Reporting Research Concerns and Complaints

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Research Concerns and Complaints

How to Report a Concern or Complaint

How We Respond

 

Research Concerns and Complaints

The HRPP is concerned about the safety, rights and welfare of all individuals participating in research projects at UCSF and its affiliated sites. We take all research concerns or complaints very seriously.

To resolve minor research concerns or complaints, you may prefer to speak directly with the study investigators and/or their staff. We understand that you may not wish to speak with the study investigator directly in some circumstances. We can help you whether you wish to speak with the study investigator or not.

If you have a research-related concern or complaint that we may be able to help resolve, contact our office as soon as you can.

How to Report a Concern or Complaint

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

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 to follow up your phone call with a written report in some circumstances.

Completing the Optional Reporting Form for Research Concerns or Complaints

Please complete all of the sections of the Reporting Form for Research Concerns or Complaints 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 IRB@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 mail.

Email: IRB@ucsf.edu

Fax: 415-502-1347

Mail: UCSF Human Research Protection Program
3333 California Street, Suite 320
San Francisco, California 94143-0962

Campus Mail: Box 0962

How We Respond

HRPP Followup

Staff of the Quality Improvement Unit and the members of the IRB handle the research concerns or complaints that we receive. We will review the information you have sent us and contact you. If needed, we will follow up 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 follow up on the concern or complaint you are reporting. The university provides whistleblowing 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.