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 and Other Correspondence

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

Types of Determinations

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

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.

Reporting Incidents

Get information for institutions about how to report noncompliance, suspension or termination of IRB approval and unanticipated problems to OHRP.

Submitting a Complaint

Get information about how to report allegations of noncompliance in HHS-supported research.

DCO Activity Data

Access aggregate data on several key activities performed by DCO

Compliance Oversight Archived Materials

Find archived OHRP compliance oversight materials that are maintained for reference.

Contact Us

Contact the Division of Compliance Oversight with questions about compliance.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed