Human Subjects 

About the Institutional Review Board at UMMS 

"Institutional Review Board" is a generic term, the board has different names at different institutions. Here at UMMS it is called the Committee for the Protection of Human Subjects in Research.

When you are ready to design a research project, you should obtain a copy of the Guidelines for the Preparation of Protocols for Review by the Committee for the Protection of Human Subjects in Research. These detailed instructions are available from the Research Subjects Office, 6-4261. The Research Subjects Office will also answer any questions you may have about the process

What is Research? 

Research may be defined as a systematic investigation designed to develop or contribute to generalizable knowledge. Clinical practice differs from research in that its goal is to enhance the well-being of individual patients. Investigational practice is defined as a therapeutic, diagnostic, or preventive procedure or modality performed or administered with the intent and reasonable prospect of yielding a direct health-related benefit to the patient, but which differs from customary practice. Examples are: innovative cancer therapy, the use of new techniques or tests, the use of new drugs or devices, or the use of FDA approved drugs or devices in a manner that differs substantially from approved uses. When the outcomes of this investigational practice are collected from individual patients, analyzed, and published, it becomes research as well as treatment. In general, whenever an investigational practice is employed it should be made part of a research protocol designed to establish its safety and effectiveness.

Research involving human beings and having any of the following characteristics may not be initiated until approved by the IRB: 1) research conducted at the University of Massachusetts Medical School (UMMS); 2) research sponsored by UMMS; 3) research conducted by or under the direction of faculty, staff, or students of UMMS, no matter where done; 4) research involving the use of patient records maintained by faculty or staff of UMMS.

Purpose of IRB Review 

The goal of the IRB review process is to protect the rights and welfare of those individuals who contribute to the research process by participating as subjects. In protecting the research subject, the IRB also protects the institution and the researcher from the potential harmful consequences of an inadequate consent process or the exposure of the subject to excessive risk.

The IRB reviews each research plan and consent process in order to safeguard the rights and welfare of human subjects. It must determine that each study conforms to ethical standards including: A reasonable balance of risks and anticipated benefits; adequate provisions for informed consent; and equitable selection of subjects. The IRB will review the human subjects application and decide what type of review be applied to the application.

Full Committee Review 

If an application meets Full Committee requirements, copies will be sent to all Committee members one week before the Committee meeting for review. IRB meeting dates and deadline dates are available by clicking on "Meeting Dates & Deadlines" to the left. Two primary reviewers will be assigned to the application which will be reviewed at a Full Committee meeting. At the IRB meeting each application is discussed and any points of concern are recorded. Investigators are asked to be available on pager during the time of the meeting in case the Committee wishes to discuss the application with him or her. The Principal Investigator (PI) will be given a copy of all Committee concerns. All committee concerns must be addressed and submitted to the IRB by the PI before approval is granted.

more about IRB reviews

Thank you for visiting our website. If we can be of further assistance please phone us at (508) 856-4261 or email danielle.pichette@umassmed.edu.