8.2 IRB Review of Study Related Complaints

1.0 Purpose

The purpose of this policy and procedure is to describe the procedures for reporting complaints to the IRB and the process for review of complaints.


2.0 Policy

  • 2.1. It is policy of the Organization that complaints involving the human research protection program be promptly reported to the IRB and appropriate Organizational officials, and be investigated and resolved as appropriate. For the purposes of this policy “complaints” includes problems, concerns, or questions raised by current, prospective, or post-research participants or their designated representatives.
  • 2.2. It is the policy of the Organization that findings of serious or continuing noncompliance and suspensions or terminations of IRB approval as a result of a complaint will be promptly reported to OHRP, FDA and sponsors or funding agency heads in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

3.0 Reporting Complaints to the ORA

  • 3.1. Complaints may be received by the Principal Investigator, other investigators, study staff, IRB members, IRB staff, the Research Subject Advocate, or any other Organizational officials.
  • 3.2. Complaints may also be received through the IRB website, utilizing the “Report a Problem or Complaint” tab, or University of Nebraska’s ethics hotline (EthicsPoint) at www.nebraska.ethicspoint.com.
  • 3.3. Any complaint that is received by the investigator or study staff that involves risk to participants or others, or changes the risk-potential benefit profile of the study, or which cannot be resolved by the investigator must be promptly reported to the IRB.
  • 3.4. Any complaint that is received by the investigator or study staff that does not involve risk to participants or others, or does not change the risk-potential benefit profile of the study, and that is resolved by the investigator should be submitted in a summary format to the IRB for consideration at continuing review.

4.0 ORA Procedures for Reviewing Complaints

  • 4.1. Complaints received by the IRB, or reported to the IRB by the investigators will be reviewed by the appropriate IRB Administrator. Additional information will be obtained from the complainant, the study documents, the investigator or research staff, or from other sources as appropriate.
  • 4.2. Based on this initial review, in consultation with the Executive Chair or designee, the IRB Administrator will determine:
    • 4.2.1. Whether the complaint represents an allegation of non-compliance, an adverse event, or an unanticipated problem involving risk. If so, the complaint will be handled in accordance with HRPP policy 8.1 (IRB Review of Adverse Events or Adverse Device Effects), 8.3 (IRB Review of Unanticipated Problems Involving Risk to the Subject or Others), or 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
    • 4.2.2. Whether the complaint involves risk to participants or others, or changes the risk-potential benefit profile of the study. If so, the complaint will be reported and reviewed by the full IRB at a convened meeting (HRPP policy 2.2: Full IRB Review).
    • 4.2.3. Whether additional actions need to be taken immediately to protect the rights and welfare of human subjects, in accordance with HRPP policy 8.6 (Study Hold, Suspension, and Termination) or section 5.2 below.
  • 4.3. The IO will be notified of all complaints which involve risk to participants or others, or which change the risk-potential benefit profile of the study.
  • 4.4. The PI and other involved individuals will be promptly notified of the concerns expressed in the complaint, unless such notification would compromise handling of the complaint.

5.0 IRB Review of Complaints

  • 5.1. Complaints that do not involve risk to participants or others, or do not change the risk-potential benefit profile of the study are reported in aggregate at continuing review, and will be considered by the IRB in determining whether the research continues to satisfy the criteria for approval.
  • 5.2. Complaints that involve risk to participants or others, or change the risk-potential benefit profile of the study, or which cannot be resolved by the investigator will be reviewed by the full IRB at a convened meeting. The IRB will determine:
    • 5.2.1. Whether the complaint constitutes noncompliance per HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).
    • 5.2.2. Whether the complaint constitutes an unanticipated problem involving risk per HRPP policy 8.3 (IRB Review of Unanticipated Problems Involving Risk to the Subject or Others).
    • 5.2.3. Whether the research continues to satisfy the criteria for approval under 45 CFR 46.111, 21 CFR 56.111, and HRPP policy 2.5 (Criteria for IRB Approval).
    • 5.2.4. Whether further actions are necessary to protect the rights and welfare of human subjects. Such actions may include (but are not limited to):
      • 5.2.4.1. Requiring modification of the research protocol or the consent form
      • 5.2.4.2. Notification of current participants if such information may relate to participants’ willingness to continue to take part in the research, with or without requiring re-consent.
      • 5.2.4.3. Requiring additional information be provided to past participants.
      • 5.2.4.4. Modification of the continuing review schedule.
      • 5.2.4.5. Monitoring of the research or the consent process.
      • 5.2.4.6. Study hold, suspension or termination.
      • 5.2.4.7. Referral to other organizational entities.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED JANUARY 19, 2018

 INITIAL JANUARY 20, 2016