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340 records found for: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.
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: R&DC,RDC, research and development committee, R&D Committee, RD Committee, designated reviews, DRs, expanded access protocols, EAPs, emergency use, FDA |
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.
FAQ # 11: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security Reviews, The Enterprise data security plan, ERDSP, ISSOs, Information System Security Officers |
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.
FAQ # 12: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security Reviews, ISSOs, Information System Security Officers , Information System Security Officer Reviews, ISSO reviews, ERDSP, The Enterprise Research Data Security Plan |
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:
FAQ # 21: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, Research and Development Committee, RDC, R&D Committee convened meeting, designated reviews, DRs, exempt research, exempt protocols, expedited reviews, emergency expanded access protocols |
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.
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/exempt-research.pdf Keywords: Exempt research, exempt reviews, exempt determinations, R&DC, RDC, R&D Committee, Research and Development Committee, continuing reviews |
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.
FAQ # 6: Source Document - NA Keywords: DocuSign, electronic signature, privacy, privacy officers, electronic informed consent forms, electronic consents, informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures, 21 CFR 11, Part 11 compliance, Part 11 compliant, 21 CFR part 11 |
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. FAQ # : Source Document - NA Keywords: VHA Directive 1200.08, biosafety, SRS, SRSS, Subcommittee on Research Safety and Security |
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. FAQ # 2: Source Document - NA Keywords: DocuSign envelopes, informed consent forms, electronic consent, electronic informed consent forms, informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures |
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).
FAQ # 3: Source Document - NA Keywords: DocuSign envelopes, informed consent, electronic informed consent, electronic consent, electronic informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures, HIPAA Authorizations |
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 FAQ # 4: Source Document - NA Keywords: DocuSign envelopes, informed consent, electronic informed consent forms, electronic consents, informed consent documents, written consents, writen informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures |
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.
FAQ # 5: Source Document - NA Keywords: DocuSign, electronic signature, privacy, privacy officers, electronic informed consent forms, electronic consents, informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures |
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.
FAQ # 1: Source Document - NA Keywords: DocuSign envelopes, informed consent, electronic consents, econsent, e-consent, electronic informed consent forms, informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, ICFs, remote consenting, remote informed consent, e-consent, econsent, digital signatures |
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:
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, non-Veterans, non Veterans |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, non-Veterans, non Veterans |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, non-Veterans, non Veterans |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, non-Veterans, non Veterans |
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). FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, employees, contractors, non-Veterans, non Veterans |
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 FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, non-Veterans, non Veterans, VHA medical record, health record, CPRS, VISTA, cerner, CPRS, electronic medical health record, electronic health record, EHR |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, flu shot |
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. FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, PPE, Personnel Protective Equipment, social distancing, social distance |
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. FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees, leave, benefits |
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 FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees |
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 FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, employees, VA employees, research subject injury, injured |
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. FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/Employee-Participation-COVID19-Research.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, VA employees |
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. FAQ # 13: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, FCOIs, FCOI Forms, OGE Form 450 Alternative VA, conflicts of interests, conflict of interest |
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. FAQ # 14: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, flow chart, flowchart |
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. FAQ # 15: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, resources, ask the mentor, training |
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. FAQ # 2: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, ORPP&E core library, forms, templates, wizards |
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). FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered countermeasure |
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)). FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, covered COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered countermeasure |
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. ” FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered countermeasure, covered persons |
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) FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, covered countermeasure, covered persons, liability protections |
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). FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, covered countermeasure |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, research-related injury, covered countermeasure, medical treatment |
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 FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, covered countermeasure |
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). FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, covered countermeasure, covered persons |
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. FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered countermeasure, informed consent forms, informed consent language, informed consent documents |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered persons, informed consent forms, informed consent language, informed consent documents, key information |
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:
FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, subject injury, subject injuries, covered persons, informed consent forms, informed consent language |
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. FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, covered COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered persons, informed consent forms, informed consent documents, informed consent language |
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. FAQ # 13: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, covered persons, informed consent forms, informed consent language, commercial IRBs, WIRB, Advarra |
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. FAQ # 14: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, Cooperative Research and Development Agreements, CRADAs |
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. FAQ # 15: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, covered COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, Cooperative Research and Development Agreements, non-CRADAs |
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. FAQ # 16: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, covered COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, Cooperative Research and Development Agreements, CRADAs, grant agreements |
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. FAQ # 17: Source Document - https://www.research.va.gov/resources/policies/guidance/Implementation-PREP-Act-COVID19.pdf Keywords: PREP act, public readiness and emergency preparedness act, covered COVID-19 countermeasure, COVID 19 countermeasure, coronavirus, SARS-CoV-2 virus, enrolling non-Veterans, recruiting non-Veterans, R&D Committee, RDC, Research and Development Committee |
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.
FAQ # 47: Source Document - https://www.research.va.gov/resources/policies/guidance/Mayo-Clinic-Convalescent-Plasma-Expanded-Access.pdf Keywords: iMed consent, iMed informed consent forms, electronic informed consent documents, documentation of informed consent, written consents, written informed consents, electronic consent, econsent, e-consent |
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.
FAQ # 6: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: VA Form 10-250, VAF 10-250, Privacy Review Checklists |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, critical interactions |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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.
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, project modifications opportunity, PMO, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, laboratory research, biospecimens |
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. FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
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. FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, personal cell phone, personal telephone calls |
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:
FAQ # 13: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
Date Published: 2020-06-22 How do I contact my ORD research service? For Biomedical Laboratory (BLRD): VHABLRD-CSRD@va.gov FAQ # 14: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, administrative hold, ORD research service |
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. FAQ # 15: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, IRB, Institutional Review Board |
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. FAQ # 16: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, IRB, Institutional Review Board |
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 FAQ # 17: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, screening study participants, screening research subjects |
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). FAQ # 18: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold |
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. FAQ # 19: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus |
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 FAQ # 20: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: Information Security platforms, software, Westat, Qualtrics, research surveys, survey research, remote data collection, research questionnaires |
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. FAQ # 21: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, study enrollment, critical interaction, ORD-Funded research, ORD funded research, ORD-sponsored research, ORD sponsored research |
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). FAQ # 22: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, research interviews, research observations |
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.
FAQ # 23: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, clinicaltrials.gov |
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). FAQ # 24: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, ORD service, ORD funded projects, ORD-funded research, ORD funded research, ORD-sponsored research, ORD sponsored research |
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.
FAQ # 25: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: email messages, e-mail messages, electronic mail, study recruitment, subject recruitment, subject recruiting subjects, text messages, research study communications |
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. FAQ # 26: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, funded research, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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). FAQ # 27: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: virtual research appointments, communicating with research subjects, research communications, video communication technology, PMO, Project Modification |
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. FAQ # 28: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, ORD services, award application and submission, funding awards, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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). FAQ # 29: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, award application and submission, funding awards, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 30: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, administrative hold, award application and submission, funding awards, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 31: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, IPA appointments |
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). FAQ # 32: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, awards, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 33: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, PM, portfolio manager, awards, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 34: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, study budget extensions, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 35: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, Career development awards, CDA, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 36: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, funding, financial and research progress performance reports, RPPR, grants management, portfolio manager, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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/. FAQ # 37: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, 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. FAQ # 38: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, Subcommittee on Research Safety and Institutional Animal Care and Use Committee, SRS, SRSS, IACUC, administrative hold |
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. FAQ # 39: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, ACC, FCP, research expenses, finance, budget, CFOs |
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. FAQ # 40: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, research expenses, finance, budget, incremental costs, research appropriation |
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. FAQ # 41: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, research expenses, finance, budget, research appropriation |
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. FAQ # 42: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, research expenses, finance, budget, personal protective equipment, PPE, supplemental funding |
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. FAQ # 43: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: Communications, COVID-19, COVID 19, coronavirus, publications, pubtracker, journal articles |
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. FAQ # 44: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, publications, journal articles |
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. FAQ # 45: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, publications, pubtracker, publication notification process, journal articles |
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. FAQ # 46: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, publications, pubtracker, resarch articles, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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 FAQ # 47: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus |
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.
FAQ # 48: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, Coronavirous, protected research time, merit awards, merit awardees, CADEs, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 49: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, JIT, funding awards, just-in-time, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 50: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, biospecimen collection, collection of biospecimens |
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. FAQ # 51: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, collections of biospecimens, biospecimen collections, future research, future studies |
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. FAQ # 52: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, collections of biospecimens, biospecimen collections |
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) FAQ # 53: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, future research, biorepository, biospecimen banking |
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. FAQ # 54: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, research funding, collection of biospecimens, biospecimen collections, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 55: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, biospecimens, collection of biospecimens, biospecimen collections, biorepository, biospecimen banking |
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.
FAQ # 57: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-19-FAQs.pdf Keywords: COVID-19, COVID 19, coronavirus, guidance, FAQs, clinical screening procedures |
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. FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal facility, animal research, animal studies, AAALAC site visits, AAALAC site inspections, AAALAC inspections, AAALAC inspection, program description, accreditation |
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). FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal facility budgets, animal studies |
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:
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, Webex, external monitors, electronic health record, EHR, CPRS, VISTA, Joint Legacy Viewer, JLV, |
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:
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors, HIPAA authorizations, |
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:
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors |
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:
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors, CPRS, VISTA, Joint Legacy Viewer, JLV |
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:
FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/Clinical-Trials-Webex.pdf Keywords: Clinical Trials, clinical trial monitors, remote monitoring visits, external monitors |
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. FAQ # 7: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Privacy, Informed consent forms, informed consent documents, tissue banking, biospecimen banking, data banking, repository, Combined informed consent form and HIPAA authorizations, combined ICF/HIPAA, combined ICF HIPAA, HIPAA Authorization Forms, documentation of informed consent, written informed consents |
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. FAQ # 8: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Privacy, HIPAA Authorization Forms, HIPAA Authorizations, VA Form 10-0493, data banking, biospecimen banking, tissue banking, data repository, biospecimen repository, optional banking |
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. FAQ # 9: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Privacy Boards, waiver of HIPAA Authorization Forms, written HIPAA authorization Forms, HIPAA Authorizations, HIPAA waivers, personal representatives, IRB, Institutional Review Board |
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. FAQ # 10: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Privacy Board, waiver of HIPAA authorization, HIPAA waivers, PHI, protected health information, data disclosures, disclosing data |
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.
FAQ # 2: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Remdesivir, Emergency Use Authorization EUA, COVID-19, covid 19, coronavirus |
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:
FAQ # 3: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: VAIRRS, IRB Net, IRBNet, rollout schedule |
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. FAQ # 4: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: VA Central IRB, VA CIRB, VA Central Institutional Review Board, COVID-19 research study , COVID 19 research study, coronavirus |
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.
FAQ # 5: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Exempt Research, Exempt Reviews, RCO audits, research compliance officer |
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. FAQ # 13: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security, ISSOs, Information System Security Officers, central ISSO reviews, multisite research, collaborative research |
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. FAQ # 14: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: information security reviews, ISSO reviews, ISSOs, Information System Security Officers, RSD, Research Support Division |
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.
FAQ # 15: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security platforms, VA RedCap, VA red cap |
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. FAQ # 16: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security platforms, VA Redcap, va red cap, PHI, protected health information, PII, personally identifiable information |
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. FAQ # 17: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security, informed consent forms, informed consent documents, HIPAA authorization forms, PHI/PII, PHI PII, protected health information, scanning, scanner |
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:
FAQ # 18: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security, transferring data outside VA, data transfer, transferring data externally, research data disclosures, disclosing research data, disclosing data |
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:
FAQ # 19: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/Spring-Research-TownHall-FAQs.pdf Keywords: Information Security, Information System Security Officers, ISSOs, Collaborative Institutional Training Initiative, CITI training |
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. FAQ # 22: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, Research and Development Committee, RDC, R&D Committee designated reviews, DR |
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. FAQ # 23: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, Research and Development Committee, RDC, R&D Committee designated reviews, DR |
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. FAQ # 24: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, Research and Development Committee, RDC, R&D Committee amendments, modifications, changes to investigators, investigator changes |
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. FAQ # 14: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, Research and Development Committee, RDC, R&DC, subcommittees, external committees |
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.)). FAQ # 15: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: Research and Development Committee approvals, R&DC, RDC, R&D Committee, continuing reviews, annual reviews, amendments, reportable events |
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. FAQ # 16: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: ACOS/R&D notification, ACOS/R, ACOS Research, study initiation, R&DC, RDC, R&D Committee, Research and Development Committee |
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. FAQ # 17: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: ACOS/R&D notification, ACOS/R, ACOS Research, continuing reviews, annual reviews, amendments |
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). FAQ # 18: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: ACOS/R&D notification, ACOS/R, ACOS Research |
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.
FAQ # 19: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, Research and Development Committee, RDC, R&DC, subcommittee or committee |
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. FAQ # 20: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, Research and Development Commmittee, RDC, R&DC, research records, study records, protocol file, external 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.
FAQ # 25: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, Research and Development Committee, RDC, R&D Committee amendments, modifications, changes to study team members, study team member changes |
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.
FAQ # 26: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, RDC, R&DC, Research and Development Committee lapse in approval, R&DC approval lapses |
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. FAQ # 29: Source Document - https://www.research.va.gov/resources/policies/guidance/Mayo-Clinic-Convalescent-Plasma-Expanded-Access.pdf Keywords: convalescent plasma for COVID-19, CCP, COVID 19, donating plasma donations, donate plasma |
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. FAQ # 30: Source Document - https://www.research.va.gov/resources/policies/guidance/Mayo-Clinic-Convalescent-Plasma-Expanded-Access.pdf Keywords: convalescent plasma for COVID-19, CCP, COVID 19, employees, donating plasma donations, donate plasma |
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 FAQ # 32: Source Document - https://www.research.va.gov/resources/policies/guidance/Mayo-Clinic-Convalescent-Plasma-Expanded-Access.pdf Keywords: convalescent plasma for COVID-19, CCP, COVID 19, donating plasma donations, donate plasma |
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.
FAQ # 38: Source Document - https://www.research.va.gov/resources/policies/guidance/Mayo-Clinic-Convalescent-Plasma-Expanded-Access.pdf Keywords: convalescent plasma for COVID-19, CCP, COVID 19, donating plasma donations, donate plasma |
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):
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animals, transmission, animal to human transmission, human to animal transmission |
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. FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVISD 19, coronavirus, animal facility, animal research, animal studies, personal protective equipment, PPE |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal facility, animal research, animal studies, AAALAC site visits, AAALAC inspection, AAALAC site inspection, accreditation |
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. FAQ # 16: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, waivers of animal research |
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. FAQ # 17: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, IACUC meetings, Institutional animal care and use committee, animal research SOPs, Standard operating procedures |
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. FAQ # 18: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: animal research, animal studies, PHS assurance, OLAW, waiver from OLAW |
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. FAQ # 19: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, Site visits, site inspections, Institutional Animal Care and Use Committee, audits |
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. FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal facility, animal research, animal studies, AAALAC site visits, AAALAC inspections, AAALAC site inspections, accreditation |
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:
FAQ # 13: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal facility, animal research, animal studies, semiannual facility inspections, site visits, site inspections |
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:
FAQ # 14: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, OLAW, IACUC meetings, Institutional animal care and use committee |
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).
FAQ # 15: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, IACUC meetings, Institutional animal care and use committee, waivers of animal research, waiver of animal research |
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.”
FAQ # 20: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal research, animal studies, containment practices, biosafety level-3, bsl-3, BSL 3, BSL3 |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, administrative hold, animal research, animal studies |
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.
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal care, animal research, animal studies |
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).
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal care, animal research, animal facility, animal studies |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal care, animal research, animal studies |
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.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal care, funded animal research, funded animal studies |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/animal-care-FAQ-COV-19.docx Keywords: COVID-19, COVID 19, coronavirus, animal care, animal research, animal studies, ORD funded research, ORD sponsored research, ORD-funded research, ORD-sponsored research |
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. FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: Privacy, HIPAA waivers, waiver of HIPAA authorization forms, alteration of HIPAA authorization forms, COVID-19, Covid 19, coronavirus, protected health information, PHI |
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:
FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: COVID-19, covid 19, study initiation, critical interactions, ACOS/R&D, ACOS/RD, ACOS research |
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 FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: amendments, modifications, Covid, Covid-19, covid 19 |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: amendments, modifications, Covid, Covid-19, covid 19 |
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 FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: suspensions, suspending, Covid, Covid-19, covid 19 |
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.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: informed consent forms, informed consent documents, reconsenting, amendments, modifications, written consents, written informed consents, documentation of informed consent |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: informed consent forms, informed consent documents, written consents, written informed consents, signed consents, documentation of consent, documentation of informed consent, amendments, modifications |
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
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: Covid 19, COVID-19, coronavirus, documentation of informed consent, written informed consents, written consents, informed consent forms, informed consent documents, written consents, signed consents |
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.
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/FAQs-HumanSubjectProtection-COVID19.pdf Keywords: privacy, written signed HIPAA authorization forms, COVID-19, covid 19, coronavirus, PHI, protected health information |
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 FAQ # 28: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: biosafety, PPE, personal protective equipment |
Date Published: 2020-04-04 What is the difference between BSL-1, 2 and 3 laboratories? Document image included in Original FAQ FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: Biosafety, BSL-1, BSL-2, BSL-3, BSL 1, BSL 2, BSL 3, BSL1, BSL2, BSL3, COVID-19, COVID 19 |
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 FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, laboratory risk assessments |
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 FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, persons under investigation PUI, personal protective equipment, PPE |
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). FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, persons under investigation PUI, personal protective equipment, PPE |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, personal protective equipment, PPE, nasopharyngeal swab, N-95, N95, persons under investigation PUI |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, aerosol generating procedures AGP |
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.
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, aerosol generating procedures AGP |
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. FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, Airborne Infection Isolation Room AIIR |
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 FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, disinfectants, EPA |
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.
FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, research specimens, BSL-2, BSL2, BSL 2 |
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. FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, biospecimen storage, research specimens, storing specimens |
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. FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, laboratory biohazardous waste, decontamination |
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. FAQ # 13: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimen transport and handling, shipping |
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. FAQ # 14: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety standard precautions |
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. FAQ # 15: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, aerosols and droplets |
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. FAQ # 16: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, infectious aerosols and droplets |
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.
FAQ # 17: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, cultures, isolates, transportation, training, shipping |
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)
FAQ # 18: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens cultures isolates, transportation, transporting, packaging, shipping |
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 FAQ # 19: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: Covid-19, COVID 19, coronavirus, category B infectious substances, category B substance |
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. FAQ # 20: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, transportation, transporting, shipping, temperature |
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 FAQ # 21: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, transporting, transportation, shipping |
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. FAQ # 22: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus isolation work, biosafety level 3, biospecimens, BSL-3, BSL3, BSL 3 |
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. FAQ # 23: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens transporting transportation shipping driving walking |
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:
FAQ # 24: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, biospecimens, biological spill, biological exposure |
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. FAQ # 25: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: COVID-19, COVID 19, coronavirus, biosafety, unprotected exposure, biospecimen |
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.
FAQ # 26: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: biosafety, PPE, personal protective equipment surgical mask N95 respirator |
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:
FAQ # 27: Source Document - https://www.research.va.gov/resources/policies/guidance/COVID-Biosafety-Specimen-Guidance.pdf Keywords: biosafety, PPE, personal protective equipment N95 respirator |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Informed-Consent-Forms-revisions.pdf Keywords: protocol modifications revisions, informed consent documents, informed consent form modifications, informed consent form revisions, ICF modifications, ICF revisions , ICF amendments, informed consent form changes, changes to informed consent forms |
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) FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Informed-Consent-Forms-revisions.pdf Keywords: informed consent forms, informed consent documents, ICF modifications, ICF revisions, ICF amendments, mutli-site research, collaborative research, multisite research |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Informed-Consent-Forms-Expiration.pdf Keywords: informed consent forms, informed consent documents, study expiration dates, ICF expiration dates |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/IRB-Membership-admin.pdf Keywords: IRB membership, Institutional Review Boards, IRB voting members, alternate voting members |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/IRB-Membership-admin.pdf Keywords: IRB membership, Institutional Review Board, affiliate IRB membership, IRB voting members, alternate voting members |
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.
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/ImplementingScreening-COVID19.pdf Keywords: COVID-19, COVID 19, coronavirus, SARS-CoV-2 virus, clinical screening procedures, safety changes |
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. FAQ # 1: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNET, ORPP&E core library, forms, templates, wizards |
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. FAQ # 3: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, ePromise, e promise, e-promise |
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. FAQ # 4: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, training energizers |
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. FAQ # 5: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, ORPP&E core library, forms, templates, wizards, 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. FAQ # 6: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, smart forms |
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. FAQ # 7: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, skype for business |
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. FAQ # 8: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, TMS, CITI training |
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. FAQ # 9: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, OGE Form 450 Alternative VA, Conflicts of Interests, Conflict of Interests, FCOIs, financial conflict of interests, FCOI Forms |
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. FAQ # 10: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, FASR, Feasibility Alignment and Scientific Review, forms, checklists |
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. FAQ # 11: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, FASR, Feasibility Alignment and Scientific Review |
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. FAQ # 12: Source Document - https://www.research.va.gov/programs/orppe/vairrs/faq.cfm Keywords: VAIRRS, IRB Net, IRBNet, FASR Reviewer checklists, Feasibility Alignment and Scientific Review, forms, checklists |
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 FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS, informed consent forms, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication, information security platform |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS, informed consent forms, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication, information security platform, data transfer |
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). FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services,Azure RMS, informed consent, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication, information security platform, PHI, protected health information, PII |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS, informed consent forms, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication, information security platform, secure email, secure e-mail |
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:
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS, informed consent , remote consent, remote informed consent, subject recruitment, communicating with subjects, subject communication, information security platform, PHI, protected health information, PII, email |
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).
FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS protected message, informed consent forms, remote consent, remote informed consent, secure communication, communicating with subjects, subject communication, information security platform, secure email |
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:
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/FAQs-Azure-RMS.pdf Keywords: Azure Rights Management Services, Azure RMS, informed consent forms, remote consent, remote informed consent, documentation of informed consent, secure communication, communicating with subjects, subject communication, information security platform |
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.
FAQ # 1: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHADirective1200-05-Certificates-of-Confidentiality.docx Keywords: COCs, certificates of confidentiality, certificate of confidentiality |
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. FAQ # 2: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHADirective1200-05-Certificates-of-Confidentiality.docx Keywords: COCs, certificates of confidentiality, certificate of confidentiality, informed consent forms, informed consent documents, medical record, cerner, CPRS, electronic medical health record, electronic health record, EHR |
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.
FAQ # 12: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&DC, RDC, R&D Committee, Research and Development Committee Subcommittee Meeting minutes, subcommittee minutes |
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. FAQ # 13: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: recuitment of non-Veterans, non-Veteran recruitment, non Veteran recruitment, inclusion of non-Veterans, enrolling non-Veterans, recruiting non-Veterans, non-Veteran recruiting, ORD-funded study, ORD-funded research, ORD funded research, ORD funded study |
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. FAQ # 1: Source Document - https://www.va.gov/ORO/Docs/RCO/ORO_Interpretation_VHA_Handbook_1058_01.pdf Keywords: Reportable events, exempt research, exempt reviews, reportable events, non-compliance, non compliance, adverse events, ORO, VHA Handbook 1058.01, VHA Directive 1058.01 |
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:
FAQ # 2: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: Research and Development Committees, R&D Committee subcommittees, RDC, R&DC subcommittees, external committees, quality assurance and quality improvement activities, QA/QI, QAQI |
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.
FAQ # 3: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: recruitment of non-Veterans, recruiting non-Veterans, non-Veteran recruiting, inclusion of non-Veterans, non-Veteran recruitment, enrolling non-Veterans, non-Veteran enrollment, enrollment of non-Veterans, non Veterans, research subject injury, medical treatment, research-related injury, research related injury, |
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). FAQ # 7: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: VA Central IRB, VA CIRB, VACIRB, VA Central Institutional Review Board, external committees, R&D Committee subcommittee of the R&D Committee |
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:
FAQ # 11: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: Collaborative Institutional Training Initiative, CITI training, Research and Development Committee training, R&DC, RDC, R&D Committee |
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:
FAQ # 5: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee Subcommittees, R&DC Subcommittee, RDC Subcommittee, Research and Development Committee Subcommittees, Subcommittee Standard Operating Policies and Procedures, SOPs |
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)?
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. FAQ # 6: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: quality assurance reviews, quality improvement reviews, QA/QI, QAQI, ACOS/R&D, ACOS Research aand Development, ACOS/Research, Associate Chief of Staff |
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. FAQ # 8: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: VA Central IRB, VA CIRB, VACIRB, VA Central Institutional Review Board, internal IRB, external 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. FAQ # 9: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: single patient expanded access protocols, R&D Committee, RDC, R&DC, Research and Development Committee |
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. FAQ # 10: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, R&DC, RDC, Research and Development Committee continuing reviews, expedited reviews, expedited research, annual reviews, 2018 Rule, 2018 Requirements, Revised Common Rule, transitioning research, transitioned studies, transitioned research |
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. FAQ # 4: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: recruitment of non-Veterans, non-Veteran recruitment, recruiting non-Veterans, non-Veteran recruiting, inclusion of non-Veterans, enrolling non-Veterans, non-Veteran enrollment, enrollment of non-Veterans, non Veterans, designated reviews,designated review process,DR,R&DC,R&D Committee,Research and Development Committee,RDC, Enrollment of new test test test test |
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.?
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)).
FAQ # 1: Source Document - https://www.research.va.gov/programs/orppe/policy/faq/VHA-Directive-1200-01-faq.pdf Keywords: R&D Committee, RDC, R&DC, Research and Development Committee, subcommittees, subcommittee minutes approval, approve subcommittee minutes, meeting minutes |
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:
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, IRBs |
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.
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, IRBs |
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.
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, IRBs |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, IRBs |
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.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, IRBs |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, IRBs |
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.
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule |
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.
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule |
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.
FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, informed consent |
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.
FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule, exempt research |
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:
FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/transitioning-human-subj-research.pdf Keywords: Revised Common Rule, revised final rule, 2018 Rule, 2018 Requirements, pre-2018 Rule, pre-2018 Requirements, transitioning research, transitioning studies, transitioned study, transitioned research, pre-2018 requirements, pre-2018 rule |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, revised final rule |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, revised final rule, cooperative research provision, single IRB review, single IRB requirement |
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:
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, grants, definition of research, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, grants, definition of research, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, three burden-reducing provisions, three burden reducing provisions, revised final rule, documentation, documenting transition |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, continuing reviews, annual reviews, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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:
FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, three burden-reducing provisions, three burden reducing provisions, revised final rule, documentation, documenting transition |
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. FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, definition of research, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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.
FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, grants, contract proposals, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, grants, grant application, proposal, R&DC, RDC, Research and Development Committee, three burden-reducing provisions, three burden reducing provisions, revised final rule, documenting transition |
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.
FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/Final-Rule_and_Burden-Reducing-Provisions.pdf Keywords: Revised Common Rule, 2018 Requirements, 2018 Rule, three burden-reducing provisions, three burden reducing provisions, revised final rule |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet, communicating with subjects, communication with subjects, subject communication, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet, communicating with subjects, subject recruitment, subject communication, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication |
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)).
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet, communicating with subjects, communication with subjects, subject communication, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication, IRB |
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:
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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.
FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication, IRB |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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.
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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.
FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication, study complaints, IRB |
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. FAQ # 11: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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.
FAQ # 12: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication, COCs, certificate of confidentiality, |
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. FAQ # 13: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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.
FAQ # 14: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: Myhealthevet secure messaging, my healthevet secure messaging, communicating with subjects, communication with subjects, subject communication, secure communication, securely communicating with subjects, subject communication |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/MyHealtheVet-SecureMessaging.pdf Keywords: my healthevet, Myhealthevet secure messaging, communicating with subjects, communication with subjects, subject communication, remote consent, remote informed consent, secure communication, securely communicating with subjects, subject communication |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
Date Published: 2017-07-28 What should be in a MTA? At a minimum, the following should be included in a MTA:
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens, Data use agreements, DUAs |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens |
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. FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, biospecimens, templates |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-mta-guidance.pdf Keywords: Material transfer agreements, MTAs, 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.
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, e-mails, electronic mail, subject recruiting subjects, subject recruitment, Advertisements, recruiting, recruitment, ads, advertising, communicating with subjects, communication with subjects, subject communication |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Text messaging, texts, subject recruiting subjects, subject recruitment, Advertisements, recruiting, recruitment, ads, advertising, communicating with subjects, communication with subjects, subject communication |
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)
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, e-mails, text messaging, texts, recruiting, Advertisements, recruiting, subject recruitment, ads, advertising, communicating with subjects, communication with subjects, subject communication, PII, Personally identifiable information |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, text messaging, texts, e-mails, recruiting, recruiting, subject recruitment, communicating with subjects, communication with subjects, subject communication, PHI, protected health information |
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 #.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, text messaging, texts, e-mails, recruiting, recruiting, subject recruitment, communicating with subjects, communication with subjects, subject communication, PII, Personally identifiable information, PHI, protected health information |
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.
FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, text messaging, texts, e-mails, electronic mail, communicating with subjects, communication with subjects, subject communication, study reminder |
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:
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, text messaging, texts, e-mails, electronic mail, subject recruiting subjects, subject recruitment, Advertisements, recruiting, ads, advertising, communicating with subjects, communication with subjects, subject communication |
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.
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, e-mails, electronic mail, subject recruiting subjects, subject recruitment, Advertisements, ads, advertising, communicating with subjects, communication with subjects, subject communication, PII, Personally identifiable information, VA employees, |
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.
FAQ # 9: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: Emails, e-mails, texts, text messaging, electronic mail, recruiting, subject recruitment, Advertisements, recruiting, ads, advertising, communicating with subjects, communication with subjects, subject communication |
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. FAQ # 10: Source Document - https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf Keywords: emails, e-mails, email messages, Myhealthevet secure messaging, my healthevet secure messaging, recruting, subject recruitment, communicating with subjects, communication with subjects, subject communication, subject recruiting 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.
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/HIPAA-Revocation-FAQ.pdf Keywords: Privacy, HIPAA revocation, revoke HIPAA authorization forms, revocation of authorization, revocation of HIPAA authorization, VA Form 10-10116, VAF 10-10116, PHI, protected health information, data disclosures, disclosing data |
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.” FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, affiliations |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, academic affiliate, academic affiliations, |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, academic affiliate, academic affiliations, |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, affiliations |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, affiliations |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated members, non affiliated members, IRB membership rosters, IRB rosters, affiliations |
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.
FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated member, non affiliated members, IRB membership rosters, IRB rosters, WOC appointments, without compensation appointments, affiliations |
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.
FAQ # 8: Source Document - https://www.research.va.gov/resources/policies/guidance/NonAffiliated-IRB.docx Keywords: IRB membership, non-affiliated member, non affiliated members, IRB membership rosters, IRB rosters, WOCs, Without compensation appointments, affiliations |
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.
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy information, Pregnant women, vulnerable populations, fetus, |
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.
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy information, Pregnant women, vulnerable populations, fetus, |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy information, Pregnant women, vulnerable populations, neonate, newborn infants, children, child, minor |
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:
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy outcomes, Pregnant women, vulnerable populations, fetus, neonate, newborn, infants, children, child, IRB review, Institutional Review Board review, |
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.
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy information, Pregnant women, vulnerable populations, neonate, newborn infants, children, Facility Director certification, facility Director approval, facility directors certification, facility directors approval |
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.
FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/pregnancy.pdf Keywords: Pregnancy information, Pregnant women, vulnerable populations, fetus, Facility Director certification, facility Director approval, facility directors certification, facility directors approval |
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:
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/recruitment-non-va.pdf Keywords: Advertisements, recruiting documents, subject recruitment documents, ads, advertising, flyers, non-VA research, non VA research, subject recruiting subjects |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/recruitment-non-va.pdf Keywords: Advertisements, recruiting documents, subject recruitment documents, subject recruiting subjects, ads, advertising, flyers, non-VA research, non VA research, Facebook page, social media |
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:
FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/ContinuingReview.pdf Keywords: Continuing reviews, IRB, Institutional Review Boards, annual reviews, |
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:
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/ContinuingReview.pdf Keywords: Continuing reviews, IRB, Institutional Review Boards, annual reviews |
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:
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/ContinuingReview.pdf Keywords: Continuing reviews, IRB, Institutional Review Boards, annual reviews |
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.
FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/ContinuingReview.pdf Keywords: Continuing reviews, IRB, Institutional Review Boards, annual reviews, expedited review procedures, expedited procedure |
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:
FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/ContinuingReview.pdf Keywords: Continuing reviews, IRB, Institutional Review Boards, annual reviews, lapse of IRB approval, lapse of approval, approval lapses |
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 FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf Keywords: Children, infants, vulnerable populations, Facility Director certification, facility Director approval |
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:
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf Keywords: Children, infants, vulnerable populations, Facility Director certification, facility Director approval |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf Keywords: Children, infants, vulnerable populations, IRB review, Institutional Review Board review |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf Keywords: Research involving Children, infants, vulnerable populations, RDC review, Research and Development Committee review, R&D Committee review, R&DC review |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/research-involving-children.pdf Keywords: research involving Children, infants, vulnerable populations, Facility Director certification, facility Director approval, facility director approval memo, facility director memo of approval |
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 FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, International FWA, International Federal Wide Assurance |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, international sites |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, IRB, Institutional Review Board reviews, IRB reviews, international sites |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, International sites, IRB reviews, Institutional Review Board |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, International sites, R&DC, R&D Committee, Research and Development Committee |
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. FAQ # 6: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, Facility Director certification, Facility Director approval, Medical Center Director certification, Medical Center Director approval |
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. FAQ # 7: Source Document - https://www.research.va.gov/resources/policies/guidance/intl-research.pdf Keywords: International research, International sites, Cooperative Studies Program, CSP |
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 FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf Keywords: Pregnancy, Pregnant women, vulnerable populations, fetus, Facility Director certification, facility Director approval, facility directors certification, facility directors approval, Medical Center Director certification, Medical Center Director approval |
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 FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf Keywords: Pregnancy, Pregnant women, vulnerable populations, fetus |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf Keywords: Pregnancy, Pregnant women, vulnerable populations, fetus, IRB review, Institutional Review Board review |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf Keywords: Pregnancy, Pregnant women, vulnerable populations, fetus, R&D Committee, RDC, Research and Development Committee |
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. FAQ # 5: Source Document - https://www.research.va.gov/resources/policies/guidance/ResearchInvolving-PregnantWomen.pdf Keywords: Pregnancy, Pregnant women, vulnerable populations, fetus, Facility Director certification, facility Director approval, facility directors certification, facility directors approval, Medical Center Director certification, Medical Center Director approval |
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. FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Changes-Team-Members.pdf Keywords: IRB reviews, Institutional Review Board Reviews, Amendments, Modifications, Study Team Changes, Changes to study team members |
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. FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Changes-Team-Members.pdf Keywords: IRB reviews, Institutional Review Board Reviews, Amendments, Modifications, Study Team Changes, Changes to study team members |
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
FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Changes-Team-Members.pdf Keywords: IRB reviews, Institutional Review Board Reviews, Amendments, Modifications, Study Team Changes, Changes to study team members |
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. FAQ # 4: Source Document - https://www.research.va.gov/resources/policies/guidance/Changes-Team-Members.pdf Keywords: IRB reviews, Institutional Review Board Reviews, Amendments, Modifications, changes to investigators, investigator changes |
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). FAQ # 1: Source Document - https://www.research.va.gov/resources/policies/guidance/Financial-Conflict-of-Interest.pdf Keywords: financial conflicts of interests, FCOIs, financial conflict of interest |
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).
FAQ # 2: Source Document - https://www.research.va.gov/resources/policies/guidance/Financial-Conflict-of-Interest.pdf Keywords: financial conflicts of interests, FCOIs, financial conflict of interest forms |
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. FAQ # 3: Source Document - https://www.research.va.gov/resources/policies/guidance/Financial-Conflict-of-Interest.pdf Keywords: financial conflicts of interests, FCOIs, financial conflict of interest forms, financial conflicts of interest statements, FCOI disclosure forms |