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Office of Research & Development

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Human Subjects Research Policies and Guidance

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Please use this form to ask questions, and search for guidance documents on this page, using the search bar below.

 

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Release Date 
Guidance Document 
Topic 
2024-10-17 ORD Frequently Asked Question (FAQ) on Required Signatures and Dates for Subjects or Subjects’ Legally Authorized Representatives (LARs) on the California’s Experimental Subject’s Bill of Rights California Law and Experimental Subject’s Bill of Rights
2024-07-23 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
2023-07-19 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
2023-04-04 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
2018-08-02 Program Guide 1200.16: Off-Site Research Off-site Research
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 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
-- 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
-- Partial Off-site Waiver Request Template Off-site Research
-- Biosafety Level 3 (BSL-3) MOU Template Off-site Research

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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