It’s IRB week over at The Hardest Science; Sanjay has an excellent series of posts (1, 2, 3) discussing some proposed federal rule changes to the way IRBs oversee research. The short of it is that the proposed changes are mostly good news for people who do minimal risk-type research with human subjects (i.e., stuff that doesn’t involve poking people with needles); if the changes pass as written, most of us will no longer have to file any documents with our IRBs before running our studies. We’ll just put in a short note saying we’ve determined that our studies are excused from review, and then we can start collecting data right away. It’ll work something like this*:
This doesn’t mean federal oversight of human subjects research will cease, of course. There will still be guidelines we all have to follow. But instead of making researchers jump through flaming hoops preemptively, enforcement will take place on an ad-hoc basis and via random audits. For the most part, the important decisions will be left to investigators rather than IRBs. For more details, see Sanjay’s excellent breakdown.
I also agree with Sanjay’s sentiment in his latest post that this is the right way to do things; researchers should police themselves, rather than employing an entire staff of people whose jobs it is to tell researchers how to safely and ethically do their research. In principle, the idea of having trained IRB analysts go over every study sounds nice; the problem is that it takes a very long time, generates a lot of extra work for everyone, and perhaps most problematically, sets up all sorts of perverse incentives. Namely, 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), and investigators have an incentive to off-load their conscience onto the IRB rather than actually having to think about the impact of their experiment on subjects. I catch myself doing this more often than I’d like, and I’m not really happy about it. (For instance, I recently found myself telling someone it was okay for them to present gruesome pictures to subjects “because the IRB doesn’t mind that”, and not because I thought the psychological impact was negligible. I gave myself twenty lashes for that one**.) I suspect that, aside from saving everyone a good deal of time and effort, placing the responsibility of doing research on researchers’ shoulders would actually lead them to give more, and not less, consideration to ethical issues.
Anyway, it remains to be seen whether the proposed rules actually pass in their current form. One of the interesting features of the situation is that IRBs may now perversely actually have an incentive to fight against these rules going into effect, since they’d almost certainly need to lay off staff if we move to a system where most studies are entirely excused from review. I don’t really think that this will be much of an issue, and on balance I’m sure university administrations recognize how much IRBs slow down research; but it still can’t hurt for those of us who do research with human subjects to stick our heads past the Department of Health and Human Service’s doors and affirm that excusing most non-invasive human subjects research from review is the right thing to do.
* I know, I know. I managed to go two whole years on this blog without a single lolcat appearance, and now I throw it all away for this. Sorry.
** With a feather duster.