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Submitting a Complaint

Submitting a Complaint to OHRP

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).  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.  For further details see OHRP’s guidance, "Compliance Oversight Procedures for Evaluating Institutions".

How to Submit a Complaint to OHRP: 

Complainants may submit allegations of noncompliance by e-mail, mail, or fax to OHRP’s Director of the Division of Compliance Oversight, 1101 Wootton Parkway, Suite 200, Rockville, MD, 20852 (email complaints.ohrp@hhs.gov; fax (240) 453-6909). OHRP accepts complaints submitted anonymously, and asks complainants who identify themselves to OHRP whether OHRP may reveal their identity to the institution where the alleged noncompliance may have occurred.

If you have any questions, you may contact OHRP at 240-453-6900.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 14, 2016