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Clinical Trials 101

The Institutional Review Board (IRB)

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An Institutional Review Board (commonly referred to as an "IRB") protects the rights and welfare of people who participate in a clinical trial.

To accomplish this mission, IRBs ensure that the

  • Physical, psychological and social risks participants in the trial are minimized. If risks are present, the IRB makes sure they are justified by the importance of the research and/or the knowledge to be gained from such research.
  • Potential and participating subjects are adequately and appropriately informed of the nature of the research, the risks involved and their rights as research subjects.

Regulations of the Food and Drug Administration offsite link (FDA) and Department of Health and Human Services offsite link (specifically Office for Human Research Protections offsite link) empower IRBs to approve or disapprove research, or to require modifications in planned research prior to approval.

IRBs are usually composed of at least five members.IRBs are composed of medical professionals and researchers, as well as at least one community member who is not affiliated with the institution or in the immediate family of a person affiliated with the institution. 

Members must have enough experience, expertise, and diversity to make an informed decision about the following subjects:

  • That the research is ethical
  • That informed consent is sufficient
  • Appropriate safeguards have been put in place to protect people who participate. 

 


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