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Human Research Protections
The ORO Human Research Protections (HRP) Workgroup’s oversight activities are designed to foster VA medical facility adherence to laws, regulations, and polices governing research involving human subjects and strengthen protections for human research subjects. To accomplish this, the HRP Workgroup conducts proactive evaluations of VA medical facility Human Research Protection Programs; investigates, or provides oversight of investigations into, suspected lapses in the protection of human research subjects; and provides oversight of VA medical facility efforts to remediate serious or continuing noncompliance involving human subjects research.
You may email ORO for human subjects research related matters at:
| Human Research Protection Program | OROHRP@va.gov |
| Research and Development Committee | OROCROW@va.gov |
| Federalwide Assurance (FWAs) | OROEDA@va.gov |
Additional Links
- VHA Directive 1200.05(3) (January 7, 2019, Amended March 3, 2020, Amended January 8, 2021, Amended July 13, 2023) - Requirements for the Protection of Human Subjects in Research
- Federal Policy for the Protection of Human Subjects (2018 "Common Rule") (January 19, 2017)
- 38 CFR 16 – VA regulations for human subject research protections, with informed consent and IRB regulations combined in one part.
- 45 CFR 46 – HHS regulations for human subject protections, with subparts for pregnant women/fetuses/neonates, prisoners, and children. Regulations are overseen by the HHS Office for Human Research Protection (OHRP).
- 21 CFR 50 – FDA regulations for human subject protections, including informed consent.
- 21 CFR 56 – FDA regulations for Institutional Review Boards (IRBs), including the review of research.
- 21 CFR 312 - FDA regulations for the use of investigational drugs
- 21 CFR 812 - FDA regulations for the use of investigational devices
- Office of Research and Development - Enterprise Protections, Regulatory, Outreach, and Systems (ePROS): ePROS supports the VA mission through protection of VA research staff and participants and through development and management of VHA's research regulatory policies.
Power Point Slides for the PRIM&R AER Conference, December 6, 2023.
A Dialogue With the VA, Karen Jeans, Ph.D., CCRN, CIP; Molly Klote, MD; Kristina Borror, Ph.D.
