Serve On Boards To Review And Monitor Clinical Trials

Institutional Review Board

Federal regulations require that research projects involving human subjects, including clinical trials, be reviewed by an IRB, but you may not be aware of the exact workings of the review process, for example, that a non-scientist and a person not affiliated with the institution are required members. IRB is actually a general term used by the Federal government, so individual institutions and organizations may have their own name, such as independent ethics committee (IEC), ethical review board (ERB), and research ethics board (REB). 

• IRB Review Process: The IRB review process is in place to protect the rights and welfare of humans participating as subjects in research studies. 
  • IRB approval is required when research involving human subjects:
    • Receives federal funds either directly or indirectly.
    • Takes place at a university or hospital.
    • Tests therapies that will require U.S. Food and Drug Administration (FDA) marketing approval. 
    • Funded privately, but performed with the intention of publication or as a first step to future IRB-regulated research; in this case the IRB review is voluntary. 
  • The review occurs prior to the start of the research study and periodically throughout the study, and assesses research protocols and related materials, including (but not limited to):
    • Informed consent documents and process.
    • Investigator brochures used to provide information about the research study.
  • The IRB may also:
    • Determine whether a project is exempt from the IRB process. 
    • Require changes prior to granting approval.
    • Grant approval.
    • Deny approval. 
  • The IRB also monitors the safety of study volunteers at a local level.
  • Most changes in protocols and/or the informed consent process and other related materials will require review by the IRB prior to being implemented. 
  • An institution or organization may have its own IRB or may use an outside IRB, which may include institutionally or independently established IRBs.
  • Federal registry of IRBs is required when the IRB will review clinical trials that are:
    • Regulated by the FDA. 
    • Intended to support applications for research or marketing permits for FDA-regulated products.
    • Learn more in the Guidance for Institutional Review Boards: Frequently Asked Questions – IRB Registration
  • The FDA provides more detailed information about IRBs in the Guidance Document: Institutional Review Boards Frequently Asked Questions
• IRB Members: Members of an IRB must include at least 1 non-scientist as well as a member not affiliated with the institution or organizations forming the IRB.
  • You or members of your staff or patient community may serve as a non-scientist member of an IRB. 
    • Be aware that nurses, pharmacists, and other biomedical health professionals cannot fill the role of non-scientist even if they are a member of the patient community or your group. They can, however, still be a member of the IRB in a scientific role. 
    • The Human Health and Services Office of Human Research provides further guidance in: Recommendation on IRB Membership and Definition of Non-scientist
  • Members of your Scientific/Medical Advisory Board can also serve as members of IRBs either due to their scientific expertise or as the non-affiliated member. 
  • Due to potential conflict of interest, IRB members associated with your group may not be able to directly review a research proposal focused on your disease depending on the level of involvement in the funding of the research and design or active involvement in the clinical trial.
    • However, having members from your group on 1 or more IRB can help your group better understand the IRB and research process.
• IRB Appointments: Appointments to an IRB may differ depending on the institution or organization. It is best to contact a specific university, hospital, National Institutes of Health (NIH) Institute, and so on, to determine who appoints members to their affiliated IRB and how you or others from your group could become a potential appointee.

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