Part II of a series on proposed changes to the common rule: background on the common rule and the IRB process

I recently had the opportunity to interview John Stillman, the Director of the Institutional Review Board for the University of Utah, to ask him his thoughts on the Advanced Notice of Proposed Rulemaking (“ANPRM”) for changes to the Common Rule.  This post will focus on the background he provided on the Common Rule and the Institutional Review Board process.

John suggested that perhaps the easiest way to understand the Common Rule is to understand what prompted its creation.  The now infamous Tuskegee syphilis study took place between 1932 and 1972.  The U.S. Public Health Service was interested in studying the progression of syphilis in 600 black men in Tuskegee, Alabama.  Then men did not provide informed consent, and were told they were being treated for “bad blood.”  The story turns truly ugly when, in 1947, penicillin was recognized as the drug of choice for treatment of syphilis but the men remained entirely untreated.

In response to the study, Congress passed the National Research Act of 1974.  The Act established a commission, tasked with assessing the state of human subjects research in the United States and what should be done to improve a system that was seen as not appropriately protecting people.  The result of that commission was the Common Rule, codified at 45 C.F.R. § 46 et seq.

The Common Rule requires that entities that receive federal government funding form Institutional Review Boards (“IRB”), which serve as a kind of peer review model to ensure compliance with standards for human subjects research.  IRB committees are comprised of individuals with appropriate expertise designed to review studies and ensure that they meet the regulatory requirements and are ethically acceptable.  At the University of Utah, IRB committees oversee both social/behavioral and biomedical studies.

Thanks John for this helpful background into the Common Rule and IRBs.  In the next post of this series, we’ll hear what John has to say about some of the ANPRM’s proposed changes to the informed consent process for human subject research.

– Kim Child