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U.S. Department of Health and Human Services
Health Resources and Services Administration
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Policies and Procedures for the Protection of Human Subjects Participating in Research Programs Conducted or Supported by HRSA

HRSA has policies and procedures for ensuring the appropriate implementation of Department of Health and Human Services (HHS) regulations for the protection of human subjects (45 CFR part 46) participating in research programs conducted or supported by HRSA. The purpose of the policy is to: (a) provide guidance for compliance with Federal regulations for the protection of human research subjects participating in research that HRSA conducts, supports, and disseminates; (b) affirm HRSA’s commitment to protect the rights of all participants in research and delineate various levels of protection applicable to HRSA investigators, supervisors, and other stakeholders; (c) explain how to determine the appropriate procedures to support the human research protections in each HRSA program involving interventions with human subjects to ensure the safety of participants and the integrity of the data; (d) define specific responsibilities and processes for HRSA staff participating in planning, reviewing, executing, or administratively supporting research involving human participants; and (e) explain the exemption process for certain research that is exempt from human subjects research regulatory requirements.

This policy applies to all HRSA research activities that involve human participants or data use that contains identifiable private information for research conducted or supported by HRSA.

Download the full HRSA Human Subjects Protection Policy (PDF - 118 KB)