The Human Research Protection Program (HRPP) is concerned about the safety, rights and welfare of all participants involved in research studies at Brown and its affiliated sites that are reviewed by Brown’s Institutional Review Board (IRB). Research participants, their family members, or anyone else may have complaints, concerns, or questions about a Brown research study. All complaints or concerns reported to the HRPP are taken very seriously. The person making a complaint or reporting a concern does not have to identify themselves, unless they would like us to contact them to gather more information or to hear how we may have addressed their concern.

Some research complaints or concerns (for example, regarding missed compensation), may be easily addressed by speaking directly with the study investigators and/or study staff. We understand, however, that in some circumstances you may not wish to speak directly with the study investigator(s).

How to Contact the Study Staff
Most research studies have a consent document that you, as a study participant, may have read or signed when you considered whether you would like to enroll in the study. The consent document included a section called “Contact Information” or “Who Can I Talk To If I Have Questions About This Study” that explains how you can contact the study team directly if you wish to do so. Please let us know if you are having difficulties with this process.

To Contact the HRPP
Complaints, concerns, or questions may be directed to the HRPP online, by phone, or in writing.

If available to you, the following information will help us begin working to resolve your concern:

1. The name of the study,
2. The IRB study number (listed on a flyer – for example STUDY04), and
3. The Principal Investigator’s name.

This information will be helpful – but is not required to communicate a complaint, concern or question.

How to Report
You may choose to report a complaint, concern or question in any of the ways listed below:

1. Complete the confidential HRPP Online Reporting Form by clicking the button below

   

    

2. Confidentially e-mail Brown leadership overseeing research compliance and integrity concerns: the Senior Director of the Office of Research Integrity, the Associate Vice President for Research, or the Vice President for Research who serves as Brown’s Institutional Official for human subjects research;
3. Submit through EthicsPoint, Brown’s third-party anonymous reporting website, or call them toll-free 877-318-9184.
4. E-mail the HRPP at [email protected].
5. Call the HRPP at (401) 863-3050 or toll-free 1-866-309-2095. These phone lines are monitored Monday – Friday 8:30 a.m. - 5:00 p.m.
6. Write to the HRPP at the following address:
   Brown University
   Human Research Protection Program
   Attn: Reporting
   Box 1986
   350 Eddy Street
   Providence, RI 02912

How HRPP Responds to Your Complaint or Concern

HRPP Follow-up:
Select HRPP staff and IRB members handle research complaints or concerns. We will review the information you have sent us and someone from the HRPP will contact you. If needed, we will follow up with appropriate actions to try and address your complaint or concern as quickly as possible.

Confidentiality:
All information will be kept as confidential as possible and will only be used to contact you to follow up on your complaint or concern. Brown provides whistle-blower protection for anyone who reports an activity that violates any regulations and policies involving human subjects research.