Tuesday, October 20, 2009

Misunderstanding what "exempt" means

One of the more absurd parts of the current way universities approach ethics review of research is the concept of "exempt". Many projects are categorically considered "exempt" from review because they are so obviously not a risk to humans that there is no need for review. For example, if all you are doing is taking a survey, your research is exempt. If all you do is examine test results in a classroom and draw inferences, your research is exempt.

Nonetheless, it's recommended that universities require review even for research that is exempt from review (emphasis mine):
The regulations do not specify who at an institution may determine that research is exempt under 45 CFR 46.101(b). However, OHRP recommends that, because of the potential for conflict of interest, investigators not be given the authority to make an independent determination that human subjects research is exempt.

This is extraordinary paranoia if taken literally. The non-exempt categories are bad enough. The exempt categories are easy to understand and have even more minimal risks. It's not like someone is going to misjudge whether their project is just giving out surveys when in fact it also involves injecting drugs into the students.

Further, some amount of personal judgment is an unavoidable part of any system of law or regulation. Even if every project is reviewed, who is to interpret the conclusions of the review rulings? Either the researcher has to interpret the rulings, or they need someone to make a further ruling on how to interpret the rulings. Assuming research actually happens, this recursion must cease and the researcher must eventually follow through with turning on a light switch or tying their shoes without directly getting review.

Additionally, how many researchers really comply? For example, looking at test results to draw conclusions about your students is exempt, which therefore means you are supposed to get it reviewed by your IRB. How many people really do this, though? In practice, requiring review of exempt research turns it even more into a system of selection enforcement -- a system that will essentially favor the higher-clout researchers over the lower-clout ones.

The saddest part of all this to me is that there is no one standing up for the advancement of knowledge. The higher-clout researchers have no problems with the extra regulations because they can just ask the reviewers to pass them. This makes it thus a benefit to them, because they can leave competing researchers to be tangled in the cobwebs. Where, in all of this, is anyone that is interested in real learning? I don't see it, and I'm not even sure where would be a good place to start. The inmates are running the asylum.

HT the Institutional Review Blog

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