Content created by Office for Human Research Protections (OHRP)
Office for Human Research Protections (OHRP)
- Office of the Director
- International Activities
- SACHRP Staff Support
- Division of Compliance Oversight (DCO)
- Division of Education and Development (DED)
- Division of Policy and Assurances (DPA)
OHRP’s Statement of Organization and Functions →
Offices that constitute OHRP:
- Office of the Director
- Secretary’s Advisory Committee on Human Research Protections (SACHRP)
- International Activities
- Division of Compliance Oversight
- Division of Education and Development
- Division of Policy and Assurances
Compliance
OHRP’s Division of Compliance Oversight (DCO) evaluates, at OHRP’s discretion, written substantive indications of
noncompliance with HHS regulations—Title 45, Part 46, Code of Federal Regulations (45 CFR 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. DCO
also conducts a program of not-for-cause surveillance evaluations of institutions, and receives, reviews, and
responds to incident reports from Assured institutions.
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. It also strives to educate the general public about research participation
and human research protections.
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 Federalwide Assurances of Compliance and registration of institutional review boards.
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.