Office for Human Research Protections

Office for Human Research Protections

The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services that deals with ethical oversight of clinical research conducted by the department, mostly through the National Institutes of Health.

The office's primary duty is the implementation of 45CFR46, a set of regulations for Institutional Review Boards that directly mirrors the U.S. Food and Drug Administration regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the aegis of the "common rule."

Institutions that conduct Department of Health and Human Services-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ethics, and advises the Secretary on issues of medical ethics.

See also

References

v · d · eAgencies of the United States Department of Health and Human Services
Secretariate staff offices
Office of the Secretary of Health and Human Services · Office of the Deputy Secretary of Health and Human Services · Office of Inspector General
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Assistant Secretary for Health
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