Friday, August 5, 2011

Proposed changes to IRBs

Institutional review boards (IRBs) are committees formed within universities and research organizations. Their job is to review proposed research that uses human subjects, evaluating it for ethical treatment of the human participants. It's an important job given the rather spotty history we have with ethical research (see here, here and here among others).

However, there is a wide range of activities that count as human subjects research, ranging from experimental vaccine trials to personality tests, from political opinions to tests of color vision. Currently, all of this research is broken up into two groups: "regular" human subjects research, which is subject to a full review process and "minimal risk" research, which is subject to a faster review process. Research is defined as minimal risk when it poses no more potential for physical or psychological harm than any other activity in daily life.

My research falls into the minimal risk category. My experiments have been described by several subjects as being "like the world's most boring video game". Outside of being boring, they are not physically harmful, and there is no exposure of deep psychological secrets either. No matter. Each year, researchers like me fill out extensive protocols detailing the types of experiments they propose to do, detailing all possible risks, outlining how subject confidentiality will be maintained, etc. And each participant in a study (each time s/he participates) receives a 3-4 page legal document explaining all of the risks and benefits of the research, which the subject signs to give his consent.

This does seem to be overkill for research which really doesn't pose any sort of physical or psychological threat to participants, and I applaud new efforts to modernize and streamline this process. (Read here for a great summary of the details. Researchers: you can comment until the end of September, the Department of Health and Human Services is soliciting opinions on a bunch of things).

Among the changes are moving minimal risk research from expedited review to no review, and eliminating the need for physical consent forms (a verbal "is this OK with you?" will suffice). These are both good things that would improve my life substantially. However, I believe that standardizing IRB policies across the country would do the most good.

I am currently at my 4th institution and have seen as many IRBs. Two of them have been entirely reasonable, requiring the minimal amount of paperwork and approving minimal risk research across the board. The other two, however, have been less helpful. As Tal Yarkoni points out, "IRB analysts have an incentive to be pedantic (since they rarely lose their jobs if they ask for too much detail, but could be liable if they give too much leeway and something bad happens)". However, I think it goes beyond this. In some sense, IRBs feel they are productive by showing that they have stopped or delayed some proportion of the research that crosses their desks.

I have had an IRB reject my protocol because they didn't like my margin size, didn't like my font size, and didn't like the cute cartoon I put on my recruitment posters (apparently cartoons are coercive). I've had an IRB send an electrician into the lab with a volt meter to make sure my computer monitor wouldn't electrocute anyone. My last institution did not approve an experiment that was a cornerstone of my fellowship proposal as it required data to be gathered online (this is very common in my field) and I couldn't guarantee that someone outside of my approved age range (18-50) was doing my experiment. Under the current rules, I couldn't just use my collaborator's IRB approval as all institutions need to approve a protocol. However, another of the proposed changes will require only one approval.

I'm very optimistic about these proposed changes... let's hope they happen!

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