to investigators conducting animal research and find out if there are any longitudinal studies underway with multiple time point interventions, or any studies that are heavily dependent on the current age or weight of animals. Find out what is needed and coordinate with the Attending Veterinarian, VMU Supervisor, and animal care staff to make any needed arrangements so that those studies can continue to receive support and not end up with lost animals due to incomplete data collection.

For those studies that do not have time-sensitive studies, it would be very wise to postpone them until the COVID-19 situation stabilizes, and the possibility of staffing disruptions decreases.

Likewise, it is best to postpone new animal research studies that are heavily resource dependent or would be compromised with the loss of just one or a few key staff members.

Date Published: 2020-04-13

What if delays or unfortunate disruptions prevent an investigator from completing key animal studies, thus raising concerns about progress on a VA-funded project?

Please see the ORD plan for general research disruptions due to COVID-19, which will be considered on a case-by-case basis.

Date Published: 2020-04-07

Can a waiver or alteration of HIPAA authorization be used to disclose protected health information (PHI) when written HIPAA authorization cannot be obtained from VA research subjects who are in COVID-19 isolation?

VHA does not permit alterations of authorizations, so IRBs or Privacy Boards cannot grant an alteration of authorization eliminating the requirement for signatures or dates of the subject or the subject’s personal representative. However, if a written authorization cannot be obtained from the subject who is in COVID-19 isolation or subject’s personal representative because he or she is unable to enter the hospital because of isolation precautions, the IRB or Privacy Board may approve a waiver of the requirements of written HIPAA Authorization provided the research meets the criteria for waiver of authorization in 45 CFR 164.512(i)(2)(ii). This will permit VHA to use and disclose PHI outside of VHA for research purposes under the HIPAA Privacy Rule. As a reminder, when disclosing PHI outside of VHA for research purposes authority under the other applicable federal privacy laws is required in addition to the waiver.

Date Published: 2020-04-06

If my ORD-funded protocol just received approval and I am now ready to start, can I still begin if I received my ACOS/R&D letter to initiate the study?

Yes, if your study involves critical interactions as defined in the CRADO memorandum dated March 17, 2020, then:

a. Please ensure that you have adequate study staff and resources before you begin conducting the study.
b. Please consider delaying enrollment if your study procedures may be impacted by the pandemic.

Date Published: 2020-04-06

If I am permanently changing my study procedures as a result of the pandemic, is an amendment necessary?

Yes. If you are changing the conduct of the protocol permanently, please submit an amendment. This should be done in accordance with local IRBpolicies and procedures after initiating the change to eliminate immediatehazards to subject safety. If this is not a permanent change and only a temporary modification to eliminate immediate hazards to subject safety, an amendment is not required. If you are making changes to study procedures that are not related to eliminating immediate hazards to subject, an amendment is necessary

Date Published: 2020-04-06

If I am only changing my study procedures temporarily, to eliminate immediate hazards to subject safety, do I have to notify the IRB?

Yes. You must notify the IRB whenever you are making any change in the IRB-approved protocol. You do not have to wait to obtain IRB approval when making changes to eliminate immediate hazards to subject safety to implement those changes, but you must notify the IRB of the changes that were made, in the manner and timeframe required by written local policy. In addition, you must notify any other applicable parties or individuals if required. For example, if the protocol was an industry-sponsored clinical trial, and the protocol stated that any modifications in the IRB-approved protocol require notification to the sponsor, reporting to the sponsor is required.

Date Published: 2020-04-06

If my non-ORD sponsor notifies me that they are suspending the whole trial due to the pandemic, do I have to notify the IRB?

Yes. This represents a change in the IRB-approved research procedures of which the IRB must be informed. As required by VHA Directive 1058.01, Paragraph 6.i., the IRB must be notified, in writing, within 5 business days after becoming aware of any suspension or termination of VA research by, or at the direction of, any entity external to the facility

Date Published: 2020-04-06

Do I have to change my consent form or reconsent my subjects after I implement changes to eliminate immediate apparent hazards?

The IRB determines whether changes in the IRB-approved informed consent form or reconsenting of subjects is required. As part of the IRB approval criteria in 38 CFR§16.111(a)(4), the IRB is responsible for both the process and documentation of informed consent, including any revisions in either the process or documentation after the research is initially approved by an IRB. ORD wishes to reinforce that IRB approval is not required for an Investigator to implement changes to eliminate immediate hazards to subjects.

If the IRB determines that previously enrolled subjects and/or currently enrolled subjects require reconsenting, the IRB may require reconsenting or other means of conveying the information to the subjects, such as notifying the subjects by written communication or other forms of communication defined by the IRB and requiring the investigator to document when the communication occurred.

However, information is not to be withheld from subjects if changes are implemented immediately to eliminate apparent hazards to human subjects. For example, if an Investigator changed a study visit required for monitoring the safety of the subject at the Investigator’s VA Medical Center to a telephone study visit, the Investigator must inform the subject to not come to VA Medical Center and that monitoring will occur through a non-physical contact study visit; the Investigator does not need to wait for the IRB to evaluate whether an informed revision is necessary.

Date Published: 2020-04-06

Can an Investigator make a change in the IRB-approved method of documenting informed consent prior to obtaining IRB approval in order to eliminate immediate apparent hazards to human subjects?

No. The IRB has regulatory authority over both the process and documentation of informed consent in a non-exempt human subjects study as described in 38 CFR§16.111(a)(4). Any changes in how informed consent documentation is obtained must be approved prospectively by the IRB.

Date Published: 2020-04-06

How can written informed consent be obtained from VA research subjects who are in COVID-19 isolation?

ORD and ORO have consulted with other federal agencies, including the Office for Human Research Protections (OHRP) and FDA, on obtaining written informed consent from research subjects who are in COVID-19 isolation. As stated in FDA’s guidance released on March 20, 2020 and updated on March 27, 2020, ORD is in alignment with FDA’s guidance titled: FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic located: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

As referenced in FDA’s guidance, the following options are available to satisfy documentation requirements as approved by the IRB for written informed consent for patients in COVID-19 isolation who consent to be in VA research studies.

A. Electronic methods of obtaining consent

B. When it is not possible to obtain informed consent electronically, the following steps can be considered:

1. An unsigned consent form is provided to the patient by a heath care worker who has entered the room

2. If direct communication with the patient in isolation is not feasible or safe, the investigator or delegated research staff obtains the patient’s phone number and arranges a three-way call or video conference with:

a. the patient,
b. an impartial witness,
c. and if desired and feasible, additional participants requested by the patient, e.g. next of kin.


3. To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following:

a. Identification of who is on the call
b. Review of the informed consent with the patient by the investigator (or their designee) and response to any questions the patient may have
c. Confirmation by the witness that the patient’s questions have been answered
d. Confirmation by the investigator that the patient is willing to participate in the trial and sign the informed consent document while the witness is listening on the phone
e. Verbal confirmation by the patient that they would like to participate in the trial and that they have signed and dated the informed consent document that is in their possession.


If the signed informed consent document will not be able to be collected from the patient’s location and included in the study records, the following two options are acceptable to provide documentation that the patient signed the informed consent document:

Option #1: Attestations by the witness who participated in the call and by the investigator that the patient confirmed that they agreed to participate in the study and signed the informed consent,

Note: ORD recommends that the documented verbal confirmation include information on the version of the IRB-approved informed consent document that was used, such as IRB-approved informed consent dated 03/30/2020, Version 1.0, or other type of designation such as IRB-approved on 03/30/2020.

Option #2: A photograph of the informed consent document with attestation by the person entering the photograph into the study record that states how that photograph was obtained and that it is a photograph of the informed consent signed by the patient.

A copy of the informed consent document signed by the investigator and witness should be placed in the patient’s trial source documents, with a notation by the investigator of how the consent was obtained, e.g. telephone. The trial record at the investigational site should document how it was confirmed that the patient signed the consent form (i.e., either using attestation by the witness and investigator or the photograph of the signed consent). The note should include a statement of why the IC document signed by the patient was not retained, e.g., due to contamination of the document by infectious material.

If the patient is unable to provide informed consent and there is a legally authorized representative, investigators should obtain consent from the participant’s legally authorized representative if the IRB approved that informed consent could be obtained from the subject’s legally authorized representative

Date Published: 2020-04-06

How can written HIPAA authorization be obtained from VA research subjects who are in COVID-19 isolation?

As a response to the COVID-19 health pandemic, HHS Office of Civil Rights (OCR) is exercising enforcement exceptions that apply to health care provider activities beyond treatment and would cover research-related care or treatment, such as with clinical trials. Please note that HHS OCR guidance is not expanding or otherwise altering the HIPAA Privacy and Security Rules but simply provides that HHS OCR will use its enforcement discretion to not issue penalties for violations by covered entities responding to the COVID-19 public health emergency.

Research HIPAA Authorizations, VA Form 10-0493 may also obtained remotely by the following:

• Subject signs VAF 10-0493 at home and send to VHA via fax or take a digital image to send via MyHealtheVet secure messaging. ORD is not recommending instructing the subject to send back the signed document by mail. VHA accepts an image of a signed authorization the same as the original.

In addition, the IRB may approve to waive the HIPAA authorization requirement due to challenges of obtaining authorization during the COVID-19 crisis as outlined in Question#9 below.

Date Published: 2020-04-04

How do I remove my PPE to prevent possible contamination?

The order to remove is gloves, goggles or face shield, gown, mask or respirator. See the CDC guidance https://www.cdc.gov/hai/pdfs/ppe/PPE-Sequence.pdf

Date Published: 2020-04-04

What is the difference between BSL-1, 2 and 3 laboratories?

Document image included in Original FAQ

Date Published: 2020-04-04

How should the laboratory perform a risk assessment to identify and mitigate risks?

All laboratories should perform a site-specific and activity-specific risk assessment to identify and mitigate risks and determine if enhanced biosafety precautions are warranted based on situational needs, such as high testing volumes, and the likelihood to generate infectious droplets and aerosols. CDC has SARs-CoV-2 guidance/FAQ on this: https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html

Date Published: 2020-04-04

If my protocol requires me to collect specimens from either persons under investigation (PUI) or COVID+ subjects, what personal protective equipment (PPE) do I need to wear?

There is no difference in what healthcare professionals need as PPE from what a researcher needs as PPE when interacting with either a PUI or COVID+ patient/subject. See CDC guidance. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html#adhere

Date Published: 2020-04-04

What is the current recommended PPE for interacting with PUI or COVID+ patients/subjects?

Respirator or Facemask o Put on a respirator or facemask (e.g., surgical mask, procedure mask), if a respirator is not available) before entry into the patient room or care area. NOTE: A face mask (also called a surgical mask, procedure mask, or other similar terms) should not be confused with PPE for a worker; the mask acts to contain potentially infectious respiratory secretions at the source (i.e., the person’s nose and mouth).


• Eye Protection
o Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area. Personal eyeglasses and contact lenses are NOT considered adequate eye protection. Note: A face shield may be worn over goggles to protect exposed areas of the face but should not be worn as a primary form of eye protection
o Remove eye protection before leaving the patient room or care area.
o Reusable eye protection (e.g., goggles) must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use. Disposable eye protection should be discarded after use.


• Gloves
o Put on clean, non-sterile gloves (that fit snuggly over the gown cuff )upon entry into the patient room or care area.
Change gloves if they become torn or heavily contaminated.
o Remove and discard gloves when leaving the patient room or care area, and immediately perform hand hygiene.


• Gowns
o Put on a clean isolation gown (preferably with fluid-resistant properties) upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Cloth gowns should be laundered after each use.

Date Published: 2020-04-04

If my protocol requires me to collect a nasopharyngeal swab, what precautions should I take?

You should wear an N-95 or higher-level respirator, e.g., a powered air purifying respirator (PAPR) with high-efficiency particulate arrestance (HEPA) filter, R/P95, N/R/P99, or N/R/P100 filtering facepiece respirator; an air-purifying elastomeric (e.g., half-face or full-face) respirator with appropriate filters or cartridges (or facemask if a respirator is not available), eye protection, gloves, and a gown. Face shields may also be worn on top of a respirator to prevent bulk contamination of the respirator. Those present should be limited to only those essential for patient care and procedure support. Visitors should not be present for the procedure. Visitors should not be present for specimen collection. Specimen collection should be performed in a normal examination room with the door closed. Clean and disinfect procedure room surfaces promptly.

Date Published: 2020-04-04

What is an aerosol generating procedure (AGP)?

Both clinical and laboratory procedures can result in aerosol generation. A procedure that is likely to induce coughing (e.g., sputum induction, open suctioning of airways) is such a clinical procedure. These should be performed cautiously and avoided if possible. See FAQ #14 in the source document for a list of common laboratory procedures that can generate aerosols.

Date Published: 2020-04-04

If my protocol requires an aerosol generating procedure, are there different precautions?

Both clinical and laboratory procedures can result in aerosol generation.

For clinical procedures, you should wear an N95 or higher-level respirator, eye protection, gloves, and a gown. You should limit the number of personnel in the room during the procedure. Those present should be limited to only those essential for patient care and procedure support. Visitors should not be present for the procedure. AGPs should ideally take place in an airborne infection isolation room (AIIR). Clean and disinfect all procedure room surfaces promptly.

For laboratory procedures, , you should wear an N95 or higher-level respirator, eye protection, gloves, and a gown. You should limit the number of personnel in the room during the procedure. All work with infectious materials that can form aerosols or splashes are performed within a biological safety cabinet (BSC). NOTE: Per CDC guidance, procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Type A1 or A2 BSC or additional precautions to provide a barrier between the specimen and personnel.

https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html

Date Published: 2020-04-04

What constitutes an Airborne Infection Isolation Room (AIIR)?

AIIRs are single-patient rooms at negative pressure relative to the surrounding areas, and with a minimum of 6 air changes per hour (12 air changes per hour are recommended for new construction or renovation). Air from these rooms should be exhausted directly to the outside or be filtered through a high-efficiency particulate air (HEPA) filter directly before recirculation. Room doors should be kept closed except when entering or leaving the room, and entry and exit should be minimized. Facilities should monitor and document the proper negative-pressure function of these rooms.

Date Published: 2020-04-04

What disinfectants have been approved for use against COVID-19?

Please see this EPA list: https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2

Date Published: 2020-04-04

What is the recommended biosafety level for handling suspected or confirmed SARS-CoV-2 research specimens?

Routine diagnostic testing of patient specimens, such as the following activities, can be handled in a BSL-2 laboratory using Standard Precautions: Note: any manipulations of potentially infectious samples that have the potential to generate aerosols (see #14 below) should be performed in a biological safety cabinet.

Using automated instruments and analyzers
• Staining and microscopic analysis of fixed smears
• Examination of bacterial cultures
• Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues
• Molecular analysis of extracted nucleic acid preparations
• Final packaging of specimens for transport to diagnostic laboratories for additional testing. Specimens should already be in a sealed, decontaminated primary container
• Using inactivated specimens, such as specimens in nucleic acid extraction buffer
• Electron microscopic studies with glutaraldehyde-fixed grids


NOTE: A site-specific risk assessment should be performed to determine if enhanced biosafety precautions, such as those consistent with BSL-3, are warranted based on situational needs (e.g. high testing volumes), including when:

Aliquoting and/or diluting specimens
Inoculating bacterial or mycological culture media
Performing diagnostic tests that do not involve propagation of viral agents in vitro or in vivo
Nucleic acid extraction procedures involving potentially infected specimens
Preparation and chemical- or heat-fixing of smears for microscopic analysis

Date Published: 2020-04-04

How should suspected or confirmed SARS-COV-2 specimens be stored?

Store specimens at 2-8oC for up to 72 hours after collection. If a delay occurs in extraction, store specimens at -70oC or lower. Store extracted nucleic acid samples at -70oC or lower.

Date Published: 2020-04-04

How should laboratory personnel remove biohazardous waste from the laboratory or testing area for decontamination and disposal?

Handle laboratory waste from testing suspected or confirmed COVID-19 patient specimens as all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that this laboratory waste needs additional packaging or disinfection procedures.

Date Published: 2020-04-04

How should personnel transport suspected or confirmed SARS CoV-2 specimens within a facility?

Personnel should adhere to standard procedures associated with other respiratory pathogens, such as seasonal influenza and other human coronaviruses, when they transport specimens within a facility. Personnel should perform site- and activity-specific risk assessments to determine if enhanced biosafety precautions are warranted based on situational needs.

Date Published: 2020-04-04

What are Standard Precautions?

Standard Precautions are based on the principle that all blood, body fluids, secretions, nonintact skin, mucous membranes, and excretions (except sweat) may contain transmissible infectious agents. Standard Precautions include hand hygiene and the use of personal protective equipment (PPE) such as laboratory coats or gowns, gloves, and eye protection. Standard precautions also include safe waste management as well as cleaning and disinfection of surfaces and equipment.

Date Published: 2020-04-04

What laboratory procedures can generate aerosols and droplets?

Many routine laboratory procedures can potentially generate aerosols and droplets that are often undetectable. The following laboratory procedures have been associated with the generation of infectious aerosols and droplets: centrifugation, pipetting, vortexing, mixing, shaking, sonicating, removing caps, decanting liquids, preparing smears, flaming slides, aliquoting and loading specimens, loading syringes, manipulating needles, syringes or sharps, aspirating and transferring blood and body fluids, sub-culturing blood culture bottles, spilling specimens, and cleaning up spills.

Date Published: 2020-04-04

What are infectious aerosols and droplets?

Aerosols and droplets containing particles that are <100 μm in diameter are not visible to the naked eye. Laboratory workers may not be aware that such particles can be generated during many laboratory procedures and that these particles could be inhaled or could cross-contaminate work surfaces, materials, and equipment.

Date Published: 2020-04-04

Do people packing patient specimens, isolates or cultures for transport need to be trained and competent?

For transporting patient specimens, cultures or isolates, personnel must be trained in the proper safety, packing, and shipping regulations for Division 6.2, UN 3373 Biological Substance, Category B in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations (DGR). Personnel should be trained in a manner that corresponds to their function-specific responsibilities.

For additional information, refer to the following: Guidance on regulations for the transport of infectious substances 2019 – 2020 https://www.who.int/ihr/publications/WHO-WHE-CPI-2019.20/en/

Date Published: 2020-04-04

What specific packaging should personnel use when shipping suspected or confirmed SARS-CoV-2 patient specimens, isolates or cultures?

Pack and ship suspected or confirmed SARS-CoV-2 patient specimens, cultures or isolates as UN 3373 Biological Substance, Category B, in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations (DGR)

1. A leakproof primary container.
2. A leakproof, watertight secondary packaging with absorbent material (sufficient to absorb the volume of liquid in the primary container).
3. A rigid outer packaging to protect the specimens during shipment.

Date Published: 2020-04-04

What is a Category B substance?

Infectious substances are subclassified as Category B when they contain biological agents capable of causing infection in humans or animals, but NOT meeting the criteria for Category A; that is, the consequences of an infection are not considered severely disabling or life-threatening. See WHO guidance for more details. https://apps.who.int/iris/bitstream/handle/10665/325884/WHO-WHE-CPI-2019.20-eng.pdf?ua=1

Date Published: 2020-04-04

At what temperature should specimens be shipped?

Specimens should be shipped at 2-8oC with ice packs. If the specimen is frozen, ship overnight on dry ice. The primary receptacle and the secondary packaging should maintain their integrity at the temperature of the refrigerant used as well as the temperatures and the pressures which could result if refrigeration were lost. Packages containing dry ice should be designed and constructed so as to prevent the buildup of pressure and to allow the release of gas that could rupture the packaging.

Date Published: 2020-04-04

If I have additional questions about shipping specimens, where can I find information?

For labeling and specific shipping instructions see CDC guidance: https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html

Date Published: 2020-04-04

If I am doing COVID-19 virus isolation work, what type of laboratory must I be in?

Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of SARS-CoV-2 specimens should only be conducted in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices. Site- and activity-specific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs.

Date Published: 2020-04-04

If I am doing a project with my University affiliate, may I walk the specimens over or put the packaged COVID-19 biospecimens in my car and drive them over to the affiliate?

No. Specimens must be handled in accordance with standard transfer methods between the institutions, as you would with a clinical specimen.

Date Published: 2020-04-04

What should I do in case of a biological spill or exposure during my research study?

Prior to initiating research with coronavirus, you should prepare a biological spill kit. Laboratories engaged in research with any infectious agents should have a spill kit that contains, at a minimum, the following:

Disposable absorbent material (e.g., paper towels and absorbent pads/granules)
• EPA approved disinfectant such as 70% ethanol or 10% household bleach. Note: bleach should be made fresh periodically. For comprehensive a list of EPA registered disinfectants that can be used for coronavirus, see: https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2
• Biohazard bags (autoclavable)
• Disposable broom & dustpan, small brush with handle
• Tongs/forceps
• PPE (e.g., gloves, gown/coverall, safety glasses, face shield, shoe or boot covers, respirator (for instances when spill occurred outside biosafety cabinet)) – change regularly to ensure integrity of materials
• Laminated clean-up procedure card


You should also consult your local facility safety staff and policies for advice and guidance. All biological spills, regardless of scale or exposure potential need to be reported to the Lab Supervisor or Principal Investigator (PI). All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials.

In general, small spills that result in minimal contamination of the work area can be safe managed by laboratory staff. Laboratory personnel can clean up small quantities of known material if they are familiar with the associated hazards, have appropriate personal protective equipment, and are trained in spill-cleanup procedures. Spills involving large volumes of infectious material or that result in significant contamination of the laboratory will likely need to be addressed in conjunction with facility safety staff. Additionally, biological spills outside of primary containment (i.e., a biological safety cabinet) raise additional concerns including pathogen aerosolization, the potential splash of mucous membranes during spill/spill cleanup, how far the contamination spread, etc. Biological spills outside biological safety cabinets can generate aerosols that can be dispersed in the air throughout the laboratory.

The first rule of a spill response is: DON’T MAKE IT WORSE

In other words, don’t panic, remain calm, and think through your next steps. Do not take any actions that will spread contamination beyond the immediate area of the spill. For example, spills on the floor can easily be spread to other areas through contamination of shoes. Spills frequently create a potential for biological exposures; however, if you are wearing appropriate PPE, your likelihood of an exposure will be reduced.

General recommendations for any biological spill response include:

1. Notify others working in the area of the hazard.
2. If this is a large spill or if you have sustained significant contamination to your PPE or shoes, take no additional action; ask someone to notify facility safety staff and wait for assistance to arrive.
3. If the spill is small (e.g., a few milliliters and confined to the benchtop or biological safety cabinet) and your PPE was not contaminated, retrieve the spill kit.
4. If any broken glass is present use forceps or tongs to place pieces into a disposable, puncture resistant biohazard container.
5. Cover the spill area with absorbent materials.
6. Apply disinfectant* onto the absorbent material to saturate the contaminated area and wait appropriate contact time. Sufficient contact time is critical for the disinfection process; follow manufacturers recommendations for contact time. Note: the presence of organic material (e.g. sputum) can slow the disinfection process, and thus contact time may need to be increased in spills containing organic material.
7. Carefully remove disinfectant saturated absorbent material and place into the biohazard bag for disposal.
8. Repeat steps 5, 6, & 7 one time.
9. When the spill is addressed, remove and properly dispose of PPE.
10. Wash your hands with soap and water immediately.
11. Notify facility safety staff, occupational/employee health**, and the SRS of the incident.
12. Restock the kit for next use. (See kit contents list on reverse side of card)


*For infectious agents, such as coronavirus, that are easily aerosolized, carefully pouring the disinfectant over the area is preferable to use of a spray bottle.

**Remember that although spills create a risk of exposure, appropriate use of proper PPE is your best defense in the event of an unexpected incident. However, it is still important to alert facility occupational/employee health of the incident as they may recommend testing/monitoring in accordance with established medical guidelines.

Date Published: 2020-04-04

What if I have an unprotected exposure? What should I do?

If you have an unprotected exposure (i.e., not wearing recommended PPE, or exposure despite PPE) to a confirmed or possible COVID-19 patient or specimen, contact your supervisor or occupational health immediately. Follow any local policies that are in place for exposures, Because a cough or sneeze from a known or suspected positive COVID-19 patient could result in contamination of your skin, clothing, and/or PPE; use caution not to spread contamination to other individual, to surfaces, or to other areas; if possible have a person who was not impacted notify facility safety and occupation health and wait for assistance.

Date Published: 2020-04-04

What is the difference between a surgical mask and N95 respirator?

A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. These are often referred to as face masks, although not all face masks are regulated as surgical masks. Note that the edges of the mask are not designed to form a seal around the nose and mouth.

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s.

See CDC infographic https://www.cdc.gov/niosh/npptl/pdfs/UnderstandDifferenceInfographic-508.pdf

Date Published: 2020-04-04

Can an N95 respirator be re-used?

Yes. If reuse of N95 respirators is permitted at your laboratory or medical facility, respiratory protection program administrators should ensure adherence to administrative and engineering controls to limit potential N95 respirator surface contamination (e.g., use of barriers to prevent droplet spray contamination) and consider additional training and/or reminders (e.g., posters) for staff to reinforce the need to minimize unnecessary contact with the respirator surface, strict adherence to hand hygiene practices, and proper PPE donning and doffing technique, including physical inspection and performing a user seal check.(16) Healthcare facilities should develop clearly written procedures to advise staff to take the following steps to reduce contact transmission:

• Discard N95 respirators following use during aerosol generating procedures.
• Discard N95 respirators contaminated with blood, respiratory or nasal secretions, or other bodily fluids from patients.
Discard N95 respirators following close contact with any patient co-infected with an infectious disease requiring contact precautions.
• Consider use of a cleanable face shield (preferred3) over an N95 respirator and/or other steps (e.g., masking patients, use of engineering controls), when feasible to reduce surface contamination of the respirator.
• Hang used respirators in a designated storage area or keep them in a clean, breathable container such as a paper bag between uses. To minimize potential cross-contamination, store respirators so that they do not touch each other and the person using the respirator is clearly identified. Storage containers should be disposed of or cleaned regularly.
• Clean hands with soap and water or an alcohol-based hand sanitizer before and after touching or adjusting the respirator (if necessary, for comfort or to maintain fit).
• Avoid touching the inside of the respirator. If inadvertent contact is made with the inside of the respirator, discard the respirator and perform hand hygiene as described above.
• Use a pair of clean (non-sterile) gloves when donning a used N95 respirator and performing a user seal check. Discard gloves after the N95 respirator is donned and any adjustments are made to ensure the respirator is sitting comfortably on your face with a good seal.

Date Published: 2020-03-12

How soon after IRB approval must a protocol or informed consent revision be carried out by the research team?

Although changes in approved research require IRB approval, neither the Common Rule (38 CFR Part 16) nor VHA Handbook 1200.05 specifically stipulates how quickly an IRB must communicate its approval of changes to the investigator or how quickly the investigator must carry out the approved changes. The safety of the research subjects should be of primary concern in this regard. Safety concerns related to the timely implementation of IRB-approved changes should be brought to the attention of the IRB. Where warranted to ensure subject safety, IRBs may stipulate that the approved changes must be implemented prior to the enrollment of new subjects and/or that previously enrolled subjects must be informed of the changes. In such circumstances, the IRB has an obligation to provide the investigator with timely notification sufficient to address the safety issues involved.

Date Published: 2020-03-12

Must the revised informed consent form be employed at the same time by all sites involved in a multi-site research project?

No. If multiple IRBs are involved, it is unlikely that they will all approve the document at the same time. Even if a single IRB (e.g., the VA Central IRB) is involved, release of approval letters for dozens of sites at the same time may not be practical because the forms may need to be individualized for the specific sites. (Original Post Date: March 12, 2012)

Date Published: 2020-03-12

Must expiration dates appear on informed consent forms for VA research?

No. Neither the Common Rule (38 CFR Part 16) nor VHA Handbook 1200.05 requires that expiration dates appear on informed consent forms. Each IRB has the authority to determine whether or not expiration dates are to appear on the consent forms that it approves.

Date Published: 2020-03-12

Can VA Associate Chiefs of Staff (ACOSs) for Research and Development (R&D), VA Administrative Officers (AOs) for R&D, VA research office staff, VA IRB administrators, or VA IRB administrative staff serve as voting members or alternate voting members of a VA facility’s local IRB of record?

No. VA ACOSs for R&D, VA AOs for R&D, VA research office staff, VA IRB administrators, and VA IRB administrative staff cannot serve as voting members or alternate voting members of a VA facility’s local IRB of record, whether that IRB is an internal VA IRB, the IRB of another VA facility, or an affiliate IRB.

Date Published: 2020-03-12

Can affiliate administrative staff, including affiliate IRB administrative staff, serve as voting members or alternate voting members of an affiliate IRB serving as a VA facility’s IRB of record?

Yes. VHA policy cannot address this issue. The affiliate IRB has the authority to decide whether or not to allow affiliate administrative staff to serve as voting members or alternate voting members of the affiliate IRB, even when it serves as the IRB of record for a VA facility.

Date Published: 2020-03-10

In response to VHA medical centers implementing clinical screening procedures for COVID-19 infection and questions about modifying study procedures as a result of concerns about Covid-19, ORD has been asked whether the addition of these clinical screening procedures require amending VA research protocols. ORD is providing the following clarifications to VA researchers:

New mandatory VHA clinical screening procedures are not considered part of the“IRB approved procedures” for your protocol and therefore do not necessarilytrigger the need for an amendment to the protocol. These screening procedures do not constitute a change in IRB-approved research procedures unless youchoose to incorporate the data collected under the mandatory screening into yourstudy plan as part of the research, such as adding a research objective ofanalyzing the results of the clinical screening procedures based on subjectdemographics.

Any changes in IRB-approved research procedures must be reported to the IRBand may not be implemented prior to review and approval by the IRB exceptwhen necessary to eliminate apparent immediate hazards to the subject. This ispermitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and FDAregulations (21 CFR §56.108(a)(4)) in order to prevent investigators fromdelaying the initiation of safety changes to eliminate apparent immediate hazardsto subjects. Beyond the regulation, VA also has a responsibility to ensure thesafety of its staff. As such, interim measures to eliminate immediate hazards tostaff, which may involve deviating from approved study procedures prior tosecuring IRB approval, may be warranted.

•Examples of modifications or safety changes include, but are not limited to,cancelling non-essential study visits, conducting phone visits in lieu of in-personvisits, conducting safety screening (initiated by the Principal Investigator) prior toin-person visits occurring, or other changes as deemed appropriate to eliminateimmediate hazards to subjects because of the risk of exposure to this highlycommunicable disease.

If it is anticipated that immediate changes made to the study to eliminate apparent immediate hazards will be sustained for a duration that would practicably allow for an amendment to cover such changes to be developed by an investigator and reviewed and approved, as appropriate, by the IRB, then approval of a protocol amendment must be sought.

In some cases, these protocol changes may involve the Principal Investigator temporarily stopping subject recruitment or placing a temporary hold on all study procedures. Principal Investigators are encouraged to communicate with the applicable funding agency or sponsor as needed prior to initiating modifications to IRB approved protocols without IRB approval.

For awareness, ORD is in the process of coordinating new research activities on COVID-19 as part of the larger national response being conducted by VA/VHA and other Federal agencies. Information will be provided separately on such activities. If an investigator is interested in initiating a new study protocol involving COVID-19 and/or who may have information that could be helpful for future research on this topic, please notify Dr. Vicky Davey (Victoria.davey@va.gov) and/or Dr. Jane Battles (jane.battles@va.gov) in ORD.

Date Published: 2020-03-03

Will smart forms, fillable forms, and letter templates be made available to the sites that transition to VA’s instance of IRBNet?

VAIRRS includes two wizards: The Project Cover Sheet and the IRB Information Sheet. The Project Cover Sheet is required for all submissions. The IRB Information Sheet is required for all submissions to the IRB (internal and external). A continuing review form, closure report, and IACUC information sheet will all be developed within the coming months. ORPP&E, along with a field-based workgroup, has developed a core library of form and letter templates for each of the committee and subcommittee workspaces in VAIRRS. You may preview the core library on the VAIRRS SharePoint portal.

Date Published: 2020-03-03

Will IRBNet update the station's ePROMISE records?

Currently the system does not integrate with ePROMISE. We hope to integrate VAIRSS with other ORD enterprise systems in the near future.

Date Published: 2020-03-03

Is there an instruction manual that can be distributed for researchers and/or administrators?

IRBNet is an intuitive, web-based tool that has instruction and help text available at various places throughout the application. A full library of training energizers for the researchers, committee administrators and reviewers are available for download from the VAIRRS SharePoint portal.

Date Published: 2020-03-03

Will each institution have their own specific templates for their forms?

ORPP&E, along with a field-based workgroup, has developed a core library of form and letter templates for each of the committee and subcommittee workspaces in IRBNet. However, IRBNet supports the ability for you to upload your own supplemental forms (such as if a particular form or template is required to support state or local regulations) via the Library Manager.

Date Published: 2020-03-03

Does ORPP&E have guidance on how each of the smart form questions should be answered?

ORPP&E designed the smart forms to be as straightforward as possible. In most cases, the researchers only have to answer simple "Yes" or "No" questions. ORPP&E reviews all feedback on the smart forms from the research community. If a question seems to be producing inconsistent answers or is causing confusion among your researchers, please email the project team at VAIRRS@VA.gov.

Date Published: 2020-03-03

Our site has installed the "Skype for Business" add-on for Internet Explorer. Can we use this add-on with IRBNet?

There is a known issue with the "Skype for Business" add-on for Internet Explorer that affects users who create rich-text content that includes phone numbers. In IRBNet, this primarily affects administrative users who draft decision letters in the rich-text editor. Microsoft has not yet released an update to address this issue. If possible, we recommend that staff who edit letters disable the add-on or use an alternate browser.

Date Published: 2020-03-03

Does IRBNet link to TMS/CITI?

Yes, IRBNet supports the integration of TMS and CITI so that records can be automatically created for users who link their IRBNet accounts to TMS or CITI. TMS Integration is not yet available.

Date Published: 2020-03-03

Should the OGE Form 450 Alternative VA be submitted through IRBNet?

No, the OGE 450 Alt VA should not be uploaded into IRBNet. ORPPE has requested that the researcher submit the OGE 450 Alt VA outside of IRBNet. If the COI review is complete, the researcher may attach the findings to their package.

Date Published: 2020-03-03

Can you tell us more about the impetus for the Feasibility, Alignment, and Scientific review (FASR) checklist?

We were asked to separate the Feasibility and Alignment assessment from the Scientific assessment since many projects come with a scientific review. The form was created because so many of our facilities were not assessing feasibility until the end of the study, if at all. After thousands of dollars of review time by committees, R&D committees were then challenging if the study could be done or altering the study causing amendments to be filed with other committees, using even more committee time. Ultimately, the perceived non-completion rate, especially of investigator-initiated studies, was the impetus. The burden on the research staff and committees for review of projects that are not feasible or scientifically invalid are large and take time away from studies that are feasible and scientifically valid.

Date Published: 2020-03-03

If the project does not meet the definition of research does the FA or SR evaluation stop?

Yes, the research service is not responsible for projects that do not meet the definition of research, unless your facility is requiring your review. The quality office is responsible for projects that involve quality improvement/assurance or evidence-based practice, etc.

Date Published: 2020-03-03

Can the FASR reviewer checklists be completed after submission to sub-committees or is the expectation that R&D provides this review first and then repeat the eval after approval from the other committee?

The review needs to be completed by someone (not necessarily an R&D members, though they likely have the best grasp of the projects happening across the facility) who can assess whether the project can be accomplished in the proposed time frame, by the provider submitting it, and if it will interfere with other studies happening at the facility. A statement from the investigator’s supervisor stating he/she has the time to conduct the project and is qualified to conduct the project would go a long way in helping the person reviewing the form. The review is intended to be done before it is assigned to any committee for review as to reduce burden on the committees of studies that are not feasible or scientifically valid.

Date Published: 2019-10-25

What is Azure Rights Management Services?

Azure Rights Management System (often abbreviated to Azure RMS) is the protective technology used by Azure Information Protection. It uses encryption, identity, and authorization policies to help secure file attachments and email. Information can be protected both within the VA and outside the VA because the protections remain with the data, even when it leaves the VA. VA OI&T has issued a set of Frequently asked questions (FAQs) about Azure RMS located at https://vaww.portal2.va.gov/sites/AIP/_layouts/15/WopiFrame.aspx?sourcedoc=/sites/AIP/Shared%20Documents/Azure%20RMS%20Frequently%20Asked%20Questions.docx&action=default

Date Published: 2019-10-25

Can Azure RMS be used by VA researchers to send large data files to another researcher?

Azure RMS can transfer files up to 40Mb.

Date Published: 2019-10-25

Can Azure RMS be used by VA researchers to communicate personally identifiable information and protected health information (PII/PHI) to VA subjects?

Yes. Azure RMS can be used to communicate PII/PHI to VA subjects as part of the approved VA research protocol. External Recipients can open or view RMS encrypted email from any compatible web browser or through their social email account (Gmail, Yahoo, Outlook).

Date Published: 2019-10-25

Can Azure RMS be used by VA researchers to send a secure email to a research collaborator?

Yes. Azure RMS can be used to send a secure email to a research collaborator as part of the approved VA research protocol. Azure RMS provides encryption through email for compliance with Federal Information Protection Standards (FIPS) 140-2 and other VA Sensitive Information (VASI) compliance requirements. Official VA Research communication must be initiated through a VA Outlook account using VA OI&T approved Azure RMS Procedures.

Date Published: 2019-10-25

What are some considerations for an IRB or VA R&D Committee evaluating a research study proposing to utilize Azure RMS to recruit or communicate messages containing PII/PHI with VA subjects?

Both exempt and non-exempt human subjects studies may be conducted using Azure RMS to recruit or communicate messages containing PII/PHI with VA subjects. The use of Azure RMS is analogous to any method of communication used in human subjects research; its use must be evaluated by the applicable research oversight committee(s). If standardized communications are used, the applicable research oversight committee must review the content of standardized communications. Other considerations for the use of Azure RMS to recruit or communicate messages containing PII/PHI include, but are not limited to, the following:

IRBs and/or R&D Committees must review and approve all aspects of recruitment, including the specific methodologies used and the text of recruitment letters or email.

IRBs and/or R&D Committees should consider prospective subjects’ confidentiality issues when Azure RMS is used for recruitment in VA research. Unless the prospective subjects have already given their prior consent, permission, or opted in to receive information by email about possible research opportunities, the prospective subjects are receiving unsolicited emails. Similar to IRB considerations for contacting prospective subjects by physical mail, the IRB and/or R&D Committee should also consider how many emails are sent to prospective subjects for recruitment purposes. The IRB and/or R&D Committee should also evaluate whether the frequency and/or content could be considered to be coercive or harassment by prospective subjects.

ORD recommends that reviewing IRBs and/or R&D Committees evaluate information on the source of the email addresses to help ensure the privacy of prospective subjects when Azure RMS is used to send emails for the purpose of recruiting subjects in VA research. Use of Azure RMS is not the same as use of a Personal Identity Verification (PIV) card. Identity verification is not a component of Azure RMS. If Azure RMS is used to recruit VA subjects, it is important to use due diligence to determine the correct email addresses, similar to determining the correct address when mailing physical letters. This is important when using Azure RMS to send recruitment emails to minimize risk of sending sensitive information to unintended email recipients and protecting the privacy of subjects.

ORD recommends that IRBs and/or R&D Committees evaluate whether the use of Azure RMS is appropriate to communicate about some diagnoses or behaviors. While Azure RMS can be used to communicate PII/PHI, the IRB and/or R&D Committee should consider whether the use of email is appropriate for the type of communication with the VA subject.

Subjects may not know how to reply to an Azure RMS protected message. Investigators utilizing Azure RMS for recruiting or communicating purposes should consider whether they need to provide a user guide for subjects detailing the proper procedures for replying to an Azure RMS protected message. Any study-specific information materials provided to subjects must be approved by the IRB for research requiring IRB approval. For exempt research, information material provided to subjects must be approved by the R&D Committee if it is the sole oversight committee of the research activity.

Date Published: 2019-10-25

What are some considerations for VA Investigators proposing to utilize Azure RMS to send a secure email to a research collaborator?

The use of Azure RMS is analogous to any method of communication used in human subjects research; its use must be evaluated by the applicable research oversight committee(s).

Although emails encrypted with Azure RMS and their attached content will be encrypted while in transit, there are limitations with ensuring file encryption will remain with certain file types once the email is opened and the content/attachment is saved to the recipient’s desktop. ORD recommends that IRBs and/or R&D Committees evaluate whether the use of Azure RMS is appropriate to enforce VA security requirements beyond ensuring the email content is encrypted while in transit.

Research collaborators may not know how to reply to an Azure RMS protected message. VA Investigators may need to provide a user guide for research collaborators detailing the proper procedures for replying to an Azure RMS protected message.

Date Published: 2019-10-25

For VA research requiring a written informed consent document, is the IRB required to include specific language about use of Azure RMS?

ORD does not have a policy requiring that Azure RMS must be described in the written informed consent approved by an IRB. However, the IRB has authority to determine the content of informed consent to ensure that it is in accordance with, and to the extent required by 38 CFR 16.116. The Common Rule (e.g., the Federal Policy for the Protection of Human Subjects codified by VA as 38 CFR Part 16) requires as part of the basic elements of informed consent in 38 CFR Part 16.116(b)(1) that the following be provided to each subject or the subject’s legally authorized representative:

“A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental.”

The IRB has the responsibility for determining what must be in the informed consent document as part of the IRB approval criteria for research in 38 CFR 16.111, including the consent needed to ensure that prospective subjects or their legally authorized representatives are given sufficient information to make an informed decision whether to participate in the research. As part of its evaluation, the IRB evaluates what level of detail is needed about the description of procedures to be followed, such as methods used to communicate with subjects.

Date Published: 2019-09-27

Are Certificates of Confidentiality currently required for all federally funded studies involving the use or collection of identifiable, sensitive information, including any studies funded by VA?

Section 2012 of the 21st Century Act (42 U.S.C. 241) generally requires any federally funded research study that involves the use or collection of identifiable, sensitive information as defined by the Act to have a Certificate of Confidentiality. The National Institute of Health (NIH), one of the Federal agencies with authority to approve and issue Certificates of Confidentiality, issued a policy (NOT-OD-17-109) on September 7, 2017 titled Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality. Effective October 1, 2017, Certificates of Confidentiality will be issued automatically for any NIH-funded project using identifiable, sensitive information that was on-going on or after December 13, 2016. As part of the NIH policy, the NIH-funded studies using or collecting identifiable, sensitive information are issued Certificates of Confidentiality as a term and condition of the awards. No physical/electronic certificates are issued.

All Federal agencies and departments do not have the authority to issue Certificates of Confidentiality. VA, as well as other non-Department of Health and Human Services (HHS) agencies, does not have the authority to issue Certificates of Confidentiality. There is no HHS or ORD requirement for all VA-funded studies involving collection of identifiable, sensitive information to obtain a Certificate of Confidentiality at the present time. HHS has not yet developed a mechanism to allow VA to issue Certificates of Confidentiality or a mechanism for VA to implement a policy analogous to the NIH for automatic issuing of Certificates of Confidentiality for all VA-funded studies using or collecting identifiable, sensitive information. If a VA researcher wishes to request a Certificate of Confidentiality for a VA study, the VA researcher can request a Certificate of Confidentiality from NIH for health-related studies that are not funded by NIH. Application instructions are located at https://grants.nih.gov/policy/humansubjects/coc/how-to-apply.htm. Approval of Certificate of Confidentiality requests is at the discretion of the NIH.

Date Published: 2019-09-27

If a VA Investigator wants to obtain a Certificate of Confidentiality for a VA study, does ORD require subjects to be informed in the IRB-approved written informed consent document?

Yes. ORD policy in VHA Directive 1200.01, Paragraph 22(c) requires that the informed consent document approved by the IRB include a statement that the study has a Certificate of Confidentiality. For studies in which information about the subject’s participation will be included in the VA subject’s VHA medical record, information must also be given to the prospective subjects as part of the informed consent process that information regarding study participation will be included in the VHA medical record.

Date Published: 2019-09-20

Does the R&D Committee use the date subcommittee minutes are signed or the date subcommittee minutes are received to determine when a subcommittee finalizes minutes for purposes of the R&D Committee conducting its review of those minutes within 60 days?

ORD policy does not define what date must be used. ORD requires that the R&D Committee review subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes (VHA Directive 1200.01, Paragraph 8.a.(3)). Some subcommittee minutes require approval and signature, such as the Institutional Animal Care and Use Committee (IACUC) as described in VHA Handbook 1200.07, Paragraph 8.h.(2). Other subcommittee minutes, such as the IRB, do not unless there is a local applicable policy. Subcommittee policies and procedures should define how minutes are finalized.

The R&D Committee as part of its operations must maintain standard operating procedures or other written procedures for all recurring processes (VHA Directive 1200.01, Paragraph 6.e.). ORD recommends that the R&D Committee’s written procedures include a statement(s) defining how the R&D Committee determines when subcommittee minutes are finalized for purposes of conducting the ORD required review of subcommittee minutes within 60 days. The following, which does not represent an all-inclusive list, are two examples of sample language defining how the R&D Committee determines the date of subcommittee finalization of minutes:

(1) If date of subcommittee signature is used to define finalization of the minutes:
The convened R&D Committee must review subcommittee minutes within 60 days after the subcommittee minutes are signed. Subcommittee minutes are considered final as of the date of signature.

(2) If date of receipt by the R&D Committee is used to define finalization of the minutes.


The convened R&D Committee must review subcommittee minutes within 60 days after they are received physically or electronically, or notification is received that the subcommittee minutes are available for review. Subcommittee minutes are considered final as of that date.

Date Published: 2019-09-20

If the R&D Committee approves the inclusion of non-Veterans in an ORD-funded study, does it replace any required approvals or waivers for inclusion of non-Veterans by the ORD funding service?

No. R&D committee approval of inclusion of non-Veterans in an ORD-funded study does not replace any requirements of the applicable funding service.

Date Published: 2019-08-07

Which committee is responsible for reportable events involving Exempt human subjects research?

For an event otherwise required by VHA Handbook 1058.01, §6 to be reported to an IRB and that is associated with exempt human subjects research that falls under the oversight of a committee other than an IRB, the event shall be reported instead to the committee with primary oversight responsibility for the research (e.g., Research & Development Committee (R&DC), R&DC designated subcommittee for the oversight of exempt human subjects research, etc.). Under the aforementioned circumstances, responsibilities ascribed by VHA Handbook 1058.01, §6 to the IRB for reviewing or otherwise acting upon such events shall instead be carried out by the committee with primary oversight responsibility for the research.

Date Published: 2019-06-05

What are the quality assurance and quality improvement activities the Office of Research and Development (ORD) requires the R&D Committee to conduct as part of its review of research related committees and subcommittees as stated in VHA Directive 1200.01, Paragraph 6.f.: “The R&D Committee reviews all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities. . . .”?

ORD does not prescribe the specific number or types of quality assurance and quality improvement activities that the R&D Committee uses for its periodic review (at least annually) of its research-related committees and subcommittees. The R&D Committee has discretion to select the quality indicators or quality measures it considers most meaningful to its review. Possibilities include, but are not limited to:

a. Comparison of VA studies approved by the research-related committee or subcommittee against the VA studies approved by the R&D Committee to ensure that all studies approved by a research- related committee or subcommittee to be conducted as VA research are approved by the R&D Committee;
b. Attendance of subcommittee or committee members;
c. Documentation in the minutes of information specified by regulatory requirements, such as attendance and voting;
d. Length of time required for the committee or subcommittee to review and approve modifications to previously approved research;
e. Number of actions taken by the committee or subcommittee during a convened meeting, and the duration of the meeting; and
f. Reviewing a subset of standard operating policies of its research- related committees and subcommittees to evaluate whether documentation reflects implementation of the reviewed standard operating policies.

Date Published: 2019-06-05

Why is the R&D Committee required to review and approve recruitment of non-Veterans in VA research instead of an Institutional Review Board (IRB)?

VA research focuses on health issues that affect Veterans. A Veteran as defined in 38 U.S. Code §101(2) “. . . means a person who served in the active military, naval, or air service, and who was discharged or released therefrom under conditions other than dishonorable.” The R&D Committee is responsible for ensuring that all research in which the facility is engaged is consistent with the VA mission. The evaluation of whether the inclusion of non-Veterans in a proposed VA research activity is consistent with meeting the VA mission cannot be delegated to an Institutional Review Board (IRB) because the evaluation is not a human subjects protections issue; it is an institutional evaluation. In addition, VA conducts many exempt human subjects research activities that could involve non-Veterans. Not all exempt human subjects research activities require IRB approval. Common examples of exempt human subjects research activities involving non- Veterans are survey research involving caregivers and employees.

For VA studies involving subjects receiving treatment as inpatients or outpatients, VA has strict regulations in 38 CFR §17.45 and 38 CFR §17.92 stating that non-Veterans may only be included in VA research involving VA outpatient or VA inpatient treatment when there are insufficient Veteran patients suitable for the study. The R&D Committee should evaluate who will be responsible for paying for any medical care or treatment for non-Veterans included in research activities involving VA hospital inpatient or outpatient treatment because VA’s medical dollars appropriated for the care of Veterans cannot be used to provide care for non-Veterans.

Date Published: 2019-06-05

Is the VA Central IRB a subcommittee of the R&D Committee?

The VA Central IRB is not a subcommittee of the R&D Committee. It is an external committee established by a Memorandum of Understanding (MOU) between it and a VA Facility for VA Central IRB services. As stated in the Note in VHA Directive 1200.0, Paragraph 8.a., “External committees established by MOUs or other agreements in lieu of required subcommittee(s) are not considered subcommittees and are governed by the agreement (e.g. the VA Central IRB).” However, it is an internal VA IRB).

Date Published: 2019-06-05

Which two modules in the Collaborative Institutional Training Initiative (CITI) are required by ORD for the R&D Committee Chair and voting members to complete to meet the ORD training requirement in VHA Directive 1200.05 for training on ethical protections of human research protections?

VHA Directive 1200.01, Paragraph 14, states “Every 3 years the Chair and voting members of the R&D Committee are required to complete two modules from ORD and Collaborative Institutional Training Initiative (CITI) on ethical principles of human research protection. See https://www.research.va.gov/pride/training/options.cfm for approved courses and VHA Handbook 1200.05(2) for additional information.” There are two stages (basic and refresher) in CITI for VA’s Human Subjects Protections course. The required modules in the Human Subjects Protection course are:

For the basic stage:
History and Ethics of Human Subjects Research (ID: 498) Informed Consent (ID: 3)


For the refresher stages:
History and Ethical Principles (ID: 511)
History and Ethical Principles – Research vs. Practice (ID 993)


ORD has set up the above modules as a separate course for R&D Committee members at each of the VA Facilities. Learners can get to it via the “add a course” link in their own accounts. Those who have already taken the VA Human Subjects Protection training in CITI, which includes the training required for R&D Committee members, will not have to take additional training; CITI will automatically grant those individuals credit for having already completed the training for R&D Committee members, when they enroll in the new course. Please contact Dr. Alice Huang at alice.huang@va.gov with any questions about this training.

Date Published: 2019-06-05

Is the R&D Committee required to review and approve all subcommittee standard operating policies and procedures (SOPs)?

No. The R&D Committee is not required to review and approve all subcommittee SOPs. For example, the R&D Committee is not required to review and approve the content of subcommittee SOPs that the Institutional Animal Care and Use Committee (IACUC) approves for its Veterinary Medical Unit (VMU) management. VHA Directive 1200.01, Paragraph 9.b.(1) states the following with the section related to R&D Committee review and approval of subcommittee SOPs underlined:

The R&D Committee may approve a protocol contingent on the protocol being approved by one or more subcommittees. The R&D Committee must ensure the adequacy of each subcommittee’s review procedures, including reviewing and approving all subcommittee SOPs. Final approval may only be given after the R&D Committee receives documentation from all applicable subcommittees of their review and non-contingent approval. Final approval can be provided by a designated reviewer if there were no major changes made by the subcommittee(s). The designated reviewer must have sufficient documentation from the subcommittee(s) to make a determination about any changes requested. This final approval must be reported to the full R&D Committee at its next convened meeting and noted in the minutes.

ORD’s requirement of the policy statement in VHA Directive 1200.01, Paragraph 9.b.(1) related to review of subcommittee SOPs is that the R&D Committee must have a way to ensure that each of its subcommittees has effective standard operating procedures (SOPs) for protocol review. ORD does not prescribe the method used by each of the VA Facility’s applicable subcommittees to establish these SOPs. The subcommittee’s method for reviewing and approving its SOPs can be done by the subcommittee members or by other methods. For example, in many Institutional Review Boards (IRB) operated by VA Facilities, the VA IRB Administrator reviews and approves the IRB SOPs. To meet the ORD policy requirement, the R&D Committee should document how it evaluates the adequacy of each subcommittee’s review procedures.

Date Published: 2019-05-24

Is the ACOS/R&D (or Coordinator for Research in a smaller VA medical facility) required to continue conducting the following quality assurance reviews described in the rescinded VHA Handbook 1200.01 (January 15, 2009) even though they are not included in VHA Directive 1200.01 (January 24, 2019)?

a. Conducting an annual quality assurance review of publications assessing the acknowledgement of VA support and affiliation:
b. Providing an annual quality assurance review of research employees involved in human subject research to ensure the employees are working within their scopes of practice and their privileges allowed by the facility’s by-laws and granted to them by the facility; and
c. Providing an annual quality assurance review of Cooperative Research and Development Agreements (CRADAs) and other agreements in support of the research program or specific research projects and an assessment of the impact of these agreements on the research program, when applicable.

No. The ACOS/R&D (or Coordinator for Research in a smaller VA medical facility) is not required by ORD policy in VHA Directive 1200.01 to be responsible for the referenced quality assurance activities described in VHA Handbook 1200.01. The R&D Committee is required at least annually to conduct quality assurance and quality improvement activities as part of its review of all research related committees and subcommittees as described in VHA Directive 1200.01, paragraph 6.

Date Published: 2019-05-24

Is the VA Central IRB an internal IRB or an external IRB?

The VA Central IRB is an internal IRB. As stated in the Note in VHA Directive 1200.01, Paragraph 5.h. (7): “For purposes of this directive, use of the VACO IRB or another VA facility’s internal IRB is not considered to be an external IRB. See VHA Handbook 1200.05(2).” Internal IRBs include two types of IRBs: (a) a VA facility’s IRB supported, and staffed within the VA Facility, including registration of the IRB; and (b) the VA Central IRB.

Date Published: 2019-05-24

When is R&D Committee approval required for single patient expanded access protocols for investigational drugs or biologics or investigational medical devices?

The R&D Committee approval is required for single patient expanded access protocols for investigational drugs or investigational medical devices when IRB approval is required by FDA regulations for an expanded access protocol prior to the investigational medical product (drug, biologic, or medical device) being administered to the patient. The R&D Committee approval can be granted using a designated review procedure as permitted in VHA Directive 1200.01, Paragraph 9.e. (5) or the convened R&D Committee review procedure.

Date Published: 2019-05-24

Is the R&D Committee required to conduct continuing review for human subjects research activities approved by expedited review or transitioned to the 2018 Requirements of the Federal Policy for the Protection of Human Subjects (Common Rule) when the IRB does not conduct continuing review of the research activity?

No. The R&D Committee is not required to conduct continuing review of the non-exempt human subjects research activities because the research activities remain under the continuing oversight of the IRB.

Date Published: 2019-05-24

When can the R&D Committee approve the inclusion of non-Veterans through a designated review process?

VHA Directive 1200.01, Paragraph 13.a. describes the specific responsibilities of the VA Investigator and the R&D Committee when non-Veterans are proposed to be included in VA research. “. . . The investigator must justify including non-Veterans, and the R&D Committee must review the justification and provide specific approval for recruitment of non-Veterans.” If the VA research activity can be approved by a R&D Committee through a designated review process, such as exempt human subject research protocols and protocols approved by expedited review by the IRB, the review and approval for inclusion of non-Veterans in a VA research protocol can be done by designated review.

Date Published: 2019-05-24

Is the R&D Committee required to “approve” subcommittee minutes as part of the requirement for it to review subcommittees as described in VHA Directive 1200.01, Paragraph 6.f.?

“The R&D Committee reviews all research related committees and subcommittees at least annually in part by: reviewing the minutes of each subcommittee that reviews VA research protocols; by close communication with the subcommittees; and through Quality Assurance and Quality Improvement activities . . .”

No. The R&D Committee is not required to approve subcommittee minutes, but it must document in its minutes its review of the subcommittee minutes within 60 days of the subcommittee’s finalization of the minutes (VHA Directive 1200.01, Paragraph 8.a.(3)).

An example of documentation of the R&D Committee’s review of minutes when no issues required action is as follows: “The IRB’s minutes were reviewed by the R&D Committee; there were no issues requiring discussion or action.” An example of documentation of the R&D Committee’s review of minutes when issues required action is as follows: “The IRB’s minutes were reviewed by the R&D Committee; the IRB reviewed 101 protocol deviations for Dr. “121” in its last meeting, but there is no indication that any actions were taken by the IRB. Additional information will be requested from the IRB regarding its review of the protocol deviations for Dr. “121” and any required reporting.”

The R&D Committee reviews the subcommittee minutes as a method to evaluate whether the subcommittee is functioning effectively and efficiently. This is one aspect of the R&D Committee’s oversight of the VA Facility’sR&D program. The R&D Committee’s review of subcommittee minutes informs it of issues addressed or actions taken by the subcommittees that may require additional institutional action by the R&D Committee. The subcommittee minutes also provide the R&D Committee with documentation of the operations of the subcommittees. Reviewing these minutes is therefore a quality assurance activity permitting the R&D Committee to evaluate whether the subcommittee is serving the function for which it is constituted.

Date Published: 2019-02-08

What does the regulatory text state in the revised Common Rule regarding transitioning studies initially approved by an IRB under the pre-2018 Requirements?

§.101(l) of the revised Common Rule addresses compliance dates and transition provisions. The exact wording of the regulatory text in this section is as follows:

(l) Compliance dates and transition provisions:

(1) Pre-2018 Requirements. For purposes of this section, the pre-2018 Requirements means this subpart as published in the 2016 edition of the Code of Federal Regulations.
(2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this subpart. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for §46.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.
(3) Research subject to pre-2018 requirements. The pre-2018 Requirements shall apply to the following research, unless the research is transitioning to comply with the 2018 Requirements in accordance with paragraph (l)(4) of this section:

(i) Research initially approved by an IRB under the pre-2018 Requirements before January 21, 2019;
(ii) Research for which IRB review was waived pursuant to §46.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under §46.101(b) of the pre-2018 Requirements before January 21, 2019.

(4) Transitioning research. If, on or after July 19, 2018, an institution planning or engaged in research otherwise covered by paragraph (l)(3) of this section determines that such research instead will transition to comply with the 2018 Requirements, the institution or an IRB must document and date such determination.

(i) If the determination to transition is documented between July 19, 2018, and January 20, 2019, the research shall:

(A) Beginning on the date of such documentation through January 20, 2019, comply with the pre-2018 Requirements, except that the research shall comply with the following:

(1) Section 46.102(l) of the 2018 Requirements (definition of research) (instead of §46.102(d) of the pre-2018 Requirements);
(2) Section 46.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of §46.103(f) of the pre-2018 Requirements); and
(3) Section 46.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of §46.103(b), as related to the requirement for continuing review, and in addition to §46.109, of the pre-2018 Requirements); and

(B) Beginning on January 21, 2019, comply with the 2018 Requirements.

(ii) If the determination to transition is documented on or after January 21, 2019, the research shall, beginning on the date of such documentation, comply with the 2018 Requirements.

(5) Research subject to 2018 Requirements. The 2018 Requirements shall apply to the following research:

(i) Research initially approved by an IRB on or after January 21, 2019;
(ii) Research for which IRB review is waived pursuant to paragraph (i) of this section on or after January 21, 2019; and
(iii) Research for which a determination is made that the research is exempt on or after January 21, 2019.

Date Published: 2019-02-08

Is it mandatory for any studies to transition to the revised Common Rule?

Yes. Studies that utilized one of the burden-reducing provisions during the delay period (July 19, 2018 – January 20, 2019) must fully comply with the revised Common Rule on January 21, 2019. For VA Research this is limited to those studies that utilized the burden-reducing provision that eliminated the IRB review of the grant application or contract proposal during initial review §.101(l)(4)(i)(A)(2). VA did not allow the burden reducing provision of eliminating continuing review to be implemented.

These studies may not continue to comply with the pre-2018 Requirements after January 20, 2019. January 21, 2019 would be considered the documented date of transition. These studies may require additional IRB review and approval if there are changes required to comply with the revised Common Rule. If a study is found to have used the burden reducing provision and did not fully transition as of January 21, 2019, the institution must report the noncompliance to ORO (and any other applicable offices, e.g., the study sponsor) and take immediate corrective actions to transition the study.

ORD recommends that Investigators and IRBs that used the burden-reducing provisions ensure that all studies now comply with all requirements of the revised Common Rule.

Date Published: 2019-02-08

Who determines whether a study can be transitioned from the pre-2018 Requirements to the revised Common Rule?

ORD policy in VHA Directive 1200.05 requires that the VA Medical Center (VAMC) Director ensure that a procedure is in place for determining when a human subjects study initially approved by the IRB before January 21, 2019 can transition to the revised Common Rule. ORD created this policy so that a systematic procedure is implemented by the VA facility’s HRPP. A VA facility HRPP’s policy can be coordinated with its IRB(s) of Record.

There is no ORD policy requirement to transition any human subjects study approved by an IRB prior to January 21, 2019, unless a burden-reducing provision was used between July 19, 2018 and January 20, 2019. However, an Investigator, IRB or HRPP may find it advantageous to transition certain studies to the revised Common Rule. Investigators following procedures outlined by their IRB or Institution may request to transition studies compliant with the pre-2018 Requirements to the revised Common Rule. Only the IRB of Record for a specific study can approve this transition. An Investigator alone is not permitted to decide that his or her study can be transitioned to the revised Common Rule requirements or begin using the 2018 Requirements without IRB approval. IRB records should be clear whether a human subjects study approved prior to January 21, 2019 is subject to the pre-2018 Requirements. An IRB must document whether a study approved prior to January 21, 2019 has transitioned to comply with the revised Common Rule requirements.

Studies initially approved by an IRB on/after January 21, 2019 or studies that have already transitioned to the revised Common Rule MAY NOT request to comply with the pre-2018 Requirements.

NOTE: Any study that used the burden-reducing provision eliminating IRB review of the grant application or contract proposal during the initial IRB review must already have transitioned to the revised Common Rule requirements on January 21, 2019 (see Question 2).

Date Published: 2019-02-08

What documentation is required if a study initially approved by an IRB prior to January 21, 2019 is transitioned to comply with the revised Common Rule requirements?

The IRB of Record must provide written study-specific documentation to the Investigator with ample time provided for the Investigator to comply with the revised Common Rule. The IRB has authority over studies for which it has regulatory and ethical oversight. If the IRB decides to allow a study initially approved by an IRB before January 21, 2019 to transition to the revised Common Rule, it must provide written documentation to the Investigator with the date of transition. Investigators should be provided ample time to fulfill all requirements of the revised Common Rule before the study should be transitioned, particularly if there are regulatory requirements that must be met, such as the inclusion of new consent elements.

The IRB must notify all PIs of its desire to transition the study. Institutions may transition studies on a per-protocol basis or with respect to a broader category of research conducted at an institution. An IRB should not send group notifications to Investigators informing them that their studies have transitioned to the revised Common Rule without notifying them of the individual studies that will transition. For example, an IRB should not send notification to Investigators that all studies approved by the IRB prior to January 21, 2019 in data analysis phase only will automatically be transitioned to comply with the revised Common Rule requirements without specifying which studies are affected and the date of transition. Study-specific letters should be sent by the IRB to the Investigator informing the Investigator which studies and the date(s) of transition to the 2018 Requirements.

Date Published: 2019-02-08

What are the major applicable regulatory provisions an IRB should consider when it transitions a study from the pre-2018 Requirements to the revised Common Rule?

The revised Common Rule has made substantial changes to the regulatory requirements, particularly regarding informed consent and continuing review. A study initially approved by the IRB prior to January 21, 2019 (without the utilization of the burden-reducing provisions) cannot automatically transition to the revised Common Rule without an IRB written determination.

A study cannot be partially transitioned. This means that an IRB cannot selectively choose preferred revised Common Rule requirements or provisions to apply while continuing to apply provisions of the pre-2018 Requirements. However, IRBs may implement provisions of the 2018 Requirements that do not conflict with the pre-2018 Requirements at any time, such as additional elements or structure of informed consent. For example, a study approved by the IRB by expedited review prior to January 21, 2019 that is active to subject recruitment cannot choose to apply the provision at §.109(f)(1) eliminating the requirement for continuing review but not apply the informed consent requirements in §.116 at the revised Common Rule. Transition determinations should be made depending upon what study activities will be impacted by transitioning to the revised Common Rule. A study closed to enrollment will be impacted less than a study that initiated enrollment prior to January 21, 2019 and is continuing to enroll subjects.

The following is a list of the major applicable regulatory requirements an IRB should consider when a study initially approved by the IRB prior to January 21, 2019 is proposed to be transitioned to comply with the revised Common Rule requirements. (This is not intended to be an all-inclusive list for purposes of this guidance document):

(a) Compliance with FDA regulations 21 CFR Parts 50 and 56. Several FDA human subject protections provisions in 21 CFR Parts 50 and 56 are not congruent with the revised Common Rule’s requirements, particularly regarding exempt categories and continuing review requirements. Consideration should be given to studies that if transitioned to comply with the revised Common Rule requirements may result in noncompliance with the applicable FDA regulations. IRBs and PIs must remember that for studies subject to the FDA regulations, if transitioned the studies must continue to comply with both the revised Common Rule and the FDA regulations. For provisions that differ between both sets of regulations, investigators and IRBs should continue to follow the more stringent requirements. For instance, continuing review must be continued for a study subject to the FDA regulations, even if reviewed via expedited procedures.

(b) §.104 and §.111: Categories of exempt research and limited IRB review. If the study did not meet any of the exemption categories based on the pre-2018 Requirements, the IRB can evaluate whether the study activities now fall into an exemption category under the revised Common Rule. Exempt determinations may be made by the IRB Chair, an experienced IRB member, or qualified administrative staff with expertise in applying human research exempt regulations. Specifically, the individual making the determination should carefully consider prior non-exempt activities which meet exempt categories under the revised Common Rule. As non-exempt activities, many of these studies would have required informed consent; exempt studies do not. The IRB should consider whether a study that initially obtains study-specific consent should transition to an exempt category under the revised Common Rule, particularly those with primary data collection. Additionally, exemption categories at §.104(d)(2)(iii), §.104(d)(3)(i)(C), §.104(d)(7) and §.104(d)(8) require limited IRB review.

Question #10 in this guidance document addressing transitioning studies previously approved by an IRB to exempt human subjects research under the revised Common Rule.

(c) §.109(f)(1): IRB Review of Research. A study transitioned to the revised Common Rule requirements must follow the continuing review requirements described in this section. Thus, studies eligible for expedited review as well as studies at the final stages of data analysis or clinical follow up will no longer require continuing review by the IRB, unless justification for continuing to conduct continuing review is provided by the IRB.

(d) §.114: Cooperative Research. Compliance with the cooperative research provisions in the revised Common Rule is not required until January 20, 2020.

(e) §.116: General Requirements for Informed Consent. For studies involving informed consent that are open to enrollment, the IRB should consider whether the informed consent is compliant with the revised Common Rule and the level of impact transitioning the study may cause. If a study subject to the pre-2018 Requirements is transitioned to the revised Common Rule and subject recruitment is ongoing, subjects recruited after the date of transition must be consented with an informed consent compliant with the revised Common Rule. For subjects previously consented with an informed consent compliant with the pre-2018 Requirements, it is up to the IRB to determine if these subjects must be re-consented or informed of changes to the consent document or process. Additional information regarding IRB considerations for studies initially approved by an IRB without a waiver of informed consent are described in Question #9 in this guidance document.

(f) §.116(h): General Requirements for Informed Consent: Posting of clinical trial consent form. If a clinical trial subject to the pre-2018 Requirements is transitioned to the revised Common Rule or it is transitioned within 60 days of the last study visit by a subject at all subjected sites, a copy of the clinical trial consent form used to enroll subjects must be posted. Studies transitioned to the revised Common Rule will not be considered out of compliance if the posted consent form remains compliant with the pre-2018 Requirements.

If a clinical trial is transitioned to the revised Common Rule requirements, subject enrollment is complete, and the date of transition is 60 days or greater after the last study visit, ORD does not require a copy of the clinical trial informed consent form approved by the IRB to be posted.

If a study approved by the IRB prior to January 21, 2019 is transitioned to comply with the revised Common Rule requirements, the study will be evaluated for compliance based upon which Common Rule requirements were applicable at the time the activities were conducted. Thus, for ongoing studies subject to continuing review that are transitioned, activities conducted prior to transitioning are subject to the pre-2018 Requirements while activities conducted on or after the date of transition are subject to the revised Common Rule. The decision whether to transition a study to the revised Common Rule for previously approved studies should be carefully evaluated by the IRB with consideration of both the advantages and disadvantages of transitioning previously approved studies, especially if the transitioned study under evaluation is projected to close within a short period of time.

Date Published: 2019-02-08

What happens to a VA study that was initially approved by an IRB prior to January 21, 2019 that does not transition to the revised Common Rule?

If a VA study approved by an IRB before January 21, 2019 (without the use of the burden-reducing provisions) does not transition to the revised Common Rule, the study must continue to comply with the pre-2018 Requirements and any other applicable regulations or policies.

Date Published: 2019-02-08

For multisite, non-exempt studies involving multiple IRBs with initial IRB approval under the pre-2018 Requirements, can some sites transition to the revised Common Rule without all sites transitioning?

ORD’s recommendation is that multisite non-exempt studies subject to the pre-2018 Common Rule, should follow the same Common Rule regulations at all sites. The Principal Investigator, Investigators from the multiple sites, and the IRBs of Record at the engaged institutions should communicate about the possibility of transitioning studies, considering all advantages and disadvantages of transitioning a multisite study to the revised Common Rule versus maintaining compliance with the pre-2018 Requirements. Investigators should notify their IRB of Record immediately if they are alerted that a site of a multisite study has transitioned without coordination.

The application of human subjects protections in the conduct of research should be consistent. If a multi-site study is being conducted compliant to different sets of regulations for different sites, inconsistency in the conduct and regulatory oversight of the activity by the applicable Investigators and reviewing IRBs may be introduced. For example, an expedited study that remains compliant with the pre-2018 Requirements at Institution A would require continuing IRB review whereas if another site transitions the study to the revised Common Rule, it would no longer require continuing review at Institution B. Thus, ORD recommends that the investigators and IRBs decide on one set of Requirements for all engaged sites.

For multisite, non-exempt studies with initial IRB approval prior to January 21, 2019, the greatest benefit to transition may be offered to those that have progressed to the point that involve only 1) data analysis [§109(f)(iii)(A)] or 2) accessing clinical data from procedures that subjects would undergo as part of clinical care as described in §109(f)(iii)(B) and thus would no longer require continuing review after transitioning.

Multisite, non-exempt studies that utilized a burden-reducing provision during the delay period must have transitioned to the revised Common Rule on January 21, 2019. This may be specific to the site(s) that used a burden-reducing provision. Investigators learning of a site transition of a multisite study should notify their IRB of Record immediately.

Date Published: 2019-02-08

For multi-site, non-exempt studies where some sites have IRB approval prior to January 21, 2019 and other sites have IRB approval on or after January 21, 2019, which regulations apply to each site?

The Common Rule requirements that a study is subject to depends on the date of IRB approval. However, for multi-site studies there are several factors that may determine which set of requirements the study and at which site it must comply. Multi-site studies that have IRB approval prior to January 21, 2019 at one or more sites are subject to the pre-2018 Requirements at those sites. If additional sites are added to the study on or after January 21, 2019, the Requirements of the study at those additional sites depends on which IRB provides review and approval. If the additional sites rely on the IRB that previously approved the study prior to January 21, 2019, the study must follow the requirements of the IRB for which it is relying.

For example, a multi-site study received IRB approval at Institution A on December 20, 2018. Institution A decides to keep the study under the pre-2018 Requirements. Institution B is added as a study site on January 30, 2019. If Institution B is relying on Institution A’s IRB, the study is subject to the pre-2018 Requirements at both Institutions A and B. Additionally, if Institution A decides to transition the study to the 2018 Common Rule, then the study at both Institutions A and B must comply with the 2018 Requirements.

Alternatively, if additional sites are added to a study after January 21, 2019 and those sites will not rely on a previously approving IRB, instead, relying on their own (or another) IRB, the study at these added sites must follow the revised Common Rule (2018 Requirements). To continue with the above example, Institution C is added as a study site on February 10, 2019 and will use its own IRB to review and approve the study. At Institution C, the study must comply with the revised Common Rule, while at Institutions A and B the study may either continue to comply with the pre-2018 Requirements or transition to comply with the revised Common Rule. If all three sites would like to comply with the same regulations, Institutions A and B must transition the study to the revised Common Rule.

ORD recommends that all sites follow the same Regulations for a given study regardless of number of sites.

Date Published: 2019-02-08

Does the VA require subjects from whom informed consent was obtained under the pre-2018 Requirements be reconsented if the study is transitioned to the revised Common Rule?

The IRB must decide if previously consented subjects must be reconsented or notified of changes under the requirements of the revised Common Rule. Subjects agree to participate in a study based on the information provided and approved by the IRB. The IRB should consider whether changes to the consent form required by the revised Common Rule impact the actual study requirements and participation. Reconsenting subjects who have already agreed through their prior consent to participate in the study may create burden with minimal impact on protecting human subjects, particularly if there are no changes to study participation.

For studies that are closed to enrollment, the IRB must consider whether the additional informed consent requirements at §.116 are significant enough to require revising the informed consent document, particularly if subject participation continues.

For studies that are open to subject enrollment and require informed consent, any subject consented into the study on/after the date of transition must be consented using the informed consent requirements described in §.116 of the revised Common Rule.

For studies that are open to subject enrollment and have subjects who previously consented and are continuing participation, newly enrolled subjects must be consented using the consent form compliant with the revised Common Rule. The decision to re-consent previously enrolled subjects or inform them of the changes caused by compliance with the revised Common Rule is decided by the IRB.

ORD’s position regarding reconsenting of subjects enrolled prior to the transition date is that subjects usually should not be reconsented for the sole purpose of transitioning the study to the revised Common Rule. However, the IRB makes the final determination whether to require reconsenting or notification of previously enrolled subjects. If after transitioning the study the IRB requires reconsenting of some or all subjects in the study (e.g., a new risk of the research was discovered that required reconsenting as determined by the IRB), those subjects, regardless of whether they are entered into the study using the prior or current Common Rule requirements, must be reconsented using an IRB-approved informed consent compliant with the revised Common Rule requirements in §.116.

Date Published: 2019-02-08

May studies considered non-exempt prior to January 21, 2019 be transitioned as an exempt study under the revised Common Rule?

Yes, studies considered non-exempt under the pre-2018 Requirements may transition to an exemption under the revised Common Rule. The transition provisions in §.101 do not prohibit a study initially requiring IRB review and approval from transitioning to an exempt category. The revised Common Rule places many minimal risk human subjects research activities that require IRB approval under the pre-2018 Requirements into an exempt research category. However, ORD does not recommend transitioning studies requiring informed consent under the pre-2018 Requirements to an exemption category under the revised Common Rule if subject enrollment is on-going.

During enrollment, transitioning a study to exempt status can be complicated. For example, a VA researcher is conducting a study consisting of qualitative interviews of Veterans who have experienced traumatic brain injury. Identifiable data are recorded, transcribed and analyzed. Given its regulatory category, under the pre-2018 Requirements, this activity requires IRB review and approval using an expedited process. Most likely the PI is required to obtain informed consent from subjects. It is important to consider that exempt research does not require informed consent. Transitioning a study initially approved by an IRB prior to January 21, 2019 requiring informed consent that will no longer require informed consent for subjects raises ethical considerations for what information is given to newly-enrolled, potentially unconsented subjects participating in the transitioned study. ORD recommends that if such a study is transitioned to an exempt category that all newly enrolled subjects continue to undergo the informed consent process approved by the IRB prior to transition.

Lastly, studies approved by the IRB during the delay period (July 19, 2018 – January 20, 2019) that used a burden-reducing provision must have transitioned to the revised Common Rule as of January 21, 2019. If once transitioned, a study previously considered non-exempt is now considered exempt under the revised Common Rule, the IRB must follow standard operating procedures to transition the study as exempt, this may include a determination of exemption by an appropriate person and limited IRB review. Additionally, if a previously non-exempt study is transitioned as exempt it will no longer remain under the oversight of the IRB but rather would require continuing review by the R&D Committee according to VHA Directive 1200.01, unless under the oversight of another subcommittee.

For exemption categories at §.104(d)(2)(iii) and §.104(d)(3)(i)(C), there is a require of limited IRB review to determine whether there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. If a non-exempt human subjects study has already been approved by the IRB under the pre-2018 Requirements there should be no need to re-review or conduct a limited IRB review as the corresponding criteria at §.111(7) have already been met and been approved.

Date Published: 2019-02-08

For distinguishing the applicable regulations, what type of tracking is recommended for IRBs subject to both Common Rules?

Until all studies with initial IRB approval prior to January 21, 2019 have either closed or transitioned to the revised Common Rule, the regulatory community will have to consider two sets of requirements. IRBs, Investigators, and institutions should clearly indicate which set of requirements (pre-2018 Requirements or the revised Common Rule) each study is subject to. There are four major groups of studies that need to be tracked:

- Studies subject to the pre-2018 Requirements: research with initial IRB approval before January 21, 2019.

- Studies that transition to the revised Common Rule: research with initial IRB approval before January 21, 2019 that transition to comply with the revised Common Rule. This includes studies that used a burden-reducing provision during the delay period of July 19, 2018 and January 20, 2019. IRB records of transitioning studies must include the date of transition.

- Studies subject to the revised Common Rule: research with initial IRB approval on or after January 21, 2019.

- Studies that require continuing review and those that do not require continuing review.

Date Published: 2018-07-27

How does the delay in the general compliance date of the 2018 Requirements impact VA Research?

The delay of the general compliance date of the 2018 Requirements of the revised Common Rule does not negatively impact ongoing VA research involving human subjects. It provides additional time for VA human research protection programs and the IRBs serving as IRBs of Record to prepare for implementing the 2018 Requirements. Until January 21, 2019, human subjects research must comply with the pre-2018 Common Rule requirements. All non-exempt VA human subjects research must be reviewed by the IRB in accordance with the current Common Rule unless a study utilizes the burden-reducing provision eliminating IRB review of the grant application or contract proposal. Implementing the burden-reducing provision that deems certain activities not to be research does not impact VA research because those four (4) activities currently do not meet the definition of research involving human subjects under the pre-2018 Requirements.

Date Published: 2018-07-27

Will the Final Rule effective on July 19, 2018, delaying the general compliance date of the 2018 requirements also delay the compliance date of the Cooperative Research Provision?

The compliance date of the cooperative research provision (use of a single IRB for most multi-site research) described in the 2018 Requirements at §__.102 remains unchanged, i.e., January 20, 2020.

Date Published: 2018-07-27

What are the three burden-reducing provisions allowed to be implemented on July 19, 2018 by the Final Rule?

The Final Rule issued on June 19, 2018, delays the compliance date of the 2018 Requirements to January 21, 2019, while allowing the implementation of three burden-reducing provisions effective on July 19, 2018. The three burden-reducing provisions are as follows:

(1) the 2018 Requirements’ definition of ‘‘research’’ at §__.102(l), which deems certain activities not to be research,
(2) the elimination of the requirement that an IRB review the grant application related to the research at §__.103(d) of the 2018 Requirements, and
(3) the allowance for no annual continuing review of certain categories of research at §__.109(f)(1)(i) and (iii) of the 2018 Requirements.

Revised definition of “research” (§__.102(l))

The 2018 Requirements does not change the definition of research but specifies four areas of activities that are deemed not to be research for the purposes of the Common Rule. At §__.102(l), the 2018 Requirements clarify that the following activities are deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Elimination of the requirement that an IRB review the grant application (at §__.103(d))

At §__.103(d) of the 2018 Requirements, IRBs are no longer required to review the grant application or contract proposal when reviewing the study protocol and other related IRB materials.

Elimination of continuing review for certain categories of research (§__.109(f)(1)(i) and (iii))

The pre-2018 Requirements require IRB review and approval no less than annually for all non-exempt human subjects research subject to the Federal Policy for the Protection of Human Subjects. In VA, all non-exempt human subjects research is subject to the Federal Policy for the Protection of Human Subjects. The 2018 Requirements identify certain categories of research that will no longer require continuing IRB review after the initial IRB approval.

Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

· research eligible for expedited review in accordance with the expedited review categories; and
· research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:

(A) data analysis, including analysis of identifiable private information or identifiable biospecimens, or
(B) accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Date Published: 2018-07-27

Can all three burden-reducing provisions apply to VA research activities as of July 19, 2018?

No, VHA cannot implement all three-burden reducing provisions as of July 19, 2018. VA non-exempt human subjects research cannot currently utilize the burden-reducing provision for elimination of continuing review for certain categories of research as part of the three-burden reducing provisions. ORD policy in VHA Handbook 1200.05, § 8.e requires that the IRB conduct continuing review of all VA non-exempt human subjects research at intervals appropriate to the degree of risk, but no less than once per year. ORD requires that continuing review by the IRB of Record must continue for all VA non-exempt human subjects research must continue until January 21, 2019, including studies relying on an external IRB.

VHA can implement the updated definition of research that deems certain activities not to be research as this does not differ from VA’s current policy. VHA can also implement the discontinuation of the IRB review of the grant application or contract proposal as discussed below.

Date Published: 2018-07-27

Is an IRB or Instiution required to use the burden-reducing provisions as of July 19, 2018, for applicable activities?

No. An IRB or individual institution may elect to use the revised definition to clarify that certain activities are not considered research under the Common Rule or choose to discontinue IRB review of the grant application or contract proposal. If an institution or IRB decides to discontinue the IRB review of the grant application or contract proposal, ORD recommends that the decision be made on a study-by-study basis rather than a decision applicable to all studies. ORD’s recommendation is based upon the consideration that studies that use the provision will be automatically to transition to all of the 2018 Requirements on January 21, 2019. The decision to use the provision and thus transition a study should be made with the consideration of whether use of the provision ultimately reduces the burden.

If a study is reviewed by the IRB without review of the grant or contract as of July 19, 2018, there should be clear documentation of that decision. The IRB should maintain appropriate records to track those studies that are reviewed using this burden-reducing provision prior to January 21, 2019, as these studies will be required to transition to all of the 2018 Requirements on January 21, 2019.

Studies approved by the IRB prior to January 21, 2019 and that do not use the provision must continue to comply with the pre-2018 Requirements unless specifically transitioned to the 2018 Requirements after January 21, 2019. ORD also wishes to reinforce that there is no ORD policy requirement to transition any non-exempt VA human subjects study approved prior to January 21, 2019 to the 2018 Requirements, even after January 21, 2019.

Date Published: 2018-07-27

Who documents whether or not a VA study has taken advantage of one of the burden-reducing provisions in the Final Rule effective on July 19, 2018?

ORD recommends that documentation of an institution’s decision to implement and apply the permitted burden-reducing provisions should be made by the IRB and the institutional official who has the authority to make the determinations on behalf of the institution. For research subject to IRB approval, the IRB should document as described in standard operating policies and procedures when it utilizes the burden-reducing provision so that it is clear that the study must transition and comply with all of the 2018 Requirements on January 21, 2019.

Date Published: 2018-07-27

Is there a possibility that VHA Handbook 1200.05's policies regarding continuing review may change prior to January 21, 2019, to allow elimination of continuing review for certain categories of research (§ 38.109(f)(1)(I) AND (III))?

No. There is no plan to amend VHA Handbook 1200.05 for the sole purpose of allowing elimination of continuing review for certain categories of research ((§ 38.109(f)(1)(I) and (III)). VHA Handbook 1200.05 is currently undergoing a major revision to incorporate the 2018 Requirements.

Date Published: 2018-07-27

How should the Associate Chief of Staff for Research and Development (ACOS/R&D) or IRB document that a study has utlized one of the burden-reducing provisions?

The Final Rule does not dictate a specific manner. ORD recommends that standard language be added to the IRB letter for the approval of the non-exempt study and/or the ACOS letter to the investigator notifying the investigator that the research may be initiated to identify and communicate which studies must transition on January 21, 2019. For example:

The IRB review of this study was conducted without review of the grant application or contract proposal, therefore, as of January 21, 2019, this study must comply with all the 2018 requirements of the federal policy for the protection of human subjects.

Date Published: 2018-07-27

How does the revised defintiion of research in the Final Rule, effective on July 19, 2018, impact the VA?

The specific exclusion of the activities deemed not to be research does not impact VA research activities. These activities were already not considered to be research by VA.

Date Published: 2018-07-27

Do studies that take advantage of elimination of IRB review of grant or contract proposals prior to January 21, 2019, have to comply with the 2018 Requirements on January 21, 2019?

Yes. Individual studies that are reviewed by the IRB prior to January 21, 2019, without reviewing the grant application or contract proposal (burden-reducing provision at §__.103(d)) must be in compliance with all other requirements of the current pre-2018 Requirements but must automatically transition to all of the 2018 Requirements on January 21, 2019. This impacts key issues for the approved study, such as the informed consent document, if applicable. For example, Study A is to be reviewed by the IRB between July 19, 2018, and January 20, 2019, and the IRB decides not to review the grant application with the protocol. At the time of IRB review, Study A must comply with the pre-2018 Requirements for the general requirements for informed consent found at §46.116. The PI writes the consent form in accordance with current practices and standards. On January 21, 2019, Study A will automatically transition to the 2018 Requirements and thus must comply with all of the 2018 Requirements, including the general requirements for informed consent at §46.116 in the revised Common Rule. There may be significant differences in the requirements for informed consent for Study A. If the PI neglects to update the consent form, Study A may be out of compliance with the 2018 Common Rule.

IRBs should have a plan to track all studies that implement the allowable burden-reducing provisions and a plan to transition those studies to the 2018 Requirements on January 21, 2019. Those studies may need to be re-reviewed to determine if they are in compliance with the 2018 Requirements.

Investigators should be made aware of the institution’s decision to discontinue the IRB review of the grant application or contract proposal and whether it is done for all non-exempt human subjects research or a decision made per study. For institutions that decide to discontinue the IRB review of the grant application, ORD recommends that the investigator make the applications available upon request.

Date Published: 2018-07-27

If a determination is made and documented for a Federally-supported VA study to take advantage of the use of the burden-reducing provision to eliminate IRB review of the grant application, is a grant review required by the VA R&D Committee?

No. There is no VA policy that requires the R&D Committee to review the grant application or contract proposal. However, if this is the standard practice at a local VA Medical Center, then it can continue.

Date Published: 2018-07-27

What are the general Institutional or IRB Responsibilities if the decision is made to allow use of the burden-reduing provisions permitted by ORD?

These are ORD’s recommendations of general responsibilities of VA Facilities and IRBs if a decision is made to utilize the burden-reducing provisions after July 19, 2018. ORD wishes to reinforce that it is optional to utilize the burden-reducing provisions. There is no requirement by ORD or the regulations to utilize the burden-reducing provisions.

Document – The institutional official, either the Medical Center Director or the ACOS/R&D, should document the institution’s decision to implement and apply the burden-reducing provisions. IRBs should also document which individual studies will make use of the burden-reducing provision and therefore must transition to all of the 2018 Requirements on January 21, 2019.

Update SOPs – IRBs will need to update or revise their standard operating procedures to allow for the elimination of the IRB review of the grant application or contract proposal.

Plan – IRBs should determine a plan for transitioning ongoing studies reviewed using the burden-reducing provision from the pre-2018 Requirements to the 2018 Requirements. This plan should become part of a new or updated standard operating procedure by January 21, 2019.

Communicate – IRBs and/or the VA institutional officials (Medical Center Director, ACOS/R&D) should ensure that all applicable individuals and groups within the VA Facility’s Human Research Protection Program are aware of whether the burden-reducing provision eliminating the IRB review of the grant application or contract proposal will be utilized, either for all protocols or on a protocol-specific basis.

Date Published: 2018-03-12

Can My HealtheVet Secure Messaging be used by VA researchers?

Yes, My HealtheVet Secure Messaging can be used by VA researchers to communicate securely with VA subjects who have consented to participate in a VA approved research activity as approved by the VA Facility’s Institutional Review Board (IRB) of Record as described in VHA Handbook 1200.05: Requirements for the Protections of Human Subjects in Research. VA researchers can use Secure Messaging to send VA sensitive information to VA research subjects. However, Secure Messaging cannot be used to recruit VA subjects or as part of any recruitment activities in research.

Date Published: 2018-03-12

Why can’t My HealtheVet Secure Messaging be used for research recruitment activities?

At the present time, there is no option available for individuals with a My HealtheVet account to “opt-in” or “opt-out” of receiving research recruitment messages. Individuals with an account should have the ability to decide whether or not they wish to receive research recruitment messages or flyers through Secure Messaging. Therefore, until functionality is expanded to allow individuals with a My HealtheVet account to choose whether or not they wish to receive recruitment information or advertisements for research, use of Secure Messaging to recruit research subjects is not permitted.

Date Published: 2018-03-12

What is a VA researcher required to submit to an Institutional Review Board if they want to use My HealtheVet Secure Messaging to communicate with consented VA subjects?

As part of an IRB’s evaluation of non-exempt research, the IRB must apply the approval criteria in 38 CFR 16.111 as described in VHA Handbook 1200.05, Paragraph 10. These criteria include evaluation of communications provided to study participants in order to ensure that appropriate safeguards exist to protect the rights and welfare of research subjects and, when appropriate, that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (38 CFR 16.111(a)(7)).

A research activity may use multiple methods to communicate with research subjects, such as face-to-face communication, telephone calls, letters sent by U.S. mail, My HealtheVet Secure Messaging, email, or text messaging. The specific types of communication that will be utilized in a particular research study must be specified in the study protocol, IRB application, or supplement to the IRB application as part of the IRB application process. Please note that applicable information security and privacy requirements described in VA 6500: Information Security Handbook and VHA Directive 1605.01: Privacy and Release of Information must be adhered to in addition to IRB approval requirements for non-exempt human subjects research activities. The study team will need to specify in the study protocol, IRB application, or supplement to the IRB application if Veterans can choose Secure Messaging, traditional methods such as telephone calls or letters sent by U.S. Mail, or a combination of communication methods. If a VA researcher is planning to use standardized messages that will be sent to research participants through Secure Messaging, the content of these messages must be reviewed by the IRB of Record for the research activity.

In addition, My HealtheVet Secure Messaging allows VA staff to save all or part of a Secure Message or message thread that is deemed clinically relevant as a Text Integration Utilities (TIU) note in the Computerized Patient Record System (CPRS). These TIU notes are then accessible to all VA staff with appropriate access to the individual’s VHA Electronic Health Record. Therefore, as part of the informed consent process, prospective subjects must be informed that any research related notes saved in CPRS could be viewed by any VA staff with appropriate access to view the subject’s VHA Electronic Health Record.

Date Published: 2018-03-12

Is a VA researcher required to use a specific format for naming the My HealtheVet Secure Messaging Triage Group for a specific study?

A study-specific name must be used when My HealtheVet Secure Messaging is used for a research study. This study-specific name allows the individual with a My HealtheVet account to distinguish between Secure Messages that are related to his or her healthcare versus research related communication. The study-specific name is created using a combination of four items: two standardized phrases and two study-specific phrases. The required format is a combination of three letters indicating the study site, the word “Research”, the study name or a short phrase that would allow identification of the message with the study, and “STUDY_RES”. Note that the character limit for the Secure Messaging Triage Group is 50 characters. The My HealtheVet Coordinator at the local VA facility should be consulted when a VA researcher is ready to establish a study-specific name for the study’s Secure Messaging Triage Group. For example, if the Baltimore VA was a participating site in a multisite study called, “A comparison of Type II Diabetes and three modalities of activity to evaluate short-term and long-term effects on physical and psychological complications of Diabetes”, the study-specific name for the associated Secure Messaging Triage Group would be:

BAL-RESEARCH-DIABETES AND ACTIVITY-STUDY_RES

The above applies the following in creating a specific study-name for use of Secure Messaging: [3 Character Site]-RESEARCH-[Study Name]-STUDY_RES

Date Published: 2018-03-12

What do VA researchers need to do to use My HealtheVet Secure Messaging once the IRB of Record and R&D Committee have approved a VA study?

To participate in My HealtheVet Secure Messaging, VA researchers, including any research team member using Secure Messaging, must receive education and training on the use of Secure Messaging. Each Veterans Integrated Service Network (VISN) and VA Facility has a My HealtheVet Coordinator/Secure Messaging Administrator to help facilitate and implement Secure Messaging within their purview. Once the necessary training has been completed, the My HealtheVet Coordinator/Secure Messaging Administrator will activate the research team member’s account within the Secure Messaging Administrative Portal.

The My HealtheVet Coordinator at the local VA facility should be consulted to finalize the study-specific name that will be used for the Secure Messaging Triage Group. Once the study-specific name has been finalized and the research team members’ accounts are activated, the VA research study team should identify the triage process that will be used for incoming Secure Messages. Any/all members of the study team Secure Messaging Triage Group can set their individual preferences to be alerted when a message is received from a VA subject. Research subjects can then be manually associated with the study team Secure Messaging Triage Group once they are consented into the study so that an association is created between the research team and the subject. The My HealtheVet Coordinator at the local VA facility can assist with setting up a Secure Messaging Triage Group and adding individuals by manual association.

Date Published: 2018-03-12

If I already receive My HealtheVet Secure Messages from patients in the context of my clinical service at VA, what do I need to do to establish a separate Secure Messaging triage group for messages from study participants in the context of my research?

If you are a VA researcher who also provides primary or specialty care, you may already be using Secure Messaging. Although VA staff can belong to multiple Secure Messaging Triage Groups, it is important to note that all Secure Messaging users have one set of preferences for New Message Notification and Inbox View. For example, if the Secure Message User has his or her Secure Messaging Preferences set to be notified of a Secure Message only when it is specifically assigned to him or her, and to only see Secure Messages that have been specifically assigned to the them in the Secure Messaging Inbox; he or she would not see a new message that came in for the triage team unless someone else on the team opened it and reassigned it to the them. This “on assignment” preference works for most primary and specialty care teams because an RN, LPN or an MSA that is also on the team is typically the initial reviewer of messages for that team, handling what they can and reassigning what they cannot resolve. The VA research team can also designate a study team member to review and triage incoming secure messages and respond or assign them to other team members as needed. This may be an effective strategy for VA researchers who are also providers and therefore, may want to keep their Message Notification and Inbox View Preferences to “On Assignment” and “Only Messages Assigned to me” respectively.

Date Published: 2018-03-12

What do VA researchers need to do if a Veteran has been enrolled into a VA study but does not yet have a Premium My HealtheVet account?

There are three different types of My HealtheVet user accounts: Basic, Advanced, and Premium. In order to use My HealtheVet Secure Messaging, the Veteran must be registered for an account (Basic), correlated with the Master Veteran Index or MVI (Advanced), and complete a onetime authentication process (Premium). Authentication is a process by which VA verifies a Veterans’ identity before allowing access to all of the features of the My HealtheVet patient portal, including Secure Messaging. The Authentication process can be done in-person or online. Please refer the Veteran to the local VA Facility’s My HealtheVet Coordinator if the Veteran wishes to utilize My HealtheVet Secure Messaging but does not yet have a Premium My HealtheVet account. Please note that the Veteran will need to select “VA Patient” when they register for their My HealtheVet account or update their profile.

Please keep in mind that a Veteran’s participation in research and use of My HealtheVet Secure Messaging is voluntary. VA researchers are encouraged to develop alternative strategies of communicating sensitive information to VA research subjects if the use of My HealtheVet Secure Messaging is not desired by the Veteran. Alternatively, if a particular study requires access to Secure Messaging as an integral part of the study design, this should be noted in study eligibility criteria and also outlined in the study protocol.

Date Published: 2018-03-12

What instructions should VA researchers give to Veterans regarding communicating with the study team using My HealtheVet Secure Messaging?

VA researchers should consider how and when instructions will be given to VA research subjects when Secure Messaging is used for study related communication. Instructions may need to be given orally and/or in writing. Instructions should be specific enough that the VA research subject is able to identify when the study team is communicating with him or her through the use of the study-specific Secure Messaging Triage Group and how to contact the study team through My HealtheVet Secure Messaging.

Operationally, both Veterans and the research team may have training needs, including training on use of My HealtheVet Secure Messaging. These learning needs should be identified as part of standard operating procedures for the study before the study is submitted to the IRB of Record. Veterans and staff may need to be provided with training on the use of Secure Messaging by the Research Staff and/or the local VA Facility My HealtheVet Coordinator.

Date Published: 2018-03-12

If a Veteran sends a complaint about the research study through My HealtheVet Secure Messaging, does it require reporting to the IRB of Record or is there a special reporting system?

Complaints sent by a Veteran thru My HealtheVet Secure Messaging are evaluated in the same way as any complaint received from a VA subject in a VA research study. The Investigator or Research Team member must refer to local Human Research Protection Policy procedures to determine when the complaint is to be reported to the IRB of Record for the specific study.

Date Published: 2018-03-12

What happens if a VA research team member receives a Secure Message from a Veteran that is intended for the Veterans’ health care team?

Secure Messages can be reassigned to another Secure Messaging Triage Group or individual using the Internal Healthcare Team Communications Box. Instructions on how to reassign a Secure Message can be found on the My HealtheVet Product Website on the VA Intranet. If a VA research team member receives a Secure Message from a Veteran that was intended for the Veteran’s health care team, it must be properly reassigned to the appropriate Secure Messaging Triage Group or individual to ensure delivery to the intended recipient.

Date Published: 2018-03-12

How should communication with VA subjects via My HealtheVet Secure Messaging be documented? What if a VA research study has a Certificate of Confidentiality?

Secure Messages to and from VA subjects, as part of a VA approved study, are considered part of the investigator records that must be retained as required by VHA’s Record Control Schedule 10-1. VA researchers are strongly encouraged to routinely save a copy of all messages sent and received using My HealtheVet Secure Messaging since messages are only available for display for one year.

Some studies, however, have a Certificate of Confidentiality. A Certificate of Confidentiality (CoC) is issued for applicable Department of Veterans Affairs (VA) research by several Department of Health and Human Services (DHHS) agencies to protect research subjects by preventing investigators and institutions from being forced or compelled to release identifiable information on research subjects. It allows the investigator and others who have access to research records to refuse to disclose identifying information on research subjects in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. The CoC helps to minimize risks by adding an additional level of protection for maintaining the privacy and confidentiality of research subjects in a VA study. Current ORD policy in VHA Handbook 1200.05, Paragraph 21 states that for studies with a Certificate of Confidentiality that do not involve a medical intervention (e.g., observational studies, including interviews and questionnaire studies), no annotation may be made in the health record. Therefore, if the VA study does not involve a medical intervention, My HealtheVet Secure Messaging communications cannot be saved as a TIU note in the subject’s VHA health record. In this case, the VA research team should document the communication in the investigator’s research file.

For studies that do involve a medical intervention, My HealtheVet Secure Messaging allows VA staff to save all or part of a Secure Message or set of related messages (message thread) that is deemed clinically relevant as a TIU note in CPRS.

For studies that involve a medical intervention but that also have a CoC, ORD policy states that any details that would affect the subject’s clinical care are to be included in progress notes. The VA Principal Investigator (PI) is responsible for determining which My HealtheVet Secure Messaging communications will be documented in CPRS. If the Secure Messaging communication involves a subject safety issue as determined by the VA PI, it must be documented as a TIU note in CPRS and follow all other reporting requirements as dictated by facility, regional (state) and national regulations, including verbal and written communication to patients, facility operations, and local authorities. Subject safety is always the first priority and should never be compromised by withholding information needed by a VA research subject’s health care team.

Date Published: 2018-03-12

What are the business rules for the timeliness of response to a Veteran Secure Message?

It is very important that Secure Messages are responded to within a timely manner and marked as complete within the Secure Messaging application. Secure Messages must be marked as complete within three (3) federal business days or they will escalate within the Secure Messaging application. Secure Messages are completed by the user by changing the message status to Complete. Secure messaging response time will be stated clearly to all participants when the participant enrolls in the study.

Date Published: 2018-03-12

How can I learn more about My HealtheVet Secure Messaging?

The My HealtheVet Product website on the VA intranet provides a variety of resources to learn more about how to use My HealtheVet Secure Messaging.

You can also email MHVSecureMessagingFieldQuestions@va.gov with specific questions about accessing and using HealtheVet Secure Messaging.

Date Published: 2018-03-12

What is My HealtheVet?

My HealtheVet (www.myhealth.va.gov) is an online portal created by the Department of Veterans Affairs to help Veterans, active-duty service members, and their dependents work with healthcare providers to reach informed decisions and improve their overall health. My HealtheVet offers a suite of tools designed to assist Veterans in managing their health care. VA patients with a Premium My HealtheVet account can access their health records, refill VA prescriptions, receive email reminders about appointments, and communicate with members of their healthcare team and other VA staff using Secure Messaging.

Date Published: 2017-07-28

Why is a MTA important?

MTAs document a chain of custody for any VA biospecimens which are shared or transferred. VA is entrusted with ensuring that these VA biospecimens are used in a manner that respects the preferences and wishes of Veterans. the MTA serves as a documentation of a chain of custody for any VA specimens that are shared or transferred by documenting the authority required for use of those biospecimens as well as describing how the biospecimens may be used (e.g., the purpose of the use). The MTA also describes the stewardship of the shared or transferred biospecimens. Stewardship is a care-taking responsibility for the biorepository from the time the biospecimen is collected (when possible) through its use, distribution and destruction (when applicable). ORD recommends the use of a MTA when VA research biospecimens are shared or transferred to another non-VA entity or institution, such as a university.

Date Published: 2017-07-28

Can a MTA be used solely for VA research biospecimens obtained from consented VA subjects?

An MTA can involve sharing or transferring of identifiable, coded, or de-identified VA biospecimens which were initially collected or obtained with the subject’s informed consent as approved by an IRB. The use of the VA biospecimens must be consistent with the subject’s informed consent and the approved research activity. For example, if the subject’s IRB-approved informed consent document stated that only de-identified biospecimens would be shared with other researchers as part of future research studies, an MTA cannot be used to share or transfer the subject’s identifiable VA biospecimens. Such a use would be in direct conflict with the subject’s IRB-approved informed consent document and what the subject consented to when the biospecimens were initially obtained as part of the research study.

An MTA can also involve sharing or transferring of VA biospecimens that were obtained with a waiver of informed consent as approved by an IRB. Also, an MTA could involve sharing or transferring of VA biospecimens collected or obtained by a VA Investigator as part of an exempt human subjects research activity or a non-human subject research activity. For example, a VA Investigator requested de-identified biospecimens from a University’s biorepository using a MTA to document the transfer and use. The VA Investigator had no access to the key or link which would allow the VA Investigator to associate the biospecimen with the subject’s identity. The research activity consists solely of analyzing the specimens for a specific biomarker. The VA Investigator’s activity would constitute non-human subject research.

Please note that an MTA does not create authority for use of the VA biospecimens; the use must be consistent with the approved research activity. Any use of identifiable biospecimens must also meet the applicable Privacy requirements.

Date Published: 2017-07-28

What should be in a MTA?

At a minimum, the following should be included in a MTA:

• A statement defining who the contributor and recipient of materials (biospecimens) are, including the Primary Investigator, laboratory director, pathologist, etc. and their institution or facility.
• A statement regarding what biospecimens will be transferred. This may be easier to reference in an appendix to the agreement.
• A statement that biospecimens will only be used for the specified research purposes.
• A statement that biospecimens will not be used in human subjects.
• A statement that biospecimens may carry infectious agents such as bacteria, viruses, etc. and should be handled by trained personnel following biohazard universal precautions. Refer to http://www.cdc.gov/niosh/topics/bbp/universal.html for more information.
• A statement that biospecimens must be destroyed or returned to the VA after a specific retention period. The MTA should specify which will be required by the recipient.
• A statement that biospecimens will not be labeled with any individually identifiable information and that no effort will be made to re-identify the participants they were collected from when sharing or transferring de-identified VA research biospecimens.
• A statement that the recipient will not make any attempt to sell, share or transfer any biospecimens unless permitted by the agreement. NOTE: Selling does not include a “fee for service” arrangement that some biobanks utilize as part of their business model, but this should be documented in the MTA.
• A statement that any publications will acknowledge the contribution or the source of the biospecimens. This may not be applicable to all situations.
• A statement that all relevant laws and regulations be followed. These may include federal and local regulations such as the Health Insurance Privacy and Portability Act or HIPAA and 38 CFR 16 and 45 CFR Part 46, where applicable.
• A statement regarding any patents or intellectual property that may be produced from the research on the biospecimens. NOTE: You should refer to your Technology Transfer Office or legal affairs team for specific language.
• The agreement must be signed by the appropriate signatory authorities for the institutions. The Recipient Investigator should sign as an acknowledgement.

Date Published: 2017-07-28

Can a MTA be used as a Data Use Agreement?

No. Biospecimens are not data. However, if data is also being sent with biospecimens, a combined Material Transfer Agreement/Data Use Agreement can be used. See VHA Handbook 1200.12 for information on Data Use Agreements.

Date Published: 2017-07-28

What if I am transferring biospecimens to a diagnostic testing laboratory? Do I still need to implement a MTA?

It depends upon the situation. The issue is what authority exists for the biospecimen to travel to the testing laboratory and if an agreement is needed to allow the biospecimens to go to the diagnostic testing laboratory.

Date Published: 2017-07-28

Do I need a separate MTA if I am sending biospecimens to a for-profit company who is sponsoring the study?

VA has created a guidance document called, “Guidance on Selection of the Appropriate CRADA Model” that describes when a Material Transfer CRADA is used and when a MTA is used. In some clinical studies requiring a clinical trial study CRADA, sending biospecimens to the for-profit collaborator is part of the IRB-approved protocol for which subjects are consented. In those types of studies, it is not necessary to have a separate MTA A MTA would not apply in this case. Refer to the Tech Transfer website, http://www.research.va.gov/programs/tech_transfer/default.cfm, for more information on CRADAs.

Date Published: 2017-07-28

Does VA have a template for MTAs?

Yes. The MTA templates are located at https://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm. In addition, VA often receives other MTAs from other non-VA entities which are reviewed by OGC STAR for legal compliance. Also, VA also can use the Uniform Biological Material Transfer Agreement (UBMTA) published in the Federal Register.

Date Published: 2017-07-28

What is a MTA?

A Material Transfer Agreement, or MTA, is a legally binding agreement that is used when biospecimens are shared or transferred. A MTA defines the rights and obligations of the providers and recipients of the biospecimens.

Date Published: 2017-07-28

Can email messages be sent by VA Investigators to recruit and communicate with VA subjects?

Yes. VA Investigators can use VA email to recruit prospective VA subjects and to communicate with VA subjects who have consented to participate in a VA research study as described in the IRB-approved research study. VA Investigators may not utilize their personal email accounts (e.g., Google) or university email accounts for research communications with prospective or consented VA subjects. The use of personal email account or the use of a personal email system to conduct official agency business is not allowed. No PII/PHI can be sent by a VA Investigator for VA research purposes to a prospective or consented VA subject by email unless the email is encrypted using a VA-approved encryption method. Your local ISO should review the encryption to ensure it meets all applicable requirements. If the message is not encrypted, ORD recommends that the email message be reviewed as part of IRB review process. The IRB should consult with the VA Facility’s Privacy Officer concerning privacy issues outside the scope of the human subject protection regulations.

Note: An external recipient of a VA RMS encrypted email requires enrollment in the VA’s external RMS system in order to open the email at the present time.

Date Published: 2017-07-28

Can text messages be used by VA Investigators to recruit and communicate with VA subjects?

Yes. Text messages can be used by VA investigators to recruit prospective subjects and to communicate with VA subjects who have consented to participate in a VA research study as described in the IRB-approved research study. VA Investigators may not utilize their own personal devices, such as personal cellphones, personal Instant Messages (IMs), or university owned devices to send and receive text messages with prospective or consented VA subjects. No PII/PHI or identifiers can be sent by a VA Investigator for VA research purposes to a prospective or consented VA subject using text messaging unless the text messaging system is encrypted using a VA-approved encryption method. As indicated above, the ISO and Privacy Officer should review these as part of the review of the protocol.

Date Published: 2017-07-28

What are examples of personally identifiable information (PII) that VA Investigators cannot send by emails or by text messaging unless the information is encrypted using a VA-approved encryption method?

Personally identifiable information (PII) is considered to be the same as VA Sensitive Information/Data. PII is any information about an individual that can reasonably be used to identify that individual that is maintained by VA, including but not limited to, education, financial transactions, medical history, and criminal or employment history and information which can be used to distinguish or trace an individual’s identity, such as name, social security number, date and place of birth, mother’s maiden name, telephone number, driver’s license number, credit card number, photograph, finger prints, biometric records, etc., including any other personal information which is linked or linkable to an individual. (VA Directive 6502)

For purposes of VA research, data which is considered to be PII cannot be sent electronically unless it is encrypted using a VA-approved encryption method. Examples of PII that CANNOT be sent via email unless encrypted include, but are not limited to, the following:

• Names (employee names are acceptable);
• All geographical subdivisions smaller than a State;
• Social Security Number;
• Names of Relatives, including the mother’s maiden name;
• Biometric records;
• Fax numbers;
• Electronic mail addresses;
• Any other unique identifying number, characteristic, or code (note this does not mean the unique code assigned by the investigator to code VA research data);
• Any Protected Health Information

In addition to the above list of identifiers described in the HIPAA Privacy Rule, ORD and VHA policy considers a code derived from an individual’s Social Security Number to be PII that should not be sent unless it is encrypted.

Additional information regarding sensitive data is described in other VA and VHA Handbooks, including, but not limited to, VA Handbook 6500 and VHA Handbook 1605.01.

NOTE: Even with encryption PII being sent to a non-VA entity requires legal authority to make the disclosure of VHA data.

Date Published: 2017-07-28

What are examples of protected health information (PHI) VA Investigators cannot send by emails or by text messaging unless the information is encrypted using a VA-approved encryption method?

The HIPAA Privacy Rule defines protected health information (PHI) as Individually-identifiable health information transmitted or maintained in any form or medium by a covered entity, such as VHA. For VA, PHI is considered a subset of PII and includes any health information, not just identifiers or demographics, maintained by VHA that has not been de-identified in accordance with the HIPAA Privacy Rule.

VA Investigators cannot send any PHI to a prospective subject or to a VA subject participating in a VA study unless the email or text message is encrypted using a VA-approved encryption method. The VA National Rules of Behavior require VA employees who access and use VA information or information systems to use VA-approved encryption to encrypt any email, including attachments to the email, which contains VA sensitive information before sending the email. For example, a VA Investigator cannot send the following recruitment email to a prospective subject with the following message unless the email is encrypted because PHI (in bold) is conveyed (in addition to ethical issues and IRB regulatory criteria involved in sending this type of recruitment email):

“Dear Sir,

You are being asked to participate in a research study because you have been recently diagnosed with Stage IV Lung Cancer. Please contact the research team at “AAA-BBB-CCCC”. In another example, a VA Investigator cannot send the following communication in unencrypted email or text message because the name of the study include information that indicates the VA subject’s medical diagnosis : “Dear Ms. X, This is a reminder that your next study visit for “Anxiety Reducing Strategies for PTSD Clients” occurs next Monday at 8:00 a.m. in Room 123. Please contact the research team at “AAA-BBB-CCCC” if you need to reschedule. We look forward to seeing you on Monday. Have a great day.” VA Investigators must be aware of the content of emails and text messages sent as part of the study procedures in a VA research study. The content of the unencrypted email cannot contain any sensitive information. VA Investigators should always consider how the content of the email or text message might compromise the subject’s privacy and confidentiality if the message was inadvertently retrieved by someone other than the intended prospective subject or VA subject participating in a VA study. A VA Investigator should not include in the electronic communication information that would allow the reader to conclude that the individual had a specific diagnosis or condition, such as including a signatory line that states, “Research Team for COPD Study”. VA Investigators should also not include links to websites in electronic communications that are publicly accessible and would allow the reader to conclude that the individual has a specific diagnosis or condition if the electronic communication was read by others.

Date Published: 2017-07-28

What should a VA Investigator do if she or he receives PII or PHI from a prospective subject or a VA subject by unencrypted email or text message?

Sending recruitment messages to a prospective subject or communicating with consented VA subjects using the recipient’s personal, university, or commercial email accounts should always convey that no PII should be sent by email or text messaging to the VA research team. If health information or PII/PHI needs to be conveyed to the VA research team, it cannot be sent using unencrypted email or text messaging. ORD recommends that a statement be included on any research email or text message stating the following: “Email [or texting] is not secure. Please do not reply back to this message with any personal information or personal health information. Please call INSERT #.

Even though it is not anticipated, there may be rare circumstances in which a prospective subject or a VA subject participating in a VA study sends PII or PHI as part of a response using the individual’s personal email or text messaging. The VA Investigator should either respond by telephone to the individual or respond using email or text messaging with redaction of any PII or PHI conveyed by the prospective subject or VA subject participating in a VA study. In addition, the VA Investigator should not forward the email to other VA employees without encrypting the email or test message.

For example, a prospective subject sends the following email to the VA research team after receiving a recruitment email brochure approved by the IRB of Record for the specific VA study using the email address on the IRB-approved electronic recruitment flyer:

“I am so excited to receive information about this research study. I would love to be in it. I just happened to see my physician this morning, and he placed me on Norvasc and Captopril and told me that I have worsening COPD, with an oxygen level of 72 and a carbon dioxide level of 56. Please help me understand what this means. I will also send you my labs when I get them.”

In the above example, no telephone number was provided by the prospective subject. The VA Investigator cannot respond back using unencrypted email if any PII/PHI is going to be included. Therefore, the VA Investigator could send back an email as follows:

“Our research team received your email indicating interest in the study. You also had questions about your health. Please give me a call at INSERT # at your convenience.”

Date Published: 2017-07-28

What is an example format for a study reminder to a VA subject?

Study reminders sent by a VA research team by email or text messages cannot contain any PII or PHI unless the communication is encrypted using a VA-approved encryption method. Study reminders can be sent by a VA research team without including information that would require encryption. The content should not include any information that would indicate the type of appointment or the specific location, or specific diagnosis or condition; the content must be reviewed by the IRB as part of the IRB approval of the VA research study.

For example, the following is a study reminder that could be sent without encryption because no sensitive data is included in the content:

“Reminder: You have a visit on May 4, 2016 at 8:30 a.m. Please call 111-222-3333 if you need to reschedule or have questions.”

This is an example of a study reminder which contains PII/PHI and cannot be sent without encryption:

“C70298 Study Reminder: You have an appointment with the C70298 Study team on May 11, 2016 at 8:30 a.m. in Room 115 on the 1st floor of the main hospital building. Please bring all unused study medication and your supplemental Albuterol inhalers to the study visit. Please call the Pulmonary Clinic at 111-222-3333 if you need to reschedule or have questions.”

Date Published: 2017-07-28

What are some considerations for an IRB evaluating a research study proposing to utilize email and/or text messages to recruit or communicate with VA subjects?

The use of VA email in a VA research study must be evaluated by the IRB. When research studies utilize email or text messaging, the IRB must review the content of standardized communications. Other considerations for the email or text messages include, but are not limited to, the following:

• The VA Investigator must employ measures to avoid disclosing the email addresses of potential research subjects or other consented subjects to others. Common techniques include the use of:

(a) Individually targeted messages (only one address in the “TO” line per message)
(b) Group targeted messages with all recipient email addresses in the “BCC” line”. NOTE: Sending a group message with all recipient email addresses in the “TO” or “CC” line is inappropriate as all recipients can see the email addresses of the group.

• The VA Investigator should use a standard “SUBJECT” line that does not indicate the name of the study or the name of the recipient or other individually unique identifier. For example, the “SUBJECT” line should contain wording that would be general in nature and not indicate that the individual is being recruited for a study. This will prevent others who may see the list of emails received but cannot open them from knowing that the individual is being recruited. For example, the “SUBJECT” line should not read, “VA Subjects needed for Study on Addiction in Health Care Providers”. SUBJECT lines cannot be encrypted.

• There should be a signature block for the person sending the email, including his or her contact information at the VA but the contact information cannot contain anything that would indicate the specific study. The VA Investigator’s non-VA contact information should not be included for a VA study. There should also be a name and VA contact information for a VA research staff member who would be able to answer questions related to the study (if different than the VA Investigator). No responses related to the study which includes PII/PHI can be sent using unencrypted VA email or text messaging by a VA Investigator or VA research team. In order to approach human subjects research requiring IRB approval, the IRB is required to determine that all of the IRB approval criteria are met, which includes equitable selection of subjects and if there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (38 CFR Part 16.111(a)(3) and (a)(7)). The IRB should consider how the contact information, such as email addresses for sending IRB-approved recruitment information, is being obtained by the VA Investigator for the study. Similar to IRB considerations for contacting prospective subjects by telephone for recruitment activities or obtaining follow-up information for VA subjects in a VA study or sending letters by mail, the IRB should also consider how many emails or text messages are sent to prospective subjects for recruitment purposes or to VA subjects participating in a research study. The IRB should evaluate whether the frequency and/or content is appropriate for the purpose of the research study or evaluate whether or not the frequency and/or content could be considered to be coercive or harassment by prospective subjects or VA subjects participating in a research study.

The IRB cannot approve an informed consent process which uses email or text messaging to document informed consent as described in VHA Handbook 1200.05. ORD permits informed consent for VA research to be obtained electronically, but the informed consent process and documentation must meet all requirements described in VHA Handbook 1200.05 as well as applicable VA requirements. Documentation of informed consent by email or text messages is not an example of consent which is obtained electronically permitted under VHA Handbook 1200.05, Paragraph 16(e)(2)(c). In addition, neither of these types of electronic communication can serve as a signed HIPAA authorization for use and disclosure of PHI for research purposes.

Date Published: 2017-07-28

Can a VA Investigator communicate research study information which includes personally identifiable information to a study recruiting VA employees using VA email?

VHA conducts numerous studies involving VA employees, and encrypted email using a VA approved encryption method can be used to communicate sensitive information, such as personally identifiable information, between a VA employee and a VA research team if approved by the IRB as part of its approval of the research study. However, it is important to remember that the privacy and confidentiality of VA employees who are asked to participate in VA research must be evaluated by the IRB when using email or text messaging, regardless of whether PII is being sent using encrypted VA email or unencrypted email is being sent by a VA research team member to VA employees.

The content of the message should not include any information that might compromise the employee’s privacy, position, or standing as a VA employee if others, such as the employee’s supervisor, were to know that he or she was being approached to participate in the project or has consented to be in a VA research study. VA employee email is not confidential and is subject to review by VA. Some VA employees routinely give permission to others (e.g., administrative assistants) to allow them to read the individual’s emails. VA also may be required to release VA employee emails under a FOIA request.

The IRB should consider whether or not additional privacy and confidentiality safeguards are needed when VA employees are recruited as VA subjects, regardless of whether or not email or text messaging is involved for the VA research study.

Date Published: 2017-07-28

Are VA Investigators required to keep copies of emails and text messages sent to and from VA subjects?

Emails and text messages sent and received by a VA Investigator and the VA research team are federal records subject to the VHA Record Control Schedule. Copies of the email communications and text messages sent and received by a VA Investigator and the VA research team must be maintained in accordance with the VHA Record Control Schedule (RCS 10-1) as part of local VA Investigator records.

Text messages may have unique issues for retention because they are not retrievable in the same context as email messages. However, the text messages sent and received in VA research must be printed or captured as part of VA’s record retention requirements. If they cannot be retained, then these forms of communication cannot be used.

Date Published: 2017-07-28

Can VA Investigators utilize My HealtheVet’s Secure Messaging system to recruit VA subjects in approved VA research studies?

VA Investigators cannot use My HealtheVet’s Secure Messaging system to recruit VA subjects.

Date Published: 2017-02-21

Can a research team continue to collect, use and disclose individual subject information on receipt of a revocation? Must the revocation be in writing or can the research team accept an oral revocation from the subject? If a subject withdraws informed consent, is that the same as a HIPAA revocation?

A research subject may revoke his/her Authorization at any time. The revocation must be in writing. An oral discussion between the subject and member of the research team does not revoke a HIPAA authorization. If the intent of the subject is to revoke, the principle investigator must provide a revocation form to the subject or request the subject’s revocation in writing. A revocation can be on any document. VHA researchers may use VAF 10-10116, Revocation of Authorization for Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research. The revocation is effective as soon as it is received, in writing, by the study’s Principal Investigator. A revocation of the HIPAA authorization is not the same as withdrawing from the Study.

As permitted by HIPAA, VHA may continue to use and disclose protected health information (PHI) that was obtained before the individual revoked his or her Authorization to the extent necessary to preserve the integrity of the research study. This permits VHA, as the HIPAA covered entity, to continue using the PHI as necessary to maintain the integrity of the research; for example, to account for a subject's withdrawal from the research study, to conduct investigations of scientific misconduct, or to report adverse events. For example, a VA Investigator has IRB approval and VA R&D Committee approval to conduct a clinical trial at a VA Facility that recruits Veteran patients with asthma. Each study subject’s participation in the study is approximately 2 years. One of the Veteran subjects who has participated in the study for 6 months informs the VA Investigator in writing that he or she is revoking the Authorization and withdrawing from the study. The VA Investigator is permitted to retain and analyze all study that was obtained and collected up to the date the Veteran subject revoked his or her authorization, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol.

However, it would not permit VHA to continue allowing a researcher to collect new or additional protected health information from any source for the approved study. In the above example, a Veteran subject revoked his or her Authorization before completing the study. The VA Investigator wishes to obtain additional information regarding the number of the Veteran subject’s hospitalizations for asthma exacerbations for the 18 months following the revocation of the HIPAA authorization since no direct contact with the Veteran subject is necessary. The information will be obtained through review of the VHA Health Record. This is not permitted once the Veteran subject revokes Authorization because there is no legal authority for the VA Investigator to access the Veteran subject’s VHA Health Record for research purposes. There is also no Authorization to collect and use this new additional protected health information.

VHA may only continue to disclose the PHI as necessary to maintain the integrity of the research, when legal authority exists under all applicable federal privacy laws and regulations, including the Privacy Act, 38 USC 7332 and 38 USC 5701. Consult with the facility Privacy Officer prior to making any disclosure of PHI for the study once the individual has revoked authorization.

Additional human research protection regulations apply to retaining and analyzing already collected data when a subject withdraws from the research or his or her participation is terminated by the Investigator of the research. The human research protection regulations applying to informed consent in the VA are found in the Common Rule (38 CFR Part 16). Unlike HIPAA, the Common Rule does not require a human subject consented to participate in a human subjects study to withdraw his or her informed consent in writing. VA follows OHRP’s interpretation of the Common Rule as allowing investigators to retain and analyze already collected data relating to any subject who chooses to withdraw from a research study or whose participation is terminated by an investigator without regard to the subject’s consent, provided such analysis falls within the scope of the analysis described in the IRB-approved protocol. This is the case even if the data includes identifiable private information about the subject. As long as a non-exempt human subjects research study continues to involve the use, study, or analysis of identifiable private information by the investigators, the research continues to involve human subjects and must undergo continuing review by an IRB at least annually (38 CFR 16.109(e)).

If the subject withdraws informed consent or is terminated from the study by the investigator, the investigator can no longer collect any additional data on the subject even if the subject has not revoked his/her authorization in writing.

FDA has also issued guidance regarding data retention when subjects withdraw from FDA-Regulated Clinical Trials: Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention when Subjects Withdraw from FDA-Regulated Clinical Trials. That guidance can be found at http://www.fda.gov/downloads/regulatoryinforamtion/guidances/ucm126489.pdf.

References: Authorization Required Statements (45 C.F.R. § 164.508(c)(2) and (c)(5)) https://privacyruleandresearch.nih.gov/authorization.asp and http://www.hipaasurvivalguide.com/hipaa-regulations/164-508.php

Withdrawal of Subjects from Research Guidance (2010): http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-withdrawal-of-subject/index.html

HHS FAQ: http://www.hhs.gov/hipaa/for-professionals/faq/316/if-a-research-subject-revokes-authorization-can-a-researcher-continue-using-information-obtained/index.html

FDA Guidance: Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention when Subjects Withdraw from FDA-Regulated Clinical Trials (2008): http://www.fda.gov/downloads/regulatoryinforamtion/guidances/ucm126489.pdf

Date Published: 2015-04-16

Who is a “non-affiliated individual?”?

“Non-affiliated individual” means an individual who has no discernable ties, ongoing relationship, or association with the VA facility (but see paragraphs 3 and 4 below). An immediate family member (parent, spouse, child, sibling) of an affiliated person may not be considered a “non-affiliated individual.”

Date Published: 2015-04-16

What does academic “affiliation” mean for the purposes of this Guidance document?

An “academic affiliate” means an academic institution that has a relationship for the purpose of education, research, or enhanced patient care with a VA facility documented by an executed Affiliation Agreement in conformance with VA requirements. In addition, special purpose agreements documented by a memorandum of understanding approved by the Chief Research and Development Officer may be developed in research and development (R&D) areas, such as health services or rehabilitation R&D.

Date Published: 2015-04-16

Are employees of the academic affiliate considered affiliated with VA for purposes of this Guidance document?

Employees of the academic affiliate are considered non-affiliated for purposes of determining membership eligibility on a VA IRB if they do not have an appointment (i.e., compensated, Intergovernmental Personnel Act (IPA), or WOC) at the VA, any discernable ties, ongoing relationship, or association with the VA.

Date Published: 2015-04-16

Are Veterans receiving care at the VA considered to be affiliated?

Veterans whose only relationship with VA is receiving care at a VA facility or receiving benefits from the Veterans Benefits Administration are not considered to be “affiliated” for the purpose of being an IRB member.

Date Published: 2015-04-16

Are Veterans who volunteer at the VA considered to be affiliated?

Individuals who perform occasional volunteer activities at VA without a WOC appointment are not considered “affiliated” for purposes of this Guidance document. However, those who hold a WOC appointment for volunteer activities other than IRB service are considered to be affiliated.

Date Published: 2015-04-16

Are VA retirees considered “affiliated” for purposes of this Guidance document?

Individuals who have retired from VA are considered affiliated for purposes of determining membership eligibility on a VA IRB only if they are receiving VA retirement benefits.

Date Published: 2015-04-16

What does receiving a WOC appointment mean?

A WOC is an individual that has an official VA appointment, but does not receive any salary or benefits from VA (38 U.S.C. §§ 513, 7405(a)(1)). This appointment may allow the individual to support VA’s research program in various capacities including, but not limited to, investigator, research coordinator, and administrator while at VA for a defined period of time.

WOCs are subject to all laws and regulations pertaining to government personnel, including, but not limited to, government ethics laws and standards of conduct and VHA’s credentialing and privileging policy. A WOC is considered a VA employee.

NOTE: A WOC may be an employee of a university affiliate or other nonprofit organization and is not under an IPA. An IPA is also a VA appointment that allows an individual to serve as a VA employee, therefore, an IPA does not require a WOC appointment.

Date Published: 2015-04-16

Should a nonaffiliated IRB member be given a WOC appointment?

A nonaffiliated VA IRB member should, but is not required to, obtain a WOC appointment. The WOC appointment provides the best protection from unexpected liability and the best likelihood for the Department of Justice (DOJ) to represent that individual as a VA "employee" and thus, be immune from personal liability for negligence. The WOC appointment for purposes of liability coverage does not change the affiliation status of the IRB member. NOTE: If a nonaffiliated IRB member chooses not to obtain a WOC appointment for purposes of being on the IRB, he/she is still bound to all VA requirements on confidentiality and conflict of interest.

[See chart in guidance document]

Date Published: 2015-03-09

What is required when collecting Pregnancy Information from or about Female Subjects who become Pregnant while Participating in VA Research

In the majority of studies conducted in the VA, pregnancy is not the focus of the research. In many research studies, particularly clinical investigations involving interventions with drugs or medical devices, the investigator or sponsor may want to obtain information about the progress of a pregnancy when a female subject becomes pregnant while participating in the research. In the majority of these studies, the female subject no longer receives the clinical intervention described in the IRB-approved protocol once the investigator is made aware of the female subject's pregnancy, but monitoring of the pregnancy for safety is requested or recommended by the sponsor of the study.

If a female subject who becomes pregnant is withdrawn from the research intervention portion of the study by a VA investigator, collection of any additional data by the investigator from the female subject or obtaining identifiable private information about her after she is withdrawn would constitute human subject research activities. A subject can be withdrawn solely from receiving the research intervention, remain in the study, and the investigator would be allowed to continue data collection and other follow-up activities if the data collection and follow-up activities are described in the protocol and informed consent approved by the IRB, the HIPAA authorization, and the subject does not revoke that portion of the informed consent and HIPAA authorization. Written authorization requirements for use and disclosure of protected health information must be met as described in VHA Handbook 1605.01 ("Privacy and Release of Information") and VHA Handbook 1200.05. When a subject is withdrawn from all aspects of the study by the subject's or investigator's choice, the subject's participation in that study ends and additional data and identifiable private information about that subject must not be collected or obtained.

Date Published: 2015-03-09

What is required when Collecting Pregnancy Information from or about Female Partners of Male Subjects Participating in VA Research

The majority of studies conducted in VA involve recruitment of male subjects. In research studies, particularly clinical investigations, the investigator may want to obtain information about the progress of a pregnancy if the female partner of a male Veteran subject becomes pregnant during the interval when the male subject is participating in a VA research study.

VA applies the Common Rule to all human subjects research which is approved as VA research. Collection of data in the research through intervention or interaction with the female partner or obtaining identifiable private information about the female partner constitutes human subjects research. The female partner becomes a human subject according to the Common Rule and is given protections as a human subject as required in 38 CFR §16 and VHA Handbook 1200.05. In such cases, the IRB-approved protocol must include provisions for collecting information from the pregnant female partner of the male subject enrolled into the research. Informed consent as approved by the IRB must be obtained by the investigator from the female partner prior to the collection of any data by the investigator from the female partner or obtaining identifiable private information about her unless the IRB has waived informed consent in accordance with criteria described in 38 CFR § 16.116(c) or 38 CFR §16.116(d). Written authorization for use and disclosure of protected health information must be obtained from the female partner as described in VHA Handbook 1605.01: Privacy and Release of Information.

Date Published: 2015-03-09

What is required when Collecting Information About the Newborn Infant in VA Research?

When a VA investigator conducting human subjects research collects identifiable private information about the newborn infant of subject enrolled in VA research, the infant is a human subject, and the investigator is conducting VA research involving children. The IRB-approved protocol must include provisions for collecting information about the newborn infant. Informed consent as approved by the IRB and obtained from the adult subject(s) must contain sufficient information about the data to be obtained for the newborn. Written authorization for use and disclosure of protected health information must be obtained as described in VHA Handbook 1605.01: Privacy and Release of Information. The VA facility director must approve participation of children in the research prior to collection of data about the newborn infant following IRB review and approval in accordance with VHA Handbook 1200.05 requirements.

Date Published: 2015-03-09

What should the IRB Consider When Collecting Data on Pregnancy Progress and Outcomes of Pregnancy in VA Research?

When VA research involves collecting data from or about pregnancy and pregnancy outcomes, the IRB must still ensure that subjects' ethical rights are protected. VHA follows 45 CFR §46.204 requirements for including pregnant women in VA research. IRBs are not expected or required to review studies using the criteria described in 45 CFR §46.204 simply because the study involves women of child-bearing potential. However, once the reviewing IRB is made aware that information about a subject's pregnancy is being obtained in a VA study, the reviewing IRB must ensure that:

1. the IRB-approved protocol addresses the data collection procedures for obtaining data about the progress of the pregnancy and pregnancy outcomes (live birth with or without birth defects, stillborn, or aborted fetus);

2. informed consent has been obtained from the adult subject to obtain information about the progress of the pregnancy and pregnancy outcomes unless the IRB has waived informed consent in accordance with criteria described in 38 CFR §16.116(c) or 38 CFR §16.116(d);

3. the data collection involving the pregnant female subject described in the IRB approved protocol meets the conditions described in 45 CFR §46.204; and

4. the data collection involving the newborn infant described in the IRB-approved protocol meets 45 CFR §46 Subpart D requirements for research activities not involving greater than minimal risk (45 CFR §46.404).

Date Published: 2015-03-09

What is required when obtaining VA Facility Director approval for collecting data about the newborn infant?

When identifiable private information or de-identifiable information is collected about a newborn infant in VA research, the newborn infant is a research subject who is also a child. Following IRB, other applicable subcommittees, and R&D Committee approvals, the VA Facility Director must approve this activity which constitutes VA research involving children as research subjects. This VA Facility Director approval should be in the investigator’s study files and in the R&D file in the Research Office.

VA Facility Director approval for VA research involving children does not have to be obtained until the research involves children. There is no ORD requirement to obtain VA Facility Director approval for research involving children in VA research if a protocol includes women of child-bearing potential unless an event occurs in which data about the newborn infant from a female subject or the pregnant partner of a male VA subject will be collected in VA research.

If the research activities involving the newborn infant consist of data collection through review of records (no intervention or interaction with the infant), considerations that the VA Medical Center Director may evaluate during the approval process such as procuring liability insurance to allow collection or data or considering whether the VA Facility is able to respond to pediatric emergencies is not applicable because the research activity consists of data collection in the absence of interventions or interactions. Additional guidance from ORD issued to assist IRBs, R&D Committees, and VA Facility Directors in their review and approval of VA research that meets the definition of children’s research is available at http://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf

Date Published: 2015-03-09

What is required when obtaining VA Facility Director Certification for Collecting Data about the Female Subject who Becomes Pregnant or the Pregnant Partner of a Male Subject in VA Research?

When identifiable private information is collected about or from the female subject who becomes pregnant or the pregnant partner of a male subject, VA research involving pregnant women is being conducted. Following IRB, other applicable subcommittee, and R&D Committee approval, the VA Facility Director is required to certify that the Medical Facility has sufficient expertise in women’s health to conduct this activity. This VA Facility Director approval should be in the investigator’s study files and in the R&D file in the Research Office.

If the research activities with collecting pregnancy progress and pregnancy outcome data involves minimal risk activities (e.g., no obstetric interventions being done at the VA Facility to collect data), considerations that the VA Medical Center Director may evaluate as part of the certification process such as ensuring that the VA facility is able to respond to obstetric emergencies is not applicable because the research activity is not associated with obstetric emergencies.

Date Published: 2015-03-09

How can Non-VA Research Activities be Advertised in VA Facilities?

The posting of flyers, recruiting documents, or advertisements is governed and approved by the local VA facility. The VA Facility Director is responsible for ensuring that a formal process is in place for this activity. Research offices should:

1.Review outside requests for the posting of recruiting documents, flyers, and advertisements to ensure that the research is relevant to Veterans and the missionof VA and will not impede current VA research activities.

2.Ensure that recruiting documents, flyers, and advertisements for research that is not VA research and will not be conducted at the VA include a clear and legible disclaimer statement that the research is not VA research, will not be conducted by VA, has not been reviewed by VA’s Institutional Review Board, and is not endorsed by VA. VA is not responsible for any costs incurred by a Veteran if the Veteran enters the study as a research subject. The announcement is being provided for information only.

3. Evaluate whether or not the non-VA research activity should be submitted as a VA research activity (e.g., the Principal Investigator for the proposed non-VA activity is also a VA employee (i.e., dual appointee) wishing to recruit subjects at the VA Facility or could conduct some or all of the research at the VA).

4. Follow the local process for posting flyers or advertisements within the facility. Recruiting documents, flyers, and advertisements for research that is not VA research should be reviewed for relevance to Veterans and inclusion of the disclaimer. They should not be reviewed by the IRB or the Research Committee as if they were VA research. Members of these committees may be asked for input as appropriate.

Date Published: 2015-03-09

Can the non-VA Research Activities be Advertised on the VA Facility’s Facebook page?

No. VA has approved the use of different types of social media, such as VA blogs, Facebook, Twitter, Flickr, and Yammer, to promote the mission, goals, and objectives of VA. When VA is advertising a non-VA study on the VA Facebook pages, it is promoting an activity that is not a VA activity. Hundreds or even thousands of people, including those outside of the intended audience, may see this advertisement. These Facebook posts advertising non-VA research activities can be perceived in a different context than that which was intended. Use of the Facebook pages to promote recruitment into non-VA research activities is not consistent with VA Directive 6515: Use of Web-Based Collaboration Technologies and is not permitted.

Date Published: 2014-10-22

How does the IRB determine the frequency for continuing review?

VHA Handbook 1200.05 requires that the IRB must establish written standard operating procedures (SOPs) that include, but are not limited to, procedures for conducting initial and continuing review of research and reporting findings and actions to the investigator and to the Research and Development (R&D) Committee. The Common Rule (38 CFR Part 16) also requires that the IRB conduct continuing review at intervals appropriate to the degree of risk but not less than once per year. The IRB should decide the frequency of continuing review for each research project necessary to ensure the continued protection of the rights and welfare of research subjects. More frequent review (i.e., more frequently than once per year) may be appropriate when the risks to subjects warrant more frequent reassessment. The IRB should consider factors such as the following when deciding on an appropriate interval for continuing review and these factors should be outlined in the IRB’s standard operating procedures:

• The nature of any risks posed by the research project;
• The degree of uncertainty regarding the risks involved;
• The vulnerability of the subject population;
• The experience of the investigators in conducting this type of research;
• The IRB’s previous experience with the investigators (e.g., compliance history, previous problems with the investigator obtaining informed consent, or prior complaints from subjects about the investigator);
• The projected rate of enrollment; and
• Whether the research project involves novel interventions.

In addition to specifying a time interval, the IRB may specify a subject enrollment number as a threshold for determining when continuing review is to occur. For example, at the time of initial review and approval of a high-risk clinical trial, the IRB might require that continuing review occur either in 6 months or after 5 subjects have been enrolled, whichever occurs first.

The IRB must communicate the project’s expiration date to the PI in writing. In addition, the IRB should have policies and procedures in place to assure sufficient time for the PI to submit the continuing review documents, for the IRB to review them, and to receive approval prior to that expiration date. These procedures may include sending reminders to the PI at intervals prior to the approval expiration date.

Date Published: 2014-10-22

What materials must the PI submit to the IRB for continuing review?

IRBs should have written procedures for continuing review that require investigators to submit the following documents, as applicable, if not already available to the IRB as part of the existing IRB records for the research:

• A brief project summary (this could be included as part of a progress report described in the next bullet, provided as a separate document, or be addressed by referencing other documents made available to the IRB);
• A progress report that includes the following: o The number of subjects accrued since the IRB’s initial review and the last IRB continuing review approval (if the project has undergone a prior continuing review approval). For multicenter research studies, the number of subjects accrued at the local institution and the number accrued study-wide, if available should be included. It is suggested that IRBs clearly indicate to investigators whether or not progress reports should categorize subjects who undergo screening procedures requiring written informed consent or a waiver of documentation of informed consent as accrued subjects or withdrawn subjects. ORD would not consider subjects who have given informed consent to have screening procedures done for a research project and subsequently were unable to meet the inclusion criteria for continued participation in the project (or met an exclusion criteria) as accrued subjects that should be reported at continuing review. ORD would also not consider these individuals to be subjects who have withdrawn from the study for purposes of reporting at continuing review.

o A brief summary of any amendments to the research approved by the IRB since the IRB’s initial review or the last continuing review.
o Any new and relevant information, published or unpublished, since the last IRB review, especially information about risks associated with the research.
o A summary of both any unanticipated problems and available information regarding adverse events (the amount of detail provided in such a summary will vary depending on the type of research being conducted and the level of risk; in many cases, such a summary could be a brief statement that there have been no unanticipated problems and that adverse events have occurred at the expected frequency and level of severity as documented in the research protocol, the informed consent document, and investigator’s brochure, if applicable).
o A summary of any withdrawal of subjects from the research since the last IRB review, and the reasons for withdrawal, if known (include those lost to follow-up, voluntary withdrawals, or withdrawals by the investigator.
o A summary of any complaints about the research from subjects or others since the last IRB review.

The latest version of the IRB-approved protocol and sample informed consent document(s);
Any proposed modifications to the informed consent document or protocol;
For FDA-regulated research, the current Investigator’s Brochure, if available, including any modifications; and
Any other significant information related to subject risk, such as the most recent summary from any DSMB or DMC monitoring the research, if available. Even when the DSMB or DMC has identified no problems during its review and simply recommended continuation of the research study as designed, it may be useful for the IRB to be informed of this recommendation.

Date Published: 2014-10-22

What does the IRB review during continuing reviews?

The IRB reviews all of the materials submitted and determines if any of the material reviewed would change the determination that all criteria for approval have been met with the working presumption that the research, as previously approved, continues to satisfy all of the approval criteria:

• Risks to subjects are minimized (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
• Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result;
• Selection of subjects is equitable;
• Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, and appropriately documented in accordance with, and to the extent required by, VHA Handbook 1200.05;
• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data;
• Appropriate safeguards are included to protect subjects likely to be vulnerable to coercion or undue influence; and
• When the research involves pregnant women, fetuses, or neonates; prisoners; or children, the research satisfies the additional requirements for IRB approval.

The IRB should determine if there is any new information provided by the investigator, or otherwise available to the IRB, that would alter the IRB’s prior determinations, particularly with respect to the IRB’s prior evaluation of the potential benefits or risks to the subjects. The IRB also should assess whether there is any new information that would necessitate revision of the protocol and/or the informed consent document. At the time of continuing review, IRBs have the authority to disapprove or require modifications in (to secure re-approval of) a research activity that does not meet the above criteria. If research does not satisfy all of the above criteria, the IRB must require changes that would result in the research satisfying these criteria, defer taking action, or disapprove the research.

The IRB should review a copy of the sample informed consent document submitted by the investigator to verify that the document contains the most accurate, up-to-date information about the research. If the IRB waived the requirement for the investigator to obtain a signed consent form for some or all subjects, the IRB should assess the accuracy of the content of the information being provided to subjects orally and of any written statement regarding the research that is being provided to subjects. If there is new information that should be considered a significant new finding, the IRB should determine if this should be added to the consent form and communicated with subjects who have already been enrolled.

It also may be appropriate for the IRB at the time of continuing review to confirm that any provisions under the previously approved protocol for monitoring the research data to ensure safety of subjects have been implemented and that no modifications are needed (e.g., the IRB could require that the investigator provide a report from the monitoring entity described in the IRB-approved protocol).

At the time of continuing review, the IRB should ascertain whether enrollment is consistent with the planned number of subjects described in the IRB-approved protocol. A marked difference between the actual and expected rates of enrollment may indicate an issue with the research project that requires further evaluation. The IRB also needs to consider at continuing review whether the enrollment issues impact potential subject safety issues.

The IRB should review the number of subjects who discontinued their participation and the summary of the reasons for the withdrawals, if known. This information may shed light on issues related to the conduct of the research. For example, a high rate of subject withdrawal secondary to unexpected serious adverse events may indicate that the risks of the research are greater than initially expected. The IRB will need to evaluate whether the IRB approval criteria in 38 CFR 16.111 are still met and/or whether modifications need to be made for continued approval of the research.

Date Published: 2014-10-22

When can the IRB use expedited procedures for continuing review?

When continuing review of research is conducted under an expedited review procedure, the review must be conducted by the IRB chairperson or one or more experienced reviewers designated by the IRB chairperson from among the IRB members. The IRB must have procedures in place to ensure that no IRB member participates in the expedited review of research in which the member has a conflicting interest, except to provide information requested by the chairperson or his/her designee(s). The IRB chairperson or IRB members designated by the chairperson only can approve or require modification in (to secure approval of) research, but may not disapprove research using the expedited procedures. Disapproval of a research project at the time of continuing review can only occur after review by the IRB at a convened meeting, not by the expedited review process. All IRB members must be advised of research that has been approved under an expedited review procedure.

In general, a research study that was eligible for initial review under an expedited review procedure (met one of the expedited review categories, and involved no more than minimal risk) will qualify for an expedited review procedure at the time of continuing review. However, IRBs should be aware that a research study previously approved under an expedited review procedure in some circumstances will need to undergo continuing review by the IRB at a convened meeting. For example, the investigator at the time of continuing review may propose changes to the research project that involve the addition of activities that do not fall within the scope of any of the categories of research activities eligible for an expedited review procedure.

Research projects not initially eligible for expedited review may become eligible under the following circumstances:

• A research project previously approved by the IRB at a convened meeting progresses to the stage where all of the remaining human subjects research activities involve no more than minimal risk to the subjects and fall within the scope of one or more of expedited review categories (2) through (7).
• Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; OR Where no subjects have been enrolled and no additional risks have been identified; OR Where the remaining research activities are limited to data analysis. (See Expedited Review Category 8)
• Research previously approved by the IRB at a convened meeting that meets the following conditions: (i) The research is not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE); (ii) Expedited review categories (2) through (8) do not apply to the research; (iii) The IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk to the subjects; and (iv) No additional risks of the research have been identified. (See Expedited Review Category 9)

Date Published: 2014-10-22

What happens if there is a lapse of IRB approval?

The regulations at 38 CFR Part 16 make no provision for any grace period extending the conduct of research beyond the expiration date of IRB approval. A lapse in IRB approval of research occurs whenever an investigator has failed to provide continuing review information to the IRB or the IRB has not conducted continuing review and re-approved the research by the expiration date of IRB approval. If approval expires:

(1) The IRB is responsible for promptly notifying the investigator.
(2) The investigator must:
(a) Stop all research activities including, but not limited to, enrollment of new subjects; analyses of individually identifiable data; and research interventions or interactions with currently participating subjects, except where stopping such interventions or interactions could be harmful to those subjects; and
(b) Immediately submit to the IRB Chair a list of research subjects who could be harmed by stopping study procedures. Within two business days, the IRB Chair, with appropriate consultation with the facility Chief of Staff, determines if subjects on the list may continue participating in the research interventions or interactions.
(3) Once the study approval has expired, the IRB should complete the continuing review as soon as possible after the PI has submitted all required documents. The IRB should document why the lapse in IRB approval occurred, and, if appropriate, any corrective actions that the investigator, institution, or IRB is taking to prevent any such lapse of approval of the project from occurring again in the future.

When continuing review of a research project does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. This is not considered to be a suspension or termination of IRB approval. Therefore, such expirations of IRB approval do not need to be reported to ORO or OHRP. However, if the IRB notes a pattern of non-compliance with the requirements for continuing review (e.g., an investigator repeatedly or deliberately neglects to submit materials for continuing review in a timely fashion), the IRB should determine whether such a pattern represents serious or continuing noncompliance that needs to be reported to appropriate institutional officials (see VHA Handbook 1058.01).

Date Published: 2014-10-20

Under what circumstances can research involving children be conducted in VA?

The research is relevant to the health of Veterans, or o is directly relevant to VA’s role as a health care provider in a period of local or national emergency, or
o supports the mission of another Federal agency (e.g., DoD or NIH) through an interagency agreement or similar mechanism.

• The research represents no greater than minimal risk as determined by the IRB if the research requires IRB approval.
• The research could not be done if children or their biological specimens/data were not entered in the research.
• The IRB reviewing the research has appropriate membership to represent children’s interests and pediatric expertise.
• The IRB reviewing the research has specific SOPs regarding children in research.
• The research meets all requirements in 45 CFR 46, Subpart D, Additional Protections for Children Involved as Subjects in Research, Sections 46.401 through 46.404, and 46.408.
The VA facility Director certifies that the facility is able to respond to pediatric emergencies if the research includes interactions with children at the VA facility.

Date Published: 2014-10-20

What information should be provided in a research proposal and/or review materials that involve children in research?

For studies involving the use of pre-existing children’s biological specimens or data:

o A description of the relevance of the study to the health of Veterans.
o Documentation that the institution that collected the children’s research biological specimens or data had an active FWA at the time the research was conducted.
o Documentation that the research under which children’s biological specimens or data were collected was approved by an Institutional Review Board under the requirements of 45 CFR 46 Subpart D.
o Documentation that authority exists to reuse the children’s biological specimens or data in VA approved research. Such documents may include the consent, waiver of consent, or protocol from the study under which the specimens were collected.


• For research involving interaction with living children as research subjects:

o A description of the relevance of the study to the health of Veterans
o Justification for enrolling children or their specimens/data into the study.
o A copy of the study protocol, the informed consent form, the assent document (if applicable), and HIPAA authorization. The informed consent document signed by the parent or guardian is the vehicle for parent or guardian permission. Provisions for permission by parents or guardians should be documented in accordance with, and to the extent required by, 38 CFR 16.117.
Documentation of any additional safeguards that have been incorporated into the clinical or research site where children will be studied.
• Information on the funding source for the research.

Date Published: 2014-10-20

What should the VA IRB of record review and document for approving research involving children?

Review the risks of the study and determine that the study is no more than minimal risk.
• Review the research proposal and additional materials to determine that all criteria for IRB approval have been satisfied in accordance with VHA Handbook 1200.05.
• Review and approve consent documents in accordance with VHA Handbook 1200.05, or a waiver of consent or documentation of consent if these criteria are met.
• If the study involves use of pre-existing biological specimens or data, the research under which it was collected was reviewed by an IRB meeting all requirements under 45 CFR 46, Subpart D,
If the study involves use of pre-existing biological specimens or data, review the consent or authorization under which these specimens or data were collected and determine whether there is the proper authority for reuse.
• The study meets all requirements in 45 CFR 46, Subpart D, Additional Protections for Children Involved as Subjects in Research, Sections 46.401 through 46.404, and 46.408.
• Document in the minutes the discussion regarding level of risk, the informed consent and assent forms, the investigators’ qualifications to conduct research involving children, and any additional safeguards incorporated into the protocol.

Date Published: 2014-10-20

What should the R&D Committee review and document for research involving children?

The proposed research is relevant to the VA’s mission and the care of Veterans.
• There is scientific merit to the research proposed.
• There are adequate protections for participating human subjects (including privacy and confidentiality), and adequate safety measures for research subjects and personnel engaged in the research.
• The required resources are available and the locations are appropriate where the research will be conducted.
• The research investigator and research team are qualified to conduct the study.
• All appropriate subcommittee approvals have been obtained.

Date Published: 2014-10-20

What are the requirements for the facility Director memo of approval for research involving children?

CRADO approval is not required for a VA investigator to conduct VA research involving children. However, the facility Director should approve the conduct of such research before it is initiated.
• The facility Director should review the minutes of the VA IRB and R&D Committee meeting at which the protocol was approved to ensure that all criteria in item #1 of this guidance were satisfied.
• If the study includes an interaction with children at the VA facility, the VA facility Director should certify that the facility is able to respond to pediatric emergencies.
• If the sponsor of the research is not VA, the facility Director makes certain that the sponsor of the research has procured appropriate liability insurance.
• The memo documents for the record that the facility Director is aware of and approves the request for his/her facility to participate in the proposed research that includes children. The memo should be kept with the R&D file in the Research Office and a copy should be in the investigator’s files.

Date Published: 2014-10-20

Under what circumstances can international research be approved in VA?

The research should be relevant to VA’s mission and the care of Veterans, or
o is directly relevant to VA’s role as a health care provider in a period of local or national emergency, or
o supports the mission of another Federal agency (e.g. DoD or NIH) through an interagency agreement or similar mechanism

• There should be adequate protection of human subjects (including privacy and confidentiality), and the implementation of adequate safety measures for research subjects and personnel.
• There should be appropriate security of VA data and VA sensitive information and storage of data and specimens in accordance with all applicable VA requirements.
• The investigators should comply with the applicable VA policies related to the identification and resolution of conflicts of interest of research personnel.
• All data should be obtained in accordance with international ethics rules and regulations pertaining to human research subjects and consistent with FR Vol. 70, No. 57, pp15322-15327, March 25, 2005 “Protection of Human Subjects, Proposed Criteria for Determinations of Equivalent Protections”.
• All international sites should hold an international Federal Wide Assurance (FWA).
• The research should be approved by the IRB or Research Ethics Board of the participating site(s) that are listed on the international FWA.

Date Published: 2014-10-20

What information should be provided in a research proposal and/or review materials that involve international site(s)?

Rationale for conducting the research at an international site(s), including why it cannot be conducted at a VA facility or within the United States. If the research involves a partnership between the VA and an international site, the rationale for this partnership and its benefits to the VA and the U.S. veteran population should be discussed.
• For each domestic and international site, any financial arrangements including funding source, any type of payment to subjects, and financial arrangements involving the research site and local investigators at the research site.
• Discussion of each site in the foreign country(ies) including the foreign investigator(s), the location(s), and a description of the facility(ies) where the research will be conducted.
• Any research assurances that are in place at the international site(s), including an International (Non-U.S.) Assurance issued by Office of Human Research Protections (OHRP).
• Copy(ies) of all approvals required by the foreign country(ies) and institution(s). Include information on the IRB or ethics board or other review board that has been established to ensure the ethical conduct of the research and any stipulations of the board(s) that were required to be addressed prior to the initiation of the research in that country.
• Information on how the U.S. VA IRB of record and the foreign IRB decisions will be communicated and reconciled if necessary.
Information on VA’s liability in relationship to the conduct of the research including a discussion on care for research-related injuries and any compensation available for subjects or others at the site because of research-related injuries.
• A plan for conducting oversight of the research to ensure ethical conduct, compliance with all applicable regulations, and validity of the data. The plan should include oversight by any foreign country or entity.
• Frequency and content of monitoring reports, including information on who will review the reports and make any determinations regarding safety of subjects and compliance with applicable regulations.

Date Published: 2014-10-20

Are there additional requirements for research involving human subjects from the international site(s)?

Human Subjects Involvement and Characteristics. Describe the proposed involvement of human subjects in the Research Design and Methods section. Describe the characteristics of the subject population, including their anticipated number, age range, and health status. Identify the criteria for inclusion or exclusion of any subpopulation. Explain the rationale for the involvement of special classes of subjects, such as pregnant women, institutionalized individuals, or others who may be considered vulnerable populations.
• Sources of Materials if Other than the Research Subject Used in the Protocol.
o Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data, including information on research material that is obtained about deceased individuals or that is de-identified. Indicate whether the material or data will be obtained specifically for research purposes, or whether use will be made of existing specimens, records, or data.
o If the materials are obtained for research purposes, explain how they will be collected, which ethics review body(ies) reviewed the collection and use of the materials, and by what standards.
o If the material will be or has been collected for non-research purposes, describe the circumstance or reason for the collection.

• Potential Risks. Describe the potential risks to subjects (physical, psychological, social, legal, or other) and their likelihood and seriousness to the subjects. Differentiate therapeutic risk from research risk as follows: o Therapeutic risk is the risk or potential risks associated with an intervention that is required for medical care, but occurs as part of the research. An example is an endoscopy that was required for medical follow-up of a specific illness.
o Research risk is associated with an intervention that is done only for research purposes regardless if it is an experimental intervention or a commonly used intervention, for example, an extra endoscopy. Where appropriate, describe alternative treatments and procedures, including the risks and benefits of the alternative treatments and procedures to participants in the proposed research.

• Recruitment and Informed Consent. Describe plans for the recruitment of subjects and the process for obtaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.
• Protection Against Risk. Describe the planned procedures for protecting against or minimizing potential risks, including risks to confidentiality, and their likely effectiveness. Where appropriate, discuss plans for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. For interventional studies, describe the plan for subject data and safety monitoring.
• Potential Benefit of the Proposed Research to the Subject and Others. Discuss the potential benefits of the research to the subjects and others, including why the risks are reasonable in relation to the anticipated benefits.
• Importance of the Knowledge to Be Gained. Discuss the importance of the knowledge to be gained as a result of the proposed research, including why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

Date Published: 2014-10-20

What should the VA IRB of record review and document for international site participation?

The VA IRB of record should review the research proposal and additional materials to determine that all criteria for IRB approval have been satisfied in accordance with VHA Handbook 1200.05.
• Review and approve consent documents in accordance with VHA Handbook 1200.05, or waiver of consent or documentation of consent if these criteria are met.
• Assure that appropriate research assurances are in place at the international site(s), including an International (Non-U.S.) Assurance issued by Office of Human Research Protections (OHRP), and that all approvals are obtained prior to initiating the research at those sites and any stipulations of the board(s) that were required to be addressed prior to the initiation of the research in that country.
• If appropriate, the IRB should ensure that mechanisms are implemented to ensure appropriate management, reduction, or elimination of potential, actual, or perceived conflicts of interest related to all aspects of the research, including financial interests, clinical roles (for example, investigator-patient relationships), and other professional, institutional, or personal roles.
• Level of risk including risk for the conduct of the research at the international site when the research involves living individuals.

Date Published: 2014-10-20

What should the R&D Committee review and document for international site participation?

The proposed research is relevant to the VA’s mission and the care of Veterans.
• There is scientific merit to the research proposed.
• There are adequate protections for participating human subjects (including privacy and confidentiality), and adequate safety measures for research subjects and personnel engaged in the research.
• The required resources are available and the locations are appropriate where the research will be conducted.
• The research investigator and research team are qualified to conduct the study.
• All appropriate subcommittee approvals have been obtained.

Date Published: 2014-10-20

What are the requirements for the facility Director memo of approval?

CRADO approval is not required for a VA investigator to conduct VA research involving international research activities unless it is CSP research. However, the facility Director should approve the conduct of such research before it is initiated. The facility Director should review the minutes of the VA IRB and R&D Committee meeting at which the protocol was approved to ensure that all criteria in item #1 of this guidance were satisfied.
• The memo documents for the record that the facility Director is aware of and approves the request for his/her facility to participate in the proposed international research, and concurs that the part of the research proposed for the international site including the collection of human biological specimen and data derived from human subjects could not be done within the VA or within the United States. The memo should be kept with the R&D file in the Research Office and in the investigator’s file.
• If the research proposal is to be submitted for funding through ORD, the facility Director memo may be submitted with other “Just-in-time” documentation.

Date Published: 2014-10-20

What is required for Cooperative Studies Program (CSP) research involving inernational research?

For CSP multi-site projects involving international research, review of all required information and approvals will occur during the CSP review process. If the CSP project is approved, the Director, Clinical Science Research & Development (CSR&D) will request the required permission from the CRADO or designee. For CSP Coordinating Center involvement in international research that does not undergo a CSP review process, the CSP Coordinating Center should submit a request to the CRADO through the Deputy Director, CSP. Note: For CSP studies the memorandum from the facility director of the performance sites is not required.

Date Published: 2014-10-20

Under what circumstances can research involving pregnant women be conducted in VA?

The research is relevant to the health of Veterans, or
o is directly relevant to its role as a health care provider in a period of local or national emergency, or
o supports the mission of another federal agency through an interagency agreement or similar mechanism.
• The IRB reviewing the research has appropriate membership to represent pregnant women’s interests and obstetric expertise.
• The IRB reviewing the research has specific SOPs regarding pregnant women in research.
• The research meets all requirements in 45 CFR 46, Subpart B, Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, Sections 46.203 through 46.207 including the following ethical and scientific criteria:

o where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on non-pregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
o the risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or fetus. If there is no such prospect of benefit, then the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means;
o any risk is the least possible for achieving the objectives of the research.

• The VA facility Director certifies that the facility is able to respond to obstetric emergencies if the research involves an intervention greater than minimal risk in pregnant women at the VA facility.

Date Published: 2014-10-20

What information should be provided in a research proposal and/or review materials that involve pregnant women in research?

A description of the relevance of the study to the health of Veterans
• Justification for entering pregnant women into the study.
• A copy of the study protocol, the informed consent form and HIPAA authorization.
• Documentation of any additional safeguards that have been incorporated into the clinical site where pregnant women will be studied.
• Information on the funding source for the research.

Date Published: 2014-10-20

What must the VA IRB of record review and document for approving research involving pregnant women?

Review the research proposal and additional materials to determine that all criteria for IRB approval have been satisfied in accordance with VHA Handbook 1200.05.
• Review and approve consent documents in accordance with VHA Handbook 1200.05, or a waiver of consent or documentation of consent if these criteria are met.
• The study meets all requirements in 45 CFR 46, Subpart B, Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research, Sections 46.203 through 46.207.
• Document in the minutes the discussion regarding level of risk, the informed consent, the investigators’ qualifications to conduct research involving pregnant women, and any additional safeguards incorporated into the protocol.
• If appropriate, the IRB must ensure that mechanisms are implemented to ensure appropriate management, reduction, or elimination of potential, actual, or perceived conflicts of interest related to all aspects of the research, including financial interests, clinical roles (for example, investigator-patient relationships), and other professional, or personal roles.

Date Published: 2014-10-20

What must the R&D Committee review and document for research involving pregnant women?

The proposed research is relevant to the VA’s mission and the care of Veterans.
• There is scientific merit to the research proposed.
• There are adequate protections for participating human subjects (including privacy and confidentiality), and adequate safety measures for research subjects and personnel engaged in the research.
• The required resources are available and the locations are appropriate where the research will be conducted.
• The research investigator and research team are qualified to conduct the study.
• All appropriate subcommittee approvals have been obtained.

Date Published: 2014-10-20

What are the requirements for the facility Director memo of approval for research involving pregnant women?

• The facility Director must review the minutes of the VA IRB and R&D Committee meeting at which the protocol was approved to ensure that all criteria in item #1 of this guidance were satisfied.
• If the study includes an intervention greater than minimal risk with pregnant women at the VA facility, the VA facility Director must certify that the facility is able to respond to obstetric emergencies.
• The memo documents for the record that the facility Director is aware of and approves the request for his/her facility to participate in the proposed research that includes pregnant women.

Date Published: 2013-02-08

What is the IRB required to do when there is a change in the study team member named within a protocol and/or informed consent form?

In a protocol or informed consent form, study team members are generally identified by name or by title. If a study team member is identified by name in the IRB-approved protocol and/or informed consent form, a replacement or termination of that member’s role constitutes a change in the protocol and/or informed consent form. Therefore, such a change requires IRB review and approval. For example, if an IRB-approved protocol specifically identified the name of a medical monitor and later another individual was identified to replace him or her, the protocol would require an amendment reflecting the change in the name of the medical monitor. This protocol change would require IRB review and approval prior to initiation of the change unless it was necessary to eliminate apparent immediate hazards to the subjects.

Date Published: 2013-02-08

What is the IRB required to do when there is a replacement of a study team member identified by title in the protocol and/or informed consent form?

If a study team member is replaced by another individual AND the IRB approved protocol and/or informed consent form identify the person by title and not name, a replacement by another individual with the same title is not a protocol or informed consent change. Therefore, no IRB review and approval is required. For example, if a Principal Investigator (PI) appointed a new research study coordinator to replace the original research study coordinator in an IRB-approved protocol when neither is mentioned by name, the replacement in personnel does not require review and approval by the IRB because the protocol remains unchanged.

Date Published: 2013-02-08

What is the IRB required to do when there are changes in key research staff named on IRB application forms?

IRB application forms are typically designed to assist an IRB in the review of a protocol. IRB application forms usually require the PI to include the names of the study team members associated with the protocol, often referred to as "key research staff" or "key personnel”. Changes in the status of key research staff or key personnel listed on an IRB application form do not require IRB review and approval unless

a. They are one of the following:
Principal Investigator (PI),
Local Site Investigator (LSI),
Co-PI or Co-LSI, or
Investigator; or

b. The local IRB requires it of other staff or personnel.

Date Published: 2013-02-08

What is the IRB required to do when there are changes in Principal Investigator, co-Principal Investigator, Local Site Investigator, or Investigator?

Changes in the PI, LSI, Co-PI, Co-LSI, or investigator of an IRB-approved protocol should be reviewed and approved by the IRB to ensure that the new individual meets criteria described in 38 CFR 16.111.

Date Published: 2013-02-08

Are Public Health Service (PHS) regulations regarding investigator financial conflicts of interest (FCOI) that went into effect August 24, 2012, applicable to VA research?

NO. The PHS regulations are found at 42 CFR 50.601-607 (especially 42 CFR 50.604, “Responsibilities of Institutions regarding Investigator financial conflicts of interest”) and do not apply to VHA. Although the PHS regulations state they are applicable to “each institution that is applying for, or that receives, PHS research funding …,” (42 CFR 50.601), the definition of “institution” excludes Federal agencies (42 CFR 50.603).

Date Published: 2013-02-08

What requirements on financial conflict of interest (FCOI) are applicable to VA research?

As a Federal agency, VA’s policies on FCOI must be consistent with requirements for government employees of the Executive Branch published by the Office of Government Ethics (OGE) established by the Ethics in Government Act of 1978. OGE is the agency providing overall direction, oversight, and accountability of Executive Branch policies designed to prevent and resolve conflicts of interest. Because the FCOI requirements for Federal agencies and the private sector are different, the requirements in VHA’s policy on FCOI will differ from those of VA facilities’ academic affiliates and the Nonprofit Corporations (NPCs).

As the VHA policy on Financial Conflict of Interest in Research is developed there will be some minor changes to the directions and processes related to how the form is used and to whom it is submitted, but there should be no change to the questions themselves. Once the VHA Office of Research and Development (ORD) and VA Office of General Counsel (OGC) develop the final version of the form used to report financial disclosures and business relationships, the form will be resubmitted to OGE for approval. The OGE approved version then will be posted on the VHA Publications website.

Date Published: 2013-02-08

What financial conflict of interest (FCOI) form must be used by VA investigators for VA research?

Currently the FCOI disclosure form found on ORD’s Tech Transfer Program website (Research Financial Conflict of Interest Statement located at http://www.research.va.gov/programs/tech_transfer/model_agreements/default.cfm) is the only FCOI disclosure form VA investigators can use for VA research. Local VA facilities create, redraft, or change this FCOI form. This version of the form may not be converted into a “PDF fillable” form.