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Human Research

QUESTIONS? Contact VHA CO ORD Regulatory at VHACOORDRegulatory@va.gov

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    Release Date 
    Guidance Document 
    Topic 
    2023-07-19 ORD Guidance Document: Applicability of the Exclusion of VHA Research From the Paperwork Reduction Act Paperwork Reduction Act
    2023-07-19 Description of Amendment 3 to VHA Directive 1200.05 VHA Directive 1200.05 Amendment #3 Guidance
    2023-07-12 ORD Guidance: Instructions for Use of VA DocuSign for VA Facilities Conducting the CDC Expanded Access Program: “Use of Tecovirimat (TPOXX) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children” Tecovirimat CDC Expanded Access Program – Guidance on VA DocuSign
    2023-04-04 Form for Documentation of Non-Research Activities For Publications Outside the VA Non-Research Determinations
    2022-05-09 Frequently Asked Question: California State Law Applicability for Separation of HIPAA Authorization for Research and Informed Consent Document California State Law (CMIA) Applicability: HIPAA and ICD
    2022-03-01 2022 ORD IT FAQs and Guidance IT
    2021-07-26 Office of Research and Development (ORD) and Office of Nursing Services (ONS) Guidance: VA Facility Participation in the 2021 Press-Ganey Research Study: RN National Database of Nursing Quality Indicators RN Survey Human Subjects Research
    2021-06-29 Acting USH Memorandum on Recruitment of Veterans for Research Studies, June 29, 2021 (Proactive Calling for Recruitment) Proactive Calling for Recruitment
    2021-03-31 FAQs: R&D Committee R&D Committee
    2021-01-08 Description of Amendment 1 to VHA Directive 1200.01 VHA Directive 1200.01 Amendment #1 Guidance
    2021-01-08 Description of Amendment 2 to VHA Directive 1200.05 VHA Directive 1200.05 Amendment #2 Guidance
    2021-01-08 Description of Amendment 1 to VHA Directive 1200.08 VHA Directive 1200.08 Amendment #1 Guidance
    2020-10-15 Research Guidance for the Use of Electronic Methods to Securely Obtain Informed Consent (VA network access only) Informed Consent Forms
    2020-09-24 Veterans Health Administration (VHA) Office of Research and Development (ORD) Guidance on VA Employee Participation in VA-Conducted COVID-19 Research Studies Employee Participation in COVID-19 studies
    2020-08-17 Implementation of the Public Readiness and Emergency Preparedness Act(PREP Act) for COVID-19 Research Activities COVID-19 PREP Act
    2020-06-22 Frequently Asked Questions (FAQs) Regarding COVID-19 Impacts on Research COVID-19- FAQs
    2020-06-18 ORD Guidance on Remote Monitoring of VA Clinical Trials by External Monitors Using the Webex Collaboration Technology Sharing Platform Remote Monitoring
    2020-06-01 Please refer to VHA Handbook 1200.12; revised DUA Templates to be released Data Use Agreement
    2020-05-04 FAQs: Spring Research Town Hall Q&A (Updated: 2021-03-31) Human Subjects Research
    2020-05-01 Memorandum VA COVID-19 Research Biorepositories/Biobanks COVID-19
    2020-04-13 Frequently Asked Questions (FAQs) - COVID-19 and VA Animal Care and Use Programs COVID-19- FAQs
    2020-04-07 Memorandum: Use of Video Communication Technology for VHA Research and Development Activities Under COVID-19 COVID-19
    2020-04-06 Human Subject Protection Issues Related to COVID-19 Frequently Asked Questions (Updated: 2021-03-31) COVID-19 FAQS
    2020-04-04 COVID-19 (SARS-CoV-2) Research Specimens - Frequently Asked Questions COVID-19- FAQs
    2020-03-17 CRADO Memorandum for Administrative Hold on Non-Critical, In Person Interactions with Human Research Subjects in ORD-Funded Studies COVID-19
    2020-03-06 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 (Updated: 2020-03-10) COVID-19
    2020-01-22 Information about Requesting Use of IRBs and Exceptions to the Single IRB Requirement Single IRB Requests Single IRB Exceptions
    2019-10-25 IRB and R&D Committee Considerations for Use of Azure Rights Management Services (RMS) in VA Research Azure Rights Management Services
    2019-10-02 Notification Alert: Research Involving E-Cigarettes/ENDS E-Cigarettes/ENDS
    2019-09-01 Information about Use of the NCI IRB by VA Facilities National Cancer Institute IRB
    2019-08-07 Clarification of ORO's Requirements for the Review of Reportable Events in Exempt Human Subjects Research- VHA Handbook 1058.01 Exempt Research
    2019-08-02 ORD Guidance on Transitioning VA Human Research Studies to the Revised Federal Policy for the Protection of Human Subjects Transitioning to 2018 Requirements
    2019-01-09 Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05 VHA Directive 1200.05 General Guidance
    2018-07-28 DRAFT ORD Guidance on Material Transfer Agreements (Updated: 2021-03-31) Material Transfer Agreements
    2018-03-12 Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet Email Communications
    2017-07-28 DRAFT Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research Electronic Mail and Texting
    2017-02-21 FAQ on Revocation of HIPAA Authorization for Research HIPAA Authorization
    2015-04-16 ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members Non-Affiliated IRB Members
    2015-03-09 Guidance on Advertisement of Non-VA Funded Research in VA Facilities Advertising
    2015-03-09 Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring Pregnancy
    2014-10-20 Guidance on Conducting Research Involving Children Children
    2014-10-20 Guidance on Exempt Research Determination Exempt Research
    2014-10-20 Guidance on Approval of International Research International Research
    2014-10-20 Guidance on Conducting Research Involving Pregnant Women Pregnancy
    2014-09-05 Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART) SSN Data Requests in DART
    2013-08-02 FAQ on Financial Conflict of Interest Conflict of Interest
    2013-02-08 Guidance on IRB Approval of Changes in Study Team Members 2 Study Team Changes
    2012-03-12 FAQ on Administrative Staff Membership on the IRB IRB Membership
    2012-03-12 FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms Informed Consent Forms
    2012-03-12 Informed Consent Forms - Expiration Dates Informed Consent Forms
    2009-12-09 Case Report Guidance Case Reports
    -- See Off-site Research page Off-site Research
    -- ORD Guidance for Use of Facebook and Twitter when Recruiting Research Subjects in VA Research (Guidance Under Revision. Temporarily removed on 09/26/2017) Social Media

    Requesting Use of DocuSign for VA-approved Research

    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.

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

    Requests for the use of DocuSign are usually reviewed and decided within 2-3 business days if all appropriate information is provided.

    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 (VA network access only)

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

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