Who's on YOUR IRB?

A recent article complied by the FogMag science news aggregator reported that a significant number of academic institutions do not have clear policies regarding conflicts of interest of members on their Institutional Review Boards (IRBs). All academic institutions are required to formally assemble IRBs to approve and regulate the ethical research practices of individuals and groups associated with the institution.
A conflict of interest would occur if a member of an IRB was involved in the evaluation of a research proposal that she had personal investments in that could affect her unbiased review of the proposal, for example, if a professor on an IRB reviewed a proposal presented by one of her grad students.

Having served on my college's IRB last year, I can say from my experience it seems that some IRBs don't have clear policies about ANYTHING. In 2007-2008, every proposal that passed through our IRB received "expedited" status, meaning it was cleared for approval by the head of the IRB without the entire committee ever assembling to give proposals "full" review. When I joined in 2008, the college had not provided any decent resources to train new IRB members about the federal laws, operational guidelines, and minute-taking procedures necessary in all IRBs. Members spent more time scrutinizing the grammatical errors in proposals than evaluating the potential risk to human research participants. It took us half the year to streamline the process of reviewing proposals, cataloging them, and checking the appropriate areas of the proposal to look at carefully. We had mastered the bare-minimum requirements for reviewing research proposals without dwelling on the more complicated issues of conflict of interest (aside from times when my own research was being reviewed and I needed to step out of the room, although I cannot say the same for other members' honesty regarding the review of their own proposals).

Serving on the IRB was as educational as it was frustrating. Not only did I learn what it might be like behind the scenes when other controversial research is being reviewed, I learned what it's like to work with a team of highly educated (all Ph.Ds) professional adults. Frankly, it isn't much different than working with teenagers when I served as president of my Associated Student Body in High School!

If my experience on the IRB is any indication of the way IRBs are handled at other institutions, we are in serious need of a national overhaul of IRB policy. Ethical review needs to be seen as more than a chore; some research, no matter how small or littered with misspellings in its proposal, raises serious ethical questions. In my time on the IRB, we never went through any process of discussing ethics themselves. Instead, it was up to each member to raise an issue with a specific proposal and support it on a case by case basis, rather than abiding by some established moral doctrine. It's no surprise, then, that the Massachusetts General Hospital's survey of 107 hospital and med school IRBs found that only 1 had a requirement that voting members must disclose industrial conflicts of interest (eg. being an investor in a medical device company seeking IRB approval to conduct research on a new device).

I recommend that IRBs become mandated to hold at least 1 public conference each year and 1 internal discussion about ethics each semester. Institutions have the obligation to create consistent doctrines about research ethics in the same way they create consistent doctrines about cheating. Each institution has the right to establish their own moral code in accordance with federal, state, and local laws. Of course, it is up to more than just the members of the committee to establish these policies, which is why public dialogue and IRB transparency is crucial to developing good research ethics policy. In addition, institutions ought to offer reasonable incentives to members on the board to go through more than minimal effort. Offering a million dollars to serve on an IRB would be unethical and create dangerous conflicts of interest, but there are certainly ways that institutions can make working on an IRB a more manageable commitment.

Published on June 22, 2009 in Science

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