Policy 807: Research Complaints and Concerns

Policy

The University of Rochester IRB is committed to the protection of research participants. Research participants are encouraged to express any concerns or complaints regarding the 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 OHSP office. Such contact information is made available for the reporting of questions, complaints, and/or concerns. Information about how to report complaints or concerns is also provided on the IRB website. Additionally, OHSP provides a form for reporting complaints or concerns on the OHSP website.

OHSP and the IRB will investigate all complaints or concerns received regarding human subject research conducted under its jurisdiction. All complaints or concerns will be handled in a confidential manner. This includes any reporting of an alleged violation of investigator compliance.

Procedures

1. Handling of Complaints Received by OHSP and/or the IRB

• Complaints received by an investigator or members of the research staff must be reported to the IRB according to OHSP Policy 801 (Unanticipated Problem Involving Risks to Subjects or Others).
• Complaints directly reported to the IRB or OHSP will be documented using the Report Form for Research Concerns or Complaints and handled according to OHSP Policy 801 (Unanticipated Problems Involving Risks to Subjects or Others).
• The IRB Director, OHSP Specialist or designee will attempt to find a suitable resolution and response to the complaint or concern in a timely manner. As necessary, complaints may be brought to the IRB for discussion and recommendation.
• If the concern or complaint involves possible non-compliance or research misconduct, the complaint will be handled according to OHSP Policy 803 (HRPP and Non-Compliance).