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THE HUMAN RESEARCH PROTECTION PROGRAM

THE QUALITY IMPROVEMENT UNIT (QIU)
THE COMMITTEE ON HUMAN RESEARCH (CHR)

UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES

Reporting Research-Related Concerns and Complaints
(Effective November 2004)

Information for UCSF Research Participants

Brief Overview
How to Report Your Concern or Complaint
   • Making a Phone Report
   • Completing a Reporting Form for a Concerns or Complaint
   • Other Written Concern or Complaint Reports
   • How and Where to Send Concern or Complaint Reports
How HRPP Responds to Your Concern or Complaint
How You Can Contact the Study Investigator


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.

To resolve minor research concerns or complaints, you may prefer to speak directly with the study investigators and/or their staff. (See How You Can Contact the Study Investigator below.) We recognize, however, that in some circumstances you may not wish to speak with the investigator directly. We can help you at HRPP whether you wish to speak to the investigator or not.

If you have a research-related concern or complaint that we may be able to help resolve, we encourage you to contact our office as soon as you can. You may report your concern by phone, or by sending an email, fax, or letter. Please note that we also provide an optional Reporting Form for Research Concerns or Complaints. Even if you do not wish to use the Reporting Form, you may still find it to be a helpful tool as you prepare to contact us.

How to Report Your Concern or Complaint

To help us handle your report, please provide as much information as possible using one of the three reporting methods suggested below.

Making a Phone Report

You may report your concern or complaint by phone by calling the HRPP at (415) 476-1814. Please ask for the person who handles research participant concerns and complaints. In order to assure that we clearly understand your concern or complaint, we may encourage you in some circumstances to followup your phone call with a written report.

Completing the optional Reporting Form for Research Concerns or Complaints

Please complete all of the sections of this form with as much information as you feel comfortable providing. If you have questions about this form, or need assistance in completing the form, please call the HRPP at (415) 476-1814 and ask for the person handling research participant concerns and complaints. You may also contact us by email at CHR@ucsf.edu

Sending Other Written Concern or Complaint Reports (Email, Fax or Mail)

Although we encourage you to use the optional Reporting Form to report your research-related concern or complaint, you may also report your information by sending us an email, fax or US mail letter.

How and Where to send Concern or Complaint Reports

Please send all completed written reports to us by:

Email: CHR@ucsf.edu

Fax: (415) 502-1347

US Mail:
Committee on Human Research
c/o The Human Research Protection Program/UCSF
3333 California Street, Suite 320
San Francisco, California 94116

Campus Mail:
Box 0962

How HRPP Responds to Your Concern or Complaint

HRPP Followup

Staff of the Quality Improvement Unit and the members of the Committee on Human Research (CHR) handle research concerns or complaints received by the HRPP.

We will review the information you have sent us and someone from the HRPP will contact you. If needed, we will followup with appropriate actions to try and address your concerns or complaint as quickly as possible.

Confidentiality

All information will be kept as confidential as possible and will be used only to contact you to followup on the concern or complaint you are reporting. The University provides whistle-blowing protection for anyone who reports an activity that violates any regulations and policies on the use of human subjects.

How You Can Contact the Study Investigator

Please let us know if you are having difficulties contacting the investigator of a study.

If you are a study participant, most research studies have a consent form or information sheet that is given to you when you are considering whether you wish to participate in the study. The consent form or information sheet will include a “Questions” section that will explain how you can contact the study investigator directly if you wish to do so.