Institutional Review Board (IRB)

Overview

An institutional review board (IRB) is defined as “a committee whose primary responsibility is to protect the rights and welfare of human research participants” (Bankert & Amdur, 2006, p. 24).1  The Code of Federal Regulations (45 CFR 46.102) specifies that a human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” Research constitutes a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102).

In protecting the rights and welfare of human research participants, IRBs should carry out their duties with three ethical principles in mind, as outlined in the Belmont Report:

1) Respect for Persons
  • IRBs should ensure that human subjects are treated as autonomous agents, and, that those with diminished autonomy (e.g., children, prisoners) are protected. Related IRB duties include ensuring that appropriate standards for voluntary, informed consent are followed in research.
2) Beneficience
  • IRBs should ensure the well-being of human subjects and protect them from harm. In so doing, IRBs review research to ensure that it is carried out in such a way that benefits are maximized while any possible harms are minimized.
3) Justice
  • IRBs should ensure that the benefits of research are not unfairly distributed and the burdens not disproportionately borne. IRBs might recognize violations of this principle when members of a certain population, such as prisoners, are recruited as research subjects even though the benefits of research would apply to other populations, or if members of a certain population are excluded as potential research subjects even though the benefits of the research could apply to them.

 
IRB review of human subjects research is required for the receipt of federal grant funding and is also often required by other sponsors who offer grant aid to support research activities. Academic journals and conference organizers may also require IRB approval for publication and presentation. Visit the related page, “When to Submit an IRB Application.”

MMA has entered into an agreement with Bridgewater State University (BSU) to utilize the IRB at BSU.

New to working with an IRB? A July 2017 post by Public Responsibility in Medicine and Research (PRIM&R) is helpful to demystifying the IRB process. The MMA Office of Instituitional Effectiveness (OIE) is here as a resource to you as you work on your submission! Contact OIE when initiating any IRB submission (e.g., new application, amendment, renewal, adverse event).

1/ Bankert, E., & Amdur, R. (2006). Institutional review board: Management and function (2nd ed.). Burlington, MA: Jones & Bartlett Learning.