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. 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).
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