Office for Human Research Protections

From Wikipedia, the free encyclopedia
Jump to: navigation, search

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

The office's primary duty is the implementation of 45 C.F.R. 46, a set of regulations for Institutional Review Boards (IRB) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the aegis of the "Common Rule".[clarification needed]

Institutions that conduct DHHS-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 DHHS Secretary on issues of medical ethics.

See also[edit]

External links[edit]