THE QUALITY IMPROVEMENT UNIT (QIU)
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
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
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
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
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:
Fax: (415) 502-1347
Committee on Human Research
c/o The Human Research Protection Program/UCSF
3333 California Street, Suite 320
San Francisco, California 94116
How HRPP Responds to Your Concern or Complaint
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.
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.