Conflict of Interest Guidelines - 1/2 a Loaf

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Interesting story from UPI today about an effort by three universities - Johns Hopkins, Duke and Wake Forest - to draft conflict of interest guidelines for doctors running clinical trials.

“There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it,” says lead investigator Jeremy Sugarman, a professor of bioethics and medicine at the Johns Hopkins Berman Institute of Bioethics.

He’s right, but the proposed language doesn’t go far enough. This is what it says:

“The person leading this medical research study might benefit financially from this study. The Institutional Review Board and a committee at ABC University have reviewed the possibility of a financial benefit. They believe that the possible financial benefit to the person leading the research is not likely to affect your safety and/or the scientific quality of the study. If you would like more information, please ask the researchers or the study coordinator.”

If an IRB or committee is so confident about its judgement, it should also be confident enough to require full disclosure, or at least more information about the perceived conflict. It’s a good idea to encourage questions, but this language runs the risk of brushing past any problem.

Anyone have any better ideas?
[tags]Conflicts of Interest[/tags]

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