Wednesday, August 31, 2011

Does the ANPRM's Appeals Provision Address IRB Incompetence?

A correspondent suggests that the ANPRM fails to address the problem of incompetent IRBs, such as IRBs that lack the expertise necessary to do their work or otherwise fail to meet all the requirements of the existing Common Rule. I am inclined to disagree.

First, though the ANPRM's problem statement is too diplomatic to state that IRBs are doing a poor job, the ANPRM cites some scholarship reporting serious flaws in the system.

One striking example is the three citations to Lee A. Green, Julie C. Lowery, Christine P. Kowalski, and Leon Wyszewianski, "Impact of Institutional Review Board Practice Variation on Observational Health Services Research," Health Services Research 41 (February 2006): 214–230. Apparently frustrated by the 4,680 hours of staff time it took to win IRB approval for a multisite study of physician practices, the researchers decided to study their own notes to figure out what had sucked up the equivalent of more than two years of work. They found all sorts of IRB-generated problems and concluded that "several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects." Just by citing such studies, the ANPRM recognizes IRB fallibility to a greater degree than other official documents I've seen.

Second, the ANPRM's questions 27 through 29 at least raise the possibility that IRBs are making serious errors. Question 27 asks if IRBs remember that they "should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among the research risks that fall within the purview of its responsibility." In other words, it acknowledges that IRBs may frequently overlook some of the protections for research built into the regulations.

Question 29 asks if IRBs that act in ways not specified by the regulations be required to say that they are doing so "in furtherance of increased transparency." Here again, the implication is that IRBs are acting in ways not intended by the framers of the regulation, and either failing to notice that they are doing so, or not bothering to explain their actions.

Most dramatically, Question 28 raises the possibility of a mandatory appeal mechanism. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research specifically rejected such a provision, arguing that "an IRB should have the final word at its institution regarding the ethical acceptability of proposed research involving human subjects." Though the Commission had heard accounts of what Robert Levine later called "remarkably stupid behavior by IRBs," (PRIM&R Through the Years, 32), its members ultimately decided that maintaining IRB authority was more important than protecting researcher rights. Since then, groups like the AAUP have pointed to the "unchecked power granted to IRBs" as a contributor to IRB malfunction.

I would like to suggest, then, that the ANPRM contains a more radical critique of the IRB system than one would get from reading its problem statement alone. I encourage those who want significant change to answer Question 28 and call for an appeal mechanism as an important step toward addressing IRB incompetence.

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