'Overkill' by IRBs

The APS workshop on IRBs [Observer, August 2003] admirably tried to deal with the complex regulatory web that has developed, ostensibly to protect human subjects. We have noted before that there seems to be no evidence that any of this is effective in that respect, but there is another concern here.

The regulatory representative, George Pospisil, notes "The Common Rule provides sufficient flexibility for IRBs to efficiently and effectively review non-biomedical research." In particular, Pospisil cites the provisions in the rule for exempted research, expedited review, and waiver of consent or waiver of documentation of consent.

This sounds reasonable, yet Pospisil then notes 1) "If you're reaching for the floor, you're not gonna make it" ("reach for the ceiling"), and 2) "expedited review does not mean review lite." The take-home message for local IRBs thus seems to contradict the alleged flexibility, being instead something more like "Don't dare miss anything!" as opposed to "Exercise good judgment." Contradictory conclusions may or may not be bothersome in a regulatory sense, but researchers definitely find them untenable.

The concept of "everyday risk" receives due mention as well, but with the caution: "Risk can range from simple embarrassment, to some serious risks, such as emotional distress, psychological trauma, invasion of privacy, loss of social status." The implication here also seems clear: go for "zero risk." Whether zero risk is a floor or a ceiling is not clear, but utopia is definitely a hypothetical, even fictional, condition.

The regulations may seem clear to those who spend full-time in the bioethics industry, but in fact the interpretations are as varied as some aspects of the Constitution. Given mixed messages, it is not difficult to see why local IRBs prefer to engage in overkill rather than to exercise flexibility.