Saturday, January 31, 2009

And the Bush Was Not Consumed

Robert Dingwall kindly alerted me to Scott Kim, Peter Ubel, and Raymond De Vries, "Pruning the Regulatory Tree," Nature 457 (29 January 2009), 534-535.

The authors have complex disciplinary backgrounds. Kim has an MD and a PhD in philosophy, and teaches psychiatry. De Vries has a PhD in sociology and the title of associate professor of bioethics/medical education. And Ubel has an MD and describes himself as a "physician and behavioral scientist." Together, they are unusually well prepared to think about the full range of disciplines affected by human subjects regulations.

The authors complain that IRB review of minimal risk research wastes time and money, infringes academic freedom, and threatens public health by impeding important research. They conclude that "it is unethical to support a system that creates a significant financial, scientific, clinical and ethical burden with virtually no counterbalancing good."

To fix this, they propose "a simple regulatory change that is far-reaching, equitable and yet low risk: exempt minimal-risk research from IRB review." In their scheme, researchers would still "complete a brief application describing research procedures, risks, burdens and the potential loss of otherwise expected benefits to the subjects. An institution-designated person reviews the application, and exempted protocols would not be subject to further IRB review. The application becomes the project's registration and serves as an accountability document."

This sounds fine on the surface, but the proposal raises some questions.

1. How can we change the Common Rule?

The authors propose a change in the regulations, but they do not address the difficulty of getting agreement from all Common Rule signatories. In 2002, Marjorie Speers of AAHRPP testified that " there is no effective means to [revise policy]; the agencies who are signatories to the Common Rule have not been able to make changes to it in the last 11 years even though the need for changes has existed." That was nearly seven years ago, and nothing has improved. See The Calcified Common Rule.

Under the circumstances, we may need new legislation, rather than regulation.

2. Would OHRP and institutions respond to changed regulations?

The authors recognize that even if the regulations were changed, "institutions have a tendency to impose on themselves requirements that are even more stringent than those required by law," so they might impose review on minimal-risk research anyway. Indeed, the 1998 Bell study found that less than half of protocols eligible for exemption actually received it. I imagine that percentage has gone down in the past decade, considering regulators' hostility to the existing exemptions.

To address this problem, the authors claim that "a new regulation that exempts minimal-risk research from IRB review would send a clear and unambiguous message that the government's priority is not on intense oversight of low-risk research." Perhaps, but the government does not speak with one voice, and regulators have resisted earlier calls for deregulation. The greatest effort at deregulation--the 1981 exemptions--was followed within months by OPRR suggestions that universities act more stringently than required by the regulations. The 1995 ACHRE recommendation for "alternative mechanisms for review and approval of minimal-risk studies" was followed by the OPRR crackdown that led to far more burdensome review of minimal risk research.

If the authors are serious about reform, they should seek not a "message," but rather a law that restrains OHRP and penalizes interference with minimal risk research.

3. Would exemption be any better than expedited review?

As noted above, when the authors call for "exemption," they use the term in the specialized way introduced by OPRR in 1995. Rather than meaning that a researcher is free from IRB jurisdiction, they mean that a researcher would still have to write up an application and submit it to an "institution-designated person." The authors claim that "substantial resources would be freed for better uses."

The authors base this claim in part on a 2005 finding that in US medical schools, the average expedited review cost more than the average full review ($1,060 vs. $1,021). [See Jeremy Sugarman, Kenneth Getz, Jeanne L. Speckman, Margaret M. Byrne, Jason Gerson, and Ezekiel J. Emanuel, "The Cost of Institutional Review Boards in Academic Medical Centers," New England Journal of Medicine 352 (April 28, 2005), 1825-1827.] But that study did not estimate the cost of reviews for exemptions.

Indeed, the system the authors propose is not very different from the current system for expedited review; the big difference being that the authors would delegate authority to an "institution-designated person" who might not be an IRB member. But their proposal would still require a good deal of paperwork and staff time, as well as the review by a single person, so it might not cost much less than the expedited system they seek to replace.

This question is open to empirical research. The authors, or someone else, could repeat the Sugarman analysis, but studying institutions that require staff review for proposals that are exempt under the existing 45 CFR 46.101 clauses.

4. Is pruning enough?

In sum, the regulatory tree may be tougher to prune, and to keep pruned, than the authors suppose. Here's a counter proposal adapted from advice concerning a similar growth:

For successful long term control of human subjects regulations, the extensive root system must be destroyed. Any remaining root crowns can lead to reinfestation of an area. Mechanical methods involve cutting vines just above ground level and destroying all cut material. Close mowing every month for two growing seasons or repeated cultivation may be effective. Cut human subjects regulations can be fed to livestock, burned or enclosed in plastic bags and sent to a landfill.

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