Research Complaint Form

OMB No. ####-####
Approved for use through ### ##, ####

Office for Human Research Protections (OHRP)
Research Complaint Form
OHRP reviews and investigates hundreds of complaints each year. Before you begin, it may be helpful for you to know the following about the types of
complaints we do and do not address:
1. OHRP
2. OHRP
3. OHRP
4. OHRP
5. OHRP

evaluates complaints about research that is conducted or supported by the U.S. Department of Health and Human Services (HHS).
evaluates complaints about research to which OHRP’s jurisdiction applies through a Federalwide Assurance (FWA).
evaluates complaints about institutions or Institutional Review Boards (IRBs) that review research conducted or supported by HHS.
evaluates complaints that, if proven, would be a violation of the regulations at 45 CFR part 46.
may refer you or your complaint to another government department, agency, or office for assessment.

Please provide as much of the following information as possible. An asterisk (*) indicates fields that are required. Submission of an
incomplete complaint or failure to submit requested information may mean that OHRP is unable to address the complaint and may lead to
closure of a complaint.
1. *Alleged Complaint Type (please check all that apply):
☐ Issues related to an Institution (not related to the IRB)
☐ Issues related to an IRB
☐ Issues or problems with informed consent (including undue influence or coercion)
☐ Issues or problems with a study
☐ Risks to subjects
☐ Failure to report an issue (e.g., to an IRB, institutional officials, or OHRP)
☐ Issues related to a researcher or research team
☐ Other
2. Name of institution(s) conducting the research or reviewing IRB (if applicable):

3. Research/Study title (if applicable):

3(a). Brief description of the study (if applicable):

3(b). IRB study number (if applicable):

3(c). Researcher’s Name (if applicable):

3(d). Name of HHS Funder (if applicable):

4. *Detailed description of the complaint:

OHRP accepts complaints submitted anonymously. OHRP asks complainants who identify themselves whether OHRP may disclose
their identity to the institution where the alleged noncompliance may have occurred.
5. First Name of person submitting this form:

6. Last Name of person submitting this form:

7. Submitter’s email:

8. Submitter’s phone number (with area code):

9. Please keep my name and contact information confidential: ☐ Yes

☐ No

If applicable, you may upload supporting documentation. Please do not upload any documents with personally identifiable information or
private health information.
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB
control number. The valid OMB control number for this information collection is 0990 -XXXX. The time required to complete this information collection is
estimated to average 30 minutes per response, including the time to review instructions. If you have comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to : U.S. Department of Health & Human Services, OS/OCIO/PRA, 200 Independence
Ave., S.W., Suite 336-E, Washington D.C. 20201, Attention: PRA Reports Clearance Officer