Report a Complaint
If you or your family have a complaint about how a study is being conducted, you can share your concerns with the Office of Human Subjects Research Protections, the Clinical Center Patient Representative, or submit them anonymously. Researchers who have concerns about the conduct of human subjects research can also file a complaint.
If you or your family have a complaint about how a study is being conducted, you can share your concerns with the Office of Human Subjects Research Protections, the Clinical Center Patient Representative, or submit them anonymously. Researchers who have concerns about the conduct of human subjects research can also file a complaint.
Report a Concern or Complaint About Human Subjects Research
The NIH Office of Human Subjects Research Protections (OHSRP) oversees research studies that:
- Are reviewed by the NIH Institutional Review Board (IRB), and
- Are conducted under the authority of the NIH IRB, including some studies at external sites where NIH serves as the IRB of record.
OHSRP does not oversee studies that:
- Are funded through the NIH Extramural Program, and
- Are reviewed by a non-NIH IRB.
Example: If NIH funds a study at a university and the university’s own IRB reviews the study, OHSRP does not oversee that study.
If you are not sure whether NIH is the IRB of record for your study, you may still contact us. We will review your concern and direct it to the appropriate office if needed.
If You Are a Study Participant
Step 1: Contact the Study Team
Your consent form includes contact information for the study investigator.
Contact the investigator first if you:
- Have questions about the study
- Experience a problem related to the research
- Have concerns about how the study is being conducted
Step 2: Contact OHSRP
Contact the Office of Compliance and Training in OHSRP if:
- The study team cannot resolve your concern
- You have questions about your rights as a research participant
- You want to file a research-related complain
Email: ohsrpcompliance@od.nih.gov
You may also submit a complaint using our secure online form:
You do not have to provide your name. If you would like someone to follow up with you, please include your contact information.
If You Are Participating in a Study at the NIH Clinical Center
You may also contact:
NIH Clinical Center Patient Representative
Phone: 301-496-2626
Email: ccptrep@mail.nih.gov
To report safety concerns anonymously to NIH Clinical Center leadership (available to staff, patients, and visitors):
Anonymous Safety Hotline: 866-444-8811
If You Are a Researcher or NIH Staff Member
Researchers, members of the NIH Human Research Protection Program (HRPP), and NIH staff must report concerns about possible non-compliance in human subjects research.
You may report concerns by:
- Emailing ohsrpcompliance@od.nih.gov
- Submitting a Reportable New Information (RNI) report in PROTECT
- You may also submit a complaint using our secure online form:
Anonymous reports will be reviewed and investigated as thoroughly as possible.