Wednesday, March 30, 2005

IRB Overdrive: Raagh!

Lately, I’ve been somewhat irked by the actions of many IRBs that result in limiting research under the guise of protecting human subjects. I find many of these actions to be based on an overly paternalistic role –meaning that the IRB’s are making decisions to protect the subjects on such a level that they appear to be thinking for the subjects. I don't mean vulnerable populations either...

How does this shift take place? Is there a shift, or are IRB's liability aversive (answer=yes) and that aversion clouds their judgement (answer=maybe)? Responding to the first question, I believe that during the course of reviewing research and going through the decision procedure for protecting human subjects (as laid out in the regulations: OHRP or FDA and a slew of guidance documents, IRB's are on the face of it concerned with protecting human subjects. However, when the research appears to make use of some atypical and novel approach, or involves subject populations that at first impression appear to be not within the stereotypical view of normal (e.g., sexual fetish communities), some IRB's switch over to include institutional liability in their review assessment. Such liabilities may include both legal and PR aspects. There are several problems that arise when this occurs:

1) Loss of subjects' liberty:
The problem with any IRB acting in such a way is of course that it limits the autonomy of subjects who are peferctly able to make determinations on their own regarding the risk/benefit ratio of the research. Of course, I'm assuming throughout that informed consent was provided, was comprehensive, and was free of coercion. Nothing in the regulations suggests this super-paternalism, if anything, it is contrary to the purpose and the ethical postulates that underly the regs. The principle of volunti non fit injuria (<--this will bring up a google search) reflecting pro and con arguments for it] is applicable here when combined with the comprehensive informed consent requirements layed out in the applicable regulations.
By combining these two principles, the subject should be fully informed of the procedures, etc. of the research and is able to form a representative risk/benefit ratio of possible outcomes of participating in the research. As such, the choice to affirm or decline to participate and experience the resultant benefits/risks are theirs to bear. This was similar to HIV afflicted individuals making a push to being able to determine for themselves whether they wish to participate in experimental (read as unproven) drug trials.

2) Stigmatization of the IRB:
Other problems that may arise out IRB's acting under such a guise are that 1) researchers are likely to see that such liability factors were made during the review process and they're likely to believe that those decisions are not within the purview of the IRB, and 2) such actons are likely to stigmatize the IRB as some overbearing/beuoracractic body making caprcicious decisions...I'm not saying these perspectives are right, but I've seen at a couple of institutions and they stemmed for the IRB making such decisions (this shouldn't be anything new to those familiar with IRBs). There should be, and probably are, other bodies/departments in institutions that should consider this, and if necessary disapprove research, that may have some PR liability for the institution. Doing so would keep the role of the IRB alligned to its purpose, and portray the IRB to researchers as a body concerned with the protection of human subjects alone.


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June 07, 2007 8:09 AM  

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