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Human Subjects Protection

The Office for Human Research Protections (OHRP)

The OHRP provides leadership and oversight on all matters related to the protection of human subjects participating in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

NIH Office for Human Subjects Research (OHSR)

The OHSR was established to help National Institutes of Health (NIH) intramural research program investigators understand and comply with the ethical guidelines and regulatory requirements for research involving human subjects.

NIH Office of Extramural Research

This site provides information about the HHS and NIH requirements and resources for the extramural community involved in human-subjects research. For more information please visit

The U.S. Food and Drug Administration (FDA)

The FDA is the Federal agency charged with the regulatory oversight of foods and drugs with respect to safety and efficacy. Effective regulation is based on scientific evidence regarding drug actions and effects, both therapeutic and adverse. Therefore, the NIH and FDA share interest in many activities related to basic and clinical science in the interest of promoting and protecting the public health. The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human clinical research trials regulated by FDA. For more information on FDA’s Good Clinical Practice guidelines visit

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This page last updated: October 6, 2010