Submitting a Complaint About Research Involving Humans

OHRP reviews and investigates hundreds of complaints each year. Every report we receive is important, however, not every submission will result in an investigation. Before you begin, please make sure you understand the types of complaints we do and do not address to avoid delays. OHRP only addresses the following types of complaints:

• Complaints about research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).
• Complaints about research to which OHRP’s jurisdiction applies through a Federalwide Assurance (FWA). In other words, some U.S. institutions choose to give OHRP oversight over all research they conduct regardless of the source of funding.
• Complaints about institutions or Institutional Review Boards (IRBs) that review research conducted or supported by HHS.
• Complaints that, if proven, would be a violation of the regulations at 45 CFR part 46.

Note, most of the complaints received by OHRP pertain to issues that do not involve human subjects research. Often these complaints are about research that is not covered by the Common Rule or pertain to issues that are not related to research at all. In addition, OHRP does not maintain information about individual participants in HHS research or any other research.

Please see the question “Where else can I go for help with my complaint?” below to find other places to submit complaints.

OHRP recommends that you contact the human research protection office of the institution where the research was conducted, the reviewing IRB, and research team regarding complaints about potential violations prior to submitting a complaint to OHRP. Often, this information can be found in the informed consent document.

In order for OHRP to evaluate your research complaint, it is important to include the following information, when available:

• The name of the Institution conducting the research
• A detailed description of the complaint, including:
  • The name of the researcher(s)
  • The name of the research project and/or grant proposal
  • The number of the research project
  • The source of research funding

Complaints will be closed within 30 days if a request from OHRP for additional information is unanswered.

Disclosing your Identity

We recognize that you may want to maintain your confidentiality when filing a complaint. OHRP accepts complaints submitted anonymously and you may opt not to provide any identifying information (name, contact information, etc.) in the online submission complaint. You should know, however, that opting to remain anonymous may hinder OHRP from thoroughly reviewing and/or resolving the complainant's allegations.

If you chose to provide us your identifying information when filing the online submission form, OHRP will ask complainants whether OHRP may reveal their identity to the institution or IRB where the alleged noncompliance may have occurred.

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.

OHRP will review your complaint to determine if it falls under OHRP’s oversight and determines whether to conduct a for-cause compliance investigation or to use other mechanisms to address the complaint. While not every submission will result in an investigation, OHRP takes all complaints seriously.

Upon submission of a complaint, you will receive a submission confirmation notification along with a reference number for your records.

Complaints will be closed within 30 days if a request from OHRP for additional information is unanswered.

• Depending on the nature of your complaint there may be other federal offices that are better suited to receive and investigate it. For complaints about research with human participants that is conducted or supported by another federal department or agency other than HHS, please see this list of contacts: https://www.hhs.gov/ohrp/compliance-and-reporting/common-rule-agencies-contacts/index.html
• Complaints not addressed through the OHRP complaints process include, but are not limited to:
  • Complaints about non federally funded FDA-regulated research involving drugs, devices or biologics: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/reporting-complaints-related-fda-regulated-clinical-trials
  • Complaints about research integrity: https://ori.hhs.gov/complainant
  • Complaints about civil rights, conscience or religious freedom, HIPAA (e.g. medical records), patient safety and confidentiality, or breaches of protected health information: https://www.hhs.gov/ocr/complaints/index.html
  • Complaints about Medicare & Medicaid Services: https://www.cms.gov/medical-bill-rights/help/submit-a-complaint
  • Potential fraud, waste, abuse in Medicare, Medicaid and other HHS programs: https://oig.hhs.gov/fraud/report-fraud/
  • Potential fraud, waste, abuse in Social Security: https://www.ssa.gov/fraud/
  • Complaints about workplace safety: https://www.osha.gov/workers/file-complaint
  • Complaints about products and services, travel, housing, and banking: https://www.usa.gov/complaints