Tuesday, February 12, 2008

What good are we? (and by "we", I mean IRBs)

Perhaps the most sweeping, bitter criticism comes from those who say IRBs are worthless and/or pointless. We are just a bunch of bureaucrats with nothing better to do except legitimize our existence by unrolling more red tape. A form of this criticism comes from the author of Scientific Misconduct Blog. (I am taking a bit of a liberty putting harsher words in his mouth but I wanted to reference his page in this post with a little emotion and this seems just as good as a way as any.) Although it was a short email, I think I understand his point. IRBs just don't cut it like they, perhaps, at one time did.

There are times I question whether the process itself is meaningful. In the end, I come to the definitive--and I mean definitive--conclusion that IRBs are important and necessary even if their responsibilities weren't codified in law.

However, I do believe IRBs are losing their way a bit. And I hope to be part of a movement that puts them on track and adapts to the modern times of research, compliance, and human subjects protections.

Specifically, this renaissance of human subjects protections begins with the acceptance that researchers are motivated by good and are well intentioned. Once that is agreed upon, the IRB's next goal is to promote and take active roles in ensuring the proposed and approved protocols are conducted ethically. This takes major form in Post Approval Monitoring. Most IRB's lack a strong PAM program. PAM is a terrific opportunity to ensure the research is being carried out as intended, study procedures are being followed, subjects are in fact being consented, and so on. I feel so strongly about this responsibility that I believe half of the resources of an IRB should be dedicated to this endeavor. It is that important.

I have little doubt this will be a common discussion item on this blog. But let's start here.

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