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HRPP Manual Section 9-4

Subject Complaints

Individuals are encouraged to inform the Michigan State University (MSU) Human Research Protection Program (HRPP) and/or the Institutional Review Board (IRB) when they feel that they may have been harmed or put at risk by their participation in a research study or treated in a way that they find inappropriate. This includes individuals who may have been recruited to participate in a study but decided not to participate. The IRB takes all subject complaints seriously.

Complaints may be identified in a number of ways, including a complaint:

  • Made by an individual directly to the HRPP, IRB, IRB Reliance, or Compliance office, the Office of Research Regulatory Support, or to another committee, department, or official (e.g., MSU Misconduct Hotline)
  • Identified through the IRB continuing review of ongoing research (when required)
  • Discovered during compliance reviews (post approval monitoring) conducted by the Compliance office
  • Reported by the study sponsor’s monitoring entity

Individuals who wish to report complaints directly to the HRPP or IRB may do so (e.g., through a telephone call, or email). Information such as a principal investigator (PI) name and/or study title is needed to identify the research study for corrective actions, if needed.

While individuals may report complaints anonymously, if they wish, the HRPP may not be able to promise complete anonymity. For example, information provided by the subject could indirectly identify them.

The HRPP may also be required to share the complaint with others outside the HRPP, such as in the following circumstances:

  • Information is shared that must be reported under the MSU University Reporting Protocols and/or other mandatory reporting requirements.
  • If the complaint or complainant indicates an immediate threat of harm to the subject or others that is unaddressed by the IRB protocol or study team.
  • If MSU has entered into reliance for review of the associated study, the complaint must be shared with the Reviewing IRB.

The Office of General Counsel will be consulted with any questions about confidentiality.

External IRBs

If MSU is relying upon an External (non-MSU) IRB for review of the associated study, the PI or study team must report the complaint following the External IRBs requirements. Reporting to MSU HRPP is still required and follows the process described in HRPP Manual 8-11 “External IRB Submissions” or 8-11-A “External IRB Submissions Involving Henry Ford Health Employed Principal Investigators.”

Exempt Studies and Non-Exempt Studies Reviewed by an MSU IRB

If a research subject or potential research subject complains to the PI or to any member of the research team, the PI must report the complaint to the IRB office if the complaint indicates any of the following:

If reporting is needed, the PI or research team should promptly submit information about the complaint through a report of new information in the MSU IRB online system. The report should include a description of the subject complaint and the actions taken to resolve the issue. The complaint need not be resolved to be reported. For urgent situations, the PI or research team may also reach out directly to the MSU HRPP by phone (517-355-2180) or email (irb@msu.edu).  

For exempt studies, the process in HRPP Manual 4-1 “Applicability,” for determining the appropriate IRB for non-exempt human subject research will be followed to determine the appropriate MSU IRB to review the complaint.

The IRB chair, in consultation with the HRPP director when appropriate, evaluates complaints upon receipt and, if needed, arranges for review by an MSU IRB.

When reviewing complaints, the following should be taken into consideration:

  • Was any subject put at risk?
  • Was the investigator following the research study’s approved protocol?
  • Does this complaint warrant a change in the research study?
  • Does immediate action need to be taken?
  • Does the IRB chair need to consult with IRB members to determine appropriate resolution?

The IRB chair will evaluate each subject complaint as soon as possible as a potential:

If the IRB chair deems it is warranted to protect subjects, they may suspend the research study pending review by the IRB. See HRPP Manual 9-3 “Termination or Suspension of Research.” Once the complaint is reported, the IRB chair will mediate discussions between the investigator and the complainant, if applicable, in order to resolve the issue.

The IRB chair will determine whether the complaint has been resolved or whether the complaint  should be brought to the convened IRB to decide what additional action, if any, needs to be taken. This decision will follow the requirements in HRPP Manual 9-1 “Unanticipated Problems Involving Risks to Subjects or Others” and/or 9-2 “Noncompliance.

The IRB will work with the PI to resolve the complaint. Once the complaint is resolved, a complainant may be informed that review of the complaint has concluded and that corrective actions have been taken (if any), but they may not receive specific details. The process for sharing the outcome with a complainant is subject to the nature of the complaint and confidentiality considerations. The IRB will not typically share the specific details about the outcome with the complainant.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 3-3-2005. Revision 1 approved by VP Research & Graduate Studies on 5-6-2008. Revision 2 approved by VP Research & Graduate Studies on 7-22-2011. Revision 3 approved by Assistant VP Regulatory Affairs on 12-10-2015. Revision 4 approved by Assistant VP Regulatory Affairs on 12-6-2021. Revision 5 approved by Associate VP Research Regulatory Support on 11-28-2025.

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