Office of Research & Development

Human Research

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Draft Guidance Documents

• Electronic Mail and Texting: Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research (July 28, 2017)
• Material Transfer Agreements: Draft ORD Guidance on Material Transfer Agreements (July 28, 2017)

Guidance Documents

• Advertising: Guidance on Advertisement of Non-VA Funded Research in VA Facilities(March 9, 2015)
• Burden Reducing Provisions and the Final Rule: ORD Guidance on the Final Rule for the Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date While Allowing the Use of Two Burden-Reducing Provisions During the Delay Period (July 2, 2018)
• Case Reports: Case Report Guidance (December 9, 2009)
• Children: Guidance on Conducting Research Involving Children (October 20, 2014)
• Confidentiality: ORD Guidance on Certificates of Confidentiality (April 23, 2015)
• Conflict of Interest: FAQ on Financial Conflict of Interest (February 8, 2013)
• Continuing Review: Guidance on Continuing Review (October 22, 2014)
• Data Use Agreement with Non-Federal Entities: Data Use Agreement with Non-Federal Entities for Data Sharing Between DVA, VHA, and Non-Federal Entity/Recipient(March 2016)
• Email Communications: Guidance for VA Researchers on the Use of Secure Messaging through My HealtheVet (March 12, 2018)
• Exempt Research: Guidance on Exempt Research Determination(October 20, 2014)
• HIPAA Authorization: FAQ on Revocation of HIPAA Authorization for Research (February 21, 2017)
• Informed Consent Forms: FAQ on Implementation of IRB-Approved Revisions to Protocols and Consent Forms(March 12, 2012)
• Informed Consent Forms: FAQ on Expiration Dates on Informed Consent Forms (March 12, 2012)
• International Research: Guidance on Approval of International Research (October 20, 2014)
• IRB Membership: FAQ on Administrative Staff Membership on the IRB(March 12, 2012)
• Non-Veterans in Research: FAQ on Recruitment of Non-Veterans for VA Research (March 12, 2012)
• Non-affiliated IRB Members: ORD Guidance on Non-affiliated Institutional Review Board (IRB) Members(April 16, 2015)
• Off-site Research (see Off-site Research page)
• Pregnancy: Guidance on Conducting Research Involving Pregnant Women (October 20, 2014)
• Pregnancy: Guidance on Collecting Data on Pregnancy and Outcomes of Pregnancy from VA Research Subjects and Pregnant Partners of VA Research Subjects for Safety Monitoring(March 9, 2015)
• PTSD: Should Veterans with a Diagnosis of Post-Traumatic Stress Disorder be Considered a Vulnerable Population for the Purpose of Applying Guidelines for the Protection of Human Subjects in Research? Report of a Work Group Convened by the National Center for Ethics in Health Care of the Veterans Health Administration on Behalf of the Secretary of Veterans Affairs (October 2008)
• Recruitment: FAQ on "Recruitment Only" Studies (March 12, 2012)
• Social Media: ORD Guidance for Use of Facebook and Twitter when Recruiting Research Subjects in VA Research (Guidance Under Revision. Temporarily removed on 09/26/2017)
• SSN Data Requests in DART: 
  Research requests for NDS data containing Real SSNs, submitted through the Data Access Request Tracker (DART) (Sept. 5, 2014)
• Study Team Changes: Guidance on IRB Approval of Changes in Study Team Members
• Transitioning to 2018 Requirements: ORD Guidance on Transitioning VA Human Research Studies to the Revised Federal Policy for the Protection of Human Subjects (February 8, 2019)
• VHA Directive 1200.05 General Guidance: Crosswalk Comparison of VHA Handbook 1200.05 (dated November 12, 2014) vs. VHA Directive 1200.05 (dated January 7, 2019) (guidance dated 1-9-2019)
• VHA Directive 1200.05 General Guidance: Summary of Significant Changes to VHA Directive 1200.05 (guidance dated 1-9-2019)
• VHA Directive 1200.05 General Guidance: Red-Line Version of VHA Directive 1200.05 (DRAFT) (1-8-2019)

Federal Regulations

• Final Rule (2018 Requirements): Federal Policy for the Protection of Human Subjects
• Pre-2018 Requirements: Federal Policy for the Protection of Human Subjects
• 38 CFR 17 VA- Medical
• 21CFR11 (FDA - Electronic Records and Signatures)
• 21CFR50 (FDA - Protection of Human Subjects)
• 21CFR56 (FDA - Institutional Review Boards)
• 21CFR312 (FDA - Investigational New Drug Application)
• 21CFR812 (FDA - Investigational Device Exemptions)
• 32CFR219 (DOD - Protection of Human Subjects)

Good Clinical Practice

• Guidance for Industry E-6
• Comparison of FDA and DHHS Human Subject Protection Regulations

Guiding Principles

• The Belmont Report
• The Nuremberg Code
• World Medical Association Declaration of Helsinki

VHA Handbooks

This section is currently being updated. Please check back.