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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.

How to Seek Whistle Blowers’ Protections:

Complainants who are employees of HHS contractors, subcontractors, grantees, and subgrantees and are concerned that an adverse action will be taken against them for reporting noncompliance that occurred in research supported by the U.S. Department of Health and Human Services, or for reporting wrongdoing with respect to a HHS-funded grant or contract, can potentially obtain whistleblower protections.  In addition to reporting the noncompliance with human subject protections to OHRP, the complainant may obtain whistleblower protections by reporting the noncompliance to entities such as the OIG or the HHS-awarding agency, or to a management official of the complainant’s employer who is responsible for investigating, discovering or addressing misconduct.  You can report non-compliance with the human subject protections to the HHS OIG by contacting the OIG Hotline at https://oig.hhs.gov/fraud/report-fraud/index.asp. Once the complainant has made a protected disclosure, if the complainant believes that an adverse action has been taken as a result of the protected disclosure, the individual may submit a whistleblower retaliation complaint to the HHS OIG.
Complainants who are HHS employees or applicants for HHS employment who believe that an adverse personnel action, or security clearance action, has been taken or threatened against you in reprisal for making a disclosure of wrongdoing, including noncompliance with human subject protections, you may submit a complaint to the HHS OIG Hotline at https://oig.hhs.gov/fraud/report-fraud/index.asp or to the U.S. Office of Special Counsel at https://osc.gov/.  

For more information about whistleblower protections, please review the Frequently Asked Questions on the HHS OIG Whistleblower Ombudsman website at https://oig.hhs.gov/fraud/whistleblower/.

NOTE: Please note that OHRP does not have the legal authority to provide whistleblower protections for complainants. 

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