Tuesday, February 28, 2012

IRBs Misunderstand Researchers' Complaints

A study of IRB chairs, members, and staff finds that they understand that researchers regard them as powerful actors, "Yet IRBs may misperceive PI complaints."

[Robert Klitzman, "The Ethics Police?: IRBs’ Views Concerning Their Power," PLoS ONE 6 (2011): e28773. doi:10.1371/journal.pone.0028773. h/t Roberto Veloso]

Robert Klitzman, Associate Professor of Clinical Psychiatry at Columbia University, "conducted in-depth telephone interviews of 2 hours each with 46 [IRB] chairs, directors, administrators, and members" from 34 institutions, drawn from a list of the top 240 institutions by NIH funding. He took a Grounded Theory approach to identify "categories of recurrent themes and issues" among the interviews.

Klitzman's respondents did understand that researchers would not want a process that is biased against particular researchers, and that they care around turnaournd time. What they don't seem to understand is researchers' wish for what Malcolm Feeley and Jack Katz have called a "culture of legality." As Klitzman puts it:

IRBs appear to try to justify their power, arguing that it helps PIs and human subjects, though that claim may not be based on empirical evidence, and may actually cause harms that the IRB may not sufficiently acknowledge or weigh, delaying or impeding valuable research . . .

Much of IRB work occurs behind closed doors, which can aggravate these tensions. Minutes are not publicly accessible, but arguably attempts should be make these available, at least in part, to whatever degree may be reasonable and possible. IRBs keep minutes private, along with all correspondence and decisions (except to the PI involved). Yet increasing transparency could potentially help improve perceptions of IRBs among PIs. Given concerns about proprietary information, redaction of details at any institution may be hard for certain studies, particularly those that are industry-funded. Yet transparency may not be as difficult for many other, non-industry funded protocols. IRBs could, for instance, post examples, with details redacted, of the types of concerns they have had about issues that arise in various protocols. Such an approach could yield many benefits. Yet IRBs may themselves prefer the lack of transparency, as it may reduce questions about their processes and decisions – which presumably is not the intended goal of the current practice of non- transparency. These interviews thus highlight key questions of how much lack of transparency is, or should be permitted.

In particular, he notes the significance of a lack of an appeals process.

IRBs should realize that the absence of an appeals process gives them de facto considerable power. To ignore this fact can exacerbate tensions between IRBs and PIs, while increased acknowledgement of this perceived power can help IRBs facilitate interactions with PIs, and thus in the end best help protect human subjects.

Not only would an appeals process help researchers who feel wronged; it could also help IRBs that currently "cannot publicly respond if PIs vocally fault the committee within an institution." In a formal appeal, both sides could be heard. Indeed, a comment on the article recounts an instance in which a PI and IRB submitted their disagreement to an independent IRB, which found that the IRB's concerns were justified.

Klitzman also notes IRBs' feelings of powerlessness in the face of federal regulations and enforcement actions. As he puts it, "PIs may also unfairly 'blame the messenger,' resisting federal regulations, exacerbating conflicts. Researchers should realize that IRBs, while subjectively implementing these regulations, are in fact also constrained in many ways by these policies, and fears of governmental audits, and generally appear to be trying their best." This finding nicely challenges the old line that IRBs need only take advantage of the regulations' "flexibility." It's hard to be flexible with a cattle prod shoved into your back.

Klitzman cites several additional IRB articles he has in press; I will look forward to them.

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