What is an Institutional Review Board?
An Institutional Review Board (IRB) is a committee charged with protecting the rights and welfare of people participating in research. The IRB reviews proposed research projects involving human subjects and provides ongoing oversight to ensure regulatory compliance. Both the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (part of the U.S. Department of Health and Human Services) set the guidelines and regulations governing human subjects research and establish the authority granted to the IRB.
The definition of research involving human subjects is broad. At a minimum, the Banner Health IRB must review research that involves:
- Biomedical research
- Medical and administrative record data collection (both retrospective and prospective)
- Research that uses leftover tissues
- Health services research
- Survey research
- Behavioral research
Why does an IRB Review and Approve Research?
Review of research involving human subjects is required by federal law. Federal laws and regulations regarding research on human subjects have specific requirements for IRB and study administration.
The federal requirement for review of research by human subjects stems directly from experiences in a case known as Tuskegee. The Tuskegee Study was a federally funded study involving low-income African-American men (now considered to be a vulnerable population).
These men were studied for several decades to determine the natural history of untreated syphilis. The men were diagnosed with syphilis prior to a treatment becoming available however, they were not offered penicillin after the discovery of it’s effect on syphilis. To further compound the injustice, the men were not told they were subjects in a research study and believed they were receiving the best treatment available. Many men in the study died from complications related to syphilis.
When this breach of ethics was brought to light in the mid 1970s, the federal government instituted legal requirements requiring external oversight for research funded with federal monies. The federal government also decided to require that all institutions accepting federal funds related to the conduction of research follow the same regulations. Thus, the creation of the IRB.