Human Research
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QUESTIONS: For policy and guidance questions contact VHA CO ORD Regulatory at VHACOORDRegulatory@va.gov. |
Draft Guidance Documents
- Electronic Mail and Texting: Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research (July 28, 2017)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)
- Azure Rights Management Services - IRB and R&D Committee Considerations for Use of Azure Rights Management Services (RMS) in VA Research (October 25, 2019)
- 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)
- E-Cigarettes/ENDS: Notification Alert: Research Involving E-Cigarettes/ENDS (October 2, 2019)
- 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)
- Fetal Tissue: Restriction on Use of Fetal Tissue for All VHA Research Studies (August 28, 2019)
- 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
Guiding Principles
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Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.
Any health information on this website is strictly for informational purposes and is not intended as medical advice. It should not be used to diagnose or treat any condition.