Part V of a series on proposed changes to the common rule: proposed excused categories

Apr 01, 2012 | Labs Blog

This post serves as the last of the series addressing the Advanced Notice of Proposed Rulemaking for proposed changes to the Common Rule.  For those of you just catching up, it may be helpful to read the past posts.  I had the opportunity to interview John Stillman, Director of the Institutional Review Board for the University of Utah, to gain some insight on what the proposed changes mean.

Another major shift in the ANPRM seems to be creating more categories of research that would be exempt or excused from IRB oversight.  I asked John what he thought of this proposed change.  He was very straightforward that he didn’t like it.  It appears extremely problematic to excuse a broad swath of research that today is reviewed by IRB, subjecting it only to audits to determine if the research was done appropriately.  It seems obviously silly to try to develop a system where somebody comes to audit excused studies AFTER they’ve been conducted because what is to be done if you find rampart errors (or more likely, the data has simply been destroyed)?

John told me there certainly should be steps taken to reduce the burden for doing minimal risk research, but this proposal goes too far.  Perhaps a solution is to have exemptions approved by IRB with the understanding that the IRB can be reasonable, by approving minimal risk studies in a shorter period of time, for example.  John thinks it is better to harmonize and make clear to IRBs what is and is not minimal risk, so that they can better make efficient determinations, rather than bypass the IRB process altogether.

Thank you John for allowing me to interview you, and for the interesting insight you provided to the ANPRM for proposed changes to the Common Rule.  Remember, if you have anything to say about these proposed changes, the comment period closes on October 26, 2011.

– Kim Child