“If it ain’t broke, don’t fix it,” that’s how the old saying goes. That’s not what what Kenneth Getz says about our current state of US human protection IRB system. Getz’ article published in Applied Clinical Trials Online titled “Frustration with IRB Bureaucracy & Despotism,” speaks upon his own and others’ disappointment for the direction IRBs have taken. At the core of Getz’ argument lies in one main plea: our current human subject protection system is ripe for radical reform. Getz states that one main problem with the current system is that IRBs are burdened with “substantial inconsistencies in ethics regulations” by the number of agencies that control them (i.e. the FDA, OHRP, the policies of the hospital, the requirements of their university). Because of this, IRBs face the challenge of “complying with many different and potentially conflicting requirements” from several different organizations. Just as a child may act out if given inconsistent or unclear directions, a board of professionals trying to meet differing regulations from a number of agencies are bound to make mistakes or behave unexpectedly.
Currently, all institutions and investigative sites involved in research must receive IRB approval, which may result in a waste of time and money because a single protocol may be reviewed several times with contrasting outcomes from different IRBs. Getz wrote his article in response to such a situation: a general educational brochure prepared by the Center for Information and Study on Clinical Research Participation (CISCRP) was reviewed by 12 IRBs, 11 of which suggested changes to the brochure and one rejected it altogether. Examples such as this have brought people to question the jurisdiction and authority the current national IRB system, but such concerns should be seen as a step toward refining the system toward achieving its original purpose. Of course, we see part of the solution as rooted in central IRB reviews with strong delegation of authority and communication between the central IRB and research institution and sites. As the October 2010 NEJM article, “The Paradoxical Problem with Multiple-IRB Review,” from the head of the OHRP (Jerry Menikoff) shows, central IRBs are seen as a move in the right direction due to more central oversight of safety signals, increased efficiency, and more central point of accountability.
Check out Kenneth Getz’ full article here.
To see an excerpt from Menikoff’s article, click here.