The federal regulatory agencies listed below have specific regulations or requirements with regard to research with human subjects in the United States.
Office for Human Research Protections (OHRP)
OHRP is a government agency that provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). They accomplish this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.
- Federal Policy for the Protection of Human Subjects (‘Common Rule’)
- Regulation 45 CFR 46 (Common Rule Requirements)
- The effective date for the revised Common Rule (2018 Requirements) was January 21, 2019.
- Educational Videos about HHS Regulations
- Educational Videos about Research Participation (available in English and Spanish)
Food and Drug Administration (FDA)*
The FDA is a government agency operating under the U.S. Department of Health and Human Services (HHS). The FDA regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
- Comparison of FDA and OHRP Regulations
- Regulations Relating to Good Clinical Practice and Clinical Trials
- Information Sheets
National Institutes of Health (NIH)
The NIH is the primary agency of the U.S. government responsible for biomedical and public health research.
National Science Foundation (NSF)
The NSF is a U.S. government agency that supports fundamental research and education in all the non-medical fields of science and engineering. Its medical counterpart is the NIH.
Department of Veteran’s Affairs (VA)
The VA’s Office of Research & Development as specific federal regulations for conducting research at VA hospitals and institutions.
- VHA Directive 1200.05 is the National VA Policy that describes the requirements for the protection of human subjects in VA research.
The U.S. Department of Health and Human Services (HHS) OCR enforces federal civil rights laws, conscience and religious freedom laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, and the Patient Safety Act and Rule, which together protect your fundamental rights of nondiscrimination, conscience, religious freedom, and health information privacy.
In addition, if the research is funded by any of the below federal agencies, the IRB Office has created the investigator checklist HRP-318 WORKSHEET Additional Federal Agency Criteria to assist in complying with each of these department’s specific regulations. This checklist must be completed by the investigator and submitted with the New Study application in eIRB+.
- Department of Defense (DOD)
- Department of Education (ED)
- Department of Energy (DOE)
- Department of Justice (DOJ)*
- Environmental Protection Agency (EPA)
*Seventeen federal agencies have adopted the revised Common Rule. The Food and Drug Administration (FDA) and Department of Justice (DOJ) have not signed on to the Common Rule at this time. Any research subject to FDA regulations or sponsored by either agency will continue under the pre-2018 regulatory requirements. However, the FDA is required to harmonize with the Common Rule whenever permitted by law.