Reporting Research Complaints and Concerns
The Human Research Protection Program (HRPP) is concerned about the safety, rights and welfare of all individuals participating in research studies at UMass and its affiliated sites that are reviewed by the UMass Medical School Institutional Review Board (IRB). Complaints, concerns, or questions may be raised by research subjects (past, present and potential), family members, designated spokespersons, or anyone. All research concerns or complaints 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 to hear about steps we have taken to address the complaint or concern.
To resolve minor research concerns or complaints (for example, concerns about payments), you may prefer to speak directly with the study investigators and/or their staff. We recognize, however, that in some circumstances you may not wish to speak with the investigator directly. We can help you decide whether you wish to speak to the investigator or not.
How to Contact the Study Staff
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. Please let us know if you are having difficulties contacting the investigator of a study.
To Contact the HRPP
Complaints, concerns, or questions may be provided to the HRPP by phone or in writing.
If available to you, the following information will help us begin working to resolve your concern:
- The name of the study
- The IRB study number (listed on the research consent form – for example H0001234)
- The Principal Investigator’s name
This information will be helpful – but is not required to communicate a complaint, concern or question. The online form is also helpful to gather the information
How to Report Concerns
You may choose to report a complaint, concern or question in any of the ways listed below.
Submit through the online HRPP Feedback Form:
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 (508) 856-4261 and ask for the person handling research participant concerns and complaints. You may also contact us by email at email@example.com
Phone calls will be answered by the IRB staff, who will direct your question: (508) 856-4261
This line is monitored Monday – Friday 8:00 a.m.- 4:30 p.m.
The Human Research Protection Program/UMMS
Attn: Margaret Koziel, MD
362 Plantation Street, Ambulatory Care Center, AC7-041
Worcester, MA 01605
How HRPP Responds to Your Concern or Complaint
A staff member from Quality Improvement and the members of the Institutional Review Board 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 follow up 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 follow up on the concern or complaint you are reporting. UMMS provides whistle-blowing protection for anyone who reports an activity that violates any regulations and policies on the use of human subjects.