OHRP Fact Sheet
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.
Compliance
OHRP’s Division of Compliance Oversight evaluates all written substantive indications of noncompliance
with HHS regulations—Title 45, Part 46, Code of Federal Regulations (45 CFR part 46). OHRP asks the
institution involved to investigate the allegations and to provide OHRP with a written report of its
investigation. The Office then determines what, if any, regulatory action needs to be taken to protect human
research subjects.
Education
OHRP’s Division of Education and Development provides guidance to individuals and institutions
conducting HHS-supported human subject research; conducts national and regional conferences; participates
in professional, academic, and association conferences; and develops and distributes resource materials in an
effort to improve protections for human research subjects. OHRP also helps institutions assess and improve
their human research protection programs through quality improvement consultations.
Policy and Assurances
OHRP’s Division of Policy and Assurances prepares policies and guidance documents and interpretations of
requirements for human subject protections and disseminates this information to the research community.
The Division also administers the assurances of compliance.
Secretary’s Advisory Committee
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) advises the HHS Secretary
on issues of human subject protections. OHRP’s director serves as the Executive Secretary for SACHRP, and
the Office provides technical and logistical support to the Committee.
International Activities
From the Office of the Director, OHRP provides training to institutions involved in international research, to
help ensure that ethical protections are afforded to those who participate in research outside the United
States. The Office also provides quality improvement assurance consultations to international institutions.
September 2005
Last revised: April 13, 2009
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