Institutional Review Board (IRB)

In accordance with the Federal Policy on the Protection of Human subjects (DHHS Policy 45 CFR 46, FDA policy 21 CFR Parts 50 and 56), the University of Massachusetts Amherst is responsible for protecting the rights and welfare of human subjects of research conducted by, or under the supervision of, its faculty, staff and students.   The Institution maintains an Institutional Review Board, a federally mandated committee, which reviews all sponsored research involving human subjects. Unsponsored research is currently reviewed by local review boards. 

The IRB's charge is to ensure that the risks accompanying the research never outweigh the value of human life.  In its review of projects involving human subjects the IRB seeks to balance the risks to the subjects against the scientific knowledge to be gained and the potential benefits to the subjects and/or society, as well as ensure that all projects conform to the regulations and policies set forth by the DHHS and FDA as well as state regulations.

Funded Research is reviewed at one of three levels depending on the nature of the study. See Levels of Review for more information.

The Standard Operating Procedures (SOPs) describe the IRB committee structure, the review process, Adverse Event reporting, how to record changes to protocols and Informed Consent documents, record keeping and Institutional Policies relating to human subjects.

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