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THE COMMITTEE ON HUMAN RESEARCH

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

REPORTING AND RESPONDING TO RESEARCH-RELATED CONCERNS AND COMPLAINTS (Posted January 2005)

Brief Overview

The Human Research Protection Program (HRPP) is concerned about the safety, rights and welfare of all individuals participating in research projects at UCSF and its affiliated sites. All research concerns or complaints reported to the HRPP are taken very seriously.

Responding to Participant Concerns or Complaints

As a study investigator, you and/or your staff are obligated to make a good faith effort to promptly respond to, and to try and resolve, any study-related concern or complaint you receive or are aware of. Most often, reported concerns and complaints are minor and routine, e.g., a participant complaint about late payment for a study-related reimbursement. You do not need to report minor or routine concerns that can be quickly resolved to the CHR.

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Reporting a Significant Participant Concern or Complaint to the CHR

Investigators must report any significant complaint/concern to the CHR as a study-related incident. Any complaint/concern that may adversely impact a participant’s or a potential participant’s safety, rights or welfare should be considered significant. Additionally, any complaint/concern, which requires a change to the study protocol or consent form, should also be considered significant.

When Concerns or Complaints are Reported Directly to the CHR

The CHR is obligated to receive and respond to concerns and complaints reported to us directly in a number of different ways (e.g., by calling the office, by filling out the Reporting Form for Research Concerns or Complaints, by sending an email or by sending a letter) and from a number of different sources (e.g., actual and potential participants in your study(ies), the public, faculty, staff, and government agencies). When this occurs, the CHR will try and resolve minor concerns or complaints with the complainant informally, often referring the participant back to you or your study coordinator. If the CHR judges the concern or complaint to be significant it must be investigated in a more formal manor.