Institutional Review Boards—Regulatory and Risk Management Overview

November 1, 2005 | Healthcare Risk, Quality, & Safety Guidance

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"The salient and inescapable characteristic of biomedical and behavioral research on human beings is that it is, for the most part, the use of some human beings for the purposes of other human beings."1

Research on human beings has led to lifesaving medical treatment and significantly improved quality of life for millions of individuals throughout the world. Without human subjects research, many safe and effective clinical treatments and medical technologies that are commonplace today might not exist. Many medical scientists believe that continued human subjects research, particularly gene therapy and stem cell research, holds the promise of finding safe and effective treatments for many deadly and disabling conditions and diseases, such as Alzheimer's disease, cancer, and paralysis caused by spinal cord and neurologic damage. However, without ongoing and effective oversight, human subjects involved in biomedical and behavioral research remain vulnerable to abuse, manipulation, and harm in the name of advancing medical science.

Historically, human research has been identified with sordid and horrible experiments done by the Nazis and has even been associated with the U.S. government. Examples include the infamous 40-year Tuskegee Syphilis Study of black males conducted by the United States Public Health Service (see The Tuskegee Syphillis Study: Learning from the Past); radiation experiments, such as one conducted on mentally impaired children without informed consent; and administration of psychedelic drugs to unknowing "subjects," some of whom committed suicide.2,3

Risk managers cannot change the past; however, they can and should play a role in protecting individuals who are involved in human research by ensuring the proper oversight of human subjects research conducted in their institutions. Institutional review boards (IRBs)—committees that are designated by research institutions to review, approve, and periodically...

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