HHS defines a human subject as "a living individual about whom an investigator (whether professional or student) is conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
HRSA's Office of Planning, Analysis and Evaluation (OPAE):
- Provides guidance to HRSA staff and grantees on human subjects protection requirements
- Coordinates with the Office for Human Research Protections (OHRP)
- Issues Certificates of Confidentiality (PDF - 151 KB) to HRSA funded entities conducting human subjects research, provided they comply with HRSA policy
- Evaluates HRSA grantee requests for exemptions from HHS regulatory requirements
- Represents HRSA on the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP)
All research involving human subjects that HRSA conducts or supports must meet the HHS Common Rule requirements for human subjects research. The requirements apply to research that’s:
- Fully or partially funded through HRSA
- Supported through grants, cooperative agreements, contracts, or other awards
- Conducted by HRSA staff
An Institutional Review Board (IRB) must approve all research before the start of the research, unless exempt (PDF - 84 KB). The Common Rule contains exemptions to this and other requirements. For example, federal research and demonstration projects about public benefit or service programs don’t need Institutional Review Board approval.
Contact Us
Human Subjects Protection Administrator
Email Protections@hrsa.gov