Jeremy Sugarman: Research Ethics Costs Money
Jeremy Sugarman keeps doing the research everybody else wishes they had thought to do. In the April 28th New England Journal of Medicine, Sugarman and others examined data from a number of major medical centers to assess the cost of IRBs. The operating costs "ranged from $171,014 to $4,705,333, with a median cost of $741,920," and that means that "institutions and policy-makers need to recognize the important role of the IRBs in protecting research participants so that they are not shortchanged." More important, the bigger the place, the cheaper the review - $400 for high-volume medical centers versus $600 for low volume spots.What Sugarman doesn't say but is interesting nonetheless is that the median cost of $742K/yr for an IRB is about double the median support level for a bioethics program in an academic medical center. Lots of bioethics folks who are struggling for cash might want to consider annexing their IRB...
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An open question remains. For all the dollars expended by IRB's do they in fact protect human subjects? I think the answer depends on how much we believe that mega-paper review leads to genuine protection. It is just as plausibel to believe that the forest is lost through the trees with this type of process
- by mbfoglia on May 17, 2005 at 3:11 PM | link
At this point, there is no way to tell.
You could of course run a trial, and say that research done in 25 states of the union would not undergo regulatory review, while the rest did, and then compare the results after a couple of years.
But no IRB would approve such a trial. Regulation of research is now the 'standard of (ethical) care', even if its efficacy is no longer able to be proved ...
- by Sam I am on May 17, 2005 at 11:42 PM | link
well ok but the no brainer here is that rich hospitals are at a ridiculous advantage in terms of the cost per trial of IRB review.
- by Jeremy on May 18, 2005 at 1:25 AM | link