What is an IRB?

The U.S. Code of Federal Regulations addresses the protection of human research subjects and outlines the role of an Institutional Review Board (IRB). An IRB reviews research studies to assess safety, privacy, confidentiality concerns as they relate to the research that is being considered.  The IRB also determines what information should be provided to the potential research participant and approves the consent document that is to be used before the study is started. The IRB can approve or modify studies to ensure that they include proper protections, or disapprove any study that poses excess risk to a research subject. The main purpose of the IRB is to protect the rights and welfare of research subjects who participate in research studies.

Who Serves on an IRB?

According to the regulations, an IRB should have at least five members with varying backgrounds to ensure a sufficient review of the research studies.  The IRB members are qualified based on their experience and expertise and the IRB should be diverse in terms of race, gender, and cultural backgrounds.  The IRB should also have at least one member who has scientific expertise and at least one member who does not have a scientific background.

What Does an IRB Review?

The IRB reviews each research study to ensure that the risks are appropriate in relation to the benefits and that there are safeguards in place to address risks encountered in the research. The regulations requires an IRB to specifically review various aspects of a research study such as the study design, risk vs. benefit, the informed consent document and process, privacy protection, and confidentiality.

For more information please visit the U.S. Department of Health & Human Services (DHHS) website: http://www.hhs.gov/ohrp/assurances/irb/index.html