Attention A T users. To access the menus on this page please perform the following steps.
1. Please switch auto forms mode to off.
2. Hit enter to expand a main menu option (Health, Benefits, etc).
3. To enter and activate the submenu links, hit the down arrow.
You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links.
Locator
Contact
Search
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.