General Administration |
Human Research |
Merit Review |
Off-site Research |
Draft Guidance Documents
MOU Guidance: Checklist for use in Developing a Memorandum of Understanding (MOU) between a VA facility and an Affiliated IRB: Memo | MOU (Updated January 22, 2016)
- 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) New!
- 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)
Good Clinical Practice
NOTE: These Handbooks are are available for download on the VHA Publications website. ORD Handbooks are in the 1200 series.
Requirements for the Protection of Human Subjects in Research
The Department of Veterans Affairs (VA) is one of seventeen Federal departments and agencies that have agreed to follow the Federal Policy for the Protection of Human Subjects (Common Rule), effective June 18, 1991 (56 Federal Register (FR) 28001). This policy is incorporated in title 38 Code of Federal Regulations (CFR) Part 16. This Veterans Health Administration (VHA) Handbook defines the procedures for implementing 38 CFR Part 16 and other applicable Federal requirements for the protection of human subjects, and defines changes to the Human Research Protection Program accreditation policy.
Inclusion of Women and Minorities in Research
This Veterans Health Administration (VHA) Handbook defines the requirements regarding the inclusion of women and minorities in Department of Veterans Affairs (VA) research.