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, a division of the U.S. Department of Health and Human Services, set guidelines and regulations governing research with human subjects and establish the authority granted to the IRB.
The definition of research involving human subjects is broad. At a minimum, the IRB must review research that involves:
Federal law requires review of research involving human subjects. 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 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 its efficacy in treating 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 established a requirement that all institutions accepting federal funds related to research follow the same regulations. IRBs were created to prevent another Tuskegee.
All research activities taking place on a Banner Health campus or involving Banner Health patients and employees are reviewed by an IRB.
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