- Office for Human Research Protections
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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
- Human experimentation in the United States
- Institutional Review Board
- Medical ethics
- Declaration of Helsinki
- OHRP web site
References
Agencies 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 GeneralOrganizations under the
Assistant Secretary for HealthOffice of the Assistant Secretary for Health · Public Health Service · Office of Public Health and Science · Administration for Children and Families · Administration on Aging · Agency for Healthcare Research and Quality · Agency for Toxic Substances and Disease Registry · Centers for Disease Control and Prevention · Centers for Medicare and Medicaid Services · Food and Drug Administration · Health Resources and Services Administration · Indian Health Service · National Institutes of Health · Substance Abuse and Mental Health Services Administration · Public Health Service Commissioned Corps (Surgeon General)
Programs Categories:- United States government stubs
- Clinical research
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