HRSA’s Office of Planning, Analysis and Evaluation (OPAE), under HRSA’s Federalwide Assurance, provides guidance and consultation to HRSA program staff on human subjects protections requirements. Human subjects protections requirements apply to all biomedical, behavioral, clinical, or other research funded wholly or in part by HRSA, whether supported through grants, cooperative agreements, contracts, other transaction awards, or conducted by HRSA staff, that collects or uses identifiable, sensitive information (with limited exceptions). OPAE coordinates with the HHS Office for Human Research Protections (OHRP), ensures deemed issuance of Certificates of Confidentiality, and represents HRSA on the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP).
The Common Rule governing Human Subjects Protection allows for limited exemptions to certain research review requirements, including review by an Institutional Review Board (IRB). This IRB exemption applies in cases where Federal research and demonstration projects are designed to examine public benefit or service programs. HRSA projects (PDF - 84 KB) that fall under this exemption are available for public viewing.
In April 2022, HRSA updated its policy to ensure deemed issuance of Certificates of Confidentiality. Please read HRSA’s Policy on Certificates of Confidentiality (PDF - 151 KB) for details.
Human Subjects Protection Administrator &
Certificate of Confidentiality Coordinator