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700-36-Research Complaints and Concerns

Title: Research Complaints and Concerns
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The USU IRB is committed to the protection of research participants. Research participants are encouraged to express any concerns or complaints regarding their involvement in a research study.

Consent documents must include the investigator’s contact information for any questions, complaints and/or concerns the participant or legal representative may have about the research or related matters. Consent documents must also include contact information for the USU IRB. Such contact information is made available for the reporting of questions, complaints and/or concerns.

The IRB will investigate all complaints or concerns received regarding human subject research conducted under its jurisdiction. All complaints or concerns will be handled confidentially. This includes any reporting of an alleged violation of investigator compliance.

Purpose: The purpose of this policy is to describe how complaints or concerns regarding research are managed.

Procedures:

  1. Complaints received by an investigator or members of the research staff must be reported to the IRB according to 700-31: Unanticipated Problem Involving Risk to Participants or Others.

    Complaints directly reported to the IRB will be documented using the Event Reporting Form and handled according to 700-31.
  2. The IRB Chair or designee will attempt to find a suitable resolution and respond to the complaint or concern in a timely manner. As necessary, complaints may be brought to the IRB Committee for discussion and recommendation.
  3. If the concern or complaint involves possible non-compliance or research misconduct, the complaint will be handled according to 700-33: Non-Compliance and Research Misconduct.

Scope: The policy applies to research approved by the USU IRB.

Documents and Forms:

Event Reporting Form