Compliance & Reporting

OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46 at http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html). In carrying out this responsibility, OHRP reviews allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations, and determines whether to conduct a for-cause compliance evaluation. DCO also conducts a program of not-for-cause surveillance evaluations of institutions, and responds to incident reports from assured institutions.

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Determination Letters tile

Determination Letters and Other Correspondence

View letters issued by OHRP related to evaluations of compliance with the human subjects protections regulations.

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Types of Determinations

View a list of determinations of noncompliance that OHRP has made in compliance oversight determination letters over the last several years.

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Evaluating Institutions

Find the procedures used by OHRP in performing compliance oversight evaluations of institutions and human subjects research that are under OHRP's authority.