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Human Research Protections
VHA is a leading organization in conducting human subjects research, and ORO is charged with ensuring the protection of research subjects who volunteer for participation. ORO conducts Combined Program Reviews, Focused Reviews, For-Cause Reviews, and provides Technical Assistance at VHA research facilities with Human Research Protection Programs (HRPP). In addition, the ORO Human Research Protection Workgroup monitors the remediation of non-compliance with HRPP requirements and ethical principles.
You can 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 (FWA) and IRB Roster Updates | OROFWA@va.gov |
Additional Links
- VHA Directive 1200.05(2) (January 7, 2019, Amended March 3, 2020, Amended January 8, 2021) - 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.
- Office of Research and Development, Office of Research Protections, Policy, and Education: The mission of VA's Program for Office of Research Protections, Policy, and Education (ORPP&E) is to protect participants in VA human research. ORPP&E is responsible for all policy development and guidance for human research protection in the VA.
