My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.

NRC Report: Assess Risk Empirically

One theme running throughout the NRC report is the need to replace the worthless gut reactions decried by Ezekiel Emanuel with a system that would base its judgments on the latest empirical evidence. But the report does not present a clear set of reforms that would effect this change without scrapping the current system of local IRB review.

The Years Spin By

In his presentation to the Presidential Commission for the Study of Bioethical Issues today, Ezekiel Emanuel showed some textual slides that were visible during the live webcast but do not show up--at least on my browsers--when I replay the recording.

One of these slides featured a timeline of events leading to the current system of human subjects protections. That timeline featured two common errors.

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

ANPRM's Problem Statement: Helpful but Incomplete

One of the many remarkable sections of the July 26 advance notice of proposed rulemaking (ANPRM) is its admission that the Common Rule is flawed.

(Note: I have added a link to the ANPRM at the top of the link list in the sidebar.)

Since the 1970s, IRB apologists have claimed that federal regulations are flexible enough, and that local IRBs are to blame for any problems. In 2007, for example, Jerry Menikoff quoted with approval Jeffrey Cohen's 2006 claim that "the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations." Menikoff reiterated his claim of "flexibility within the system" in his 2009 speech, “The Legal Assault on the Common Rule."

After thirty years of such claims, it is wonderfully refreshing that the ANPRM takes so seriously many of the critiques leveled at the federal regulations themselves. And the ANPRM helpfully organizes those critiques into seven general categories.

On the other hand, ANPRM's problem statement (pages 44513-44514 in the Federal Register version) overlooks some major critiques. Fortunately, some of those critiques are implicitly recognized by some of the ANPRM's proposals.

Emanuel and Menikoff Explain the ANPRM

Ezekiel Emanuel, head of the Department of Bioethics at NIH, and Jerry Menikoff, director of OHRP, explain the ANPRM for readers of the New England Journal of Medicine.

[Ezekiel J. Emanuel and Jerry Menikoff, "Reforming the Regulations Governing Research with Human Subjects," New England Journal of Medicine, 25 July 2011. h/t Michelle Meyer]

The essay is a very helpful introduction to the ANPRM, clearer than the ANPRM itself. The authors conclude,

After 20 years, and the introduction of significant changes to the research landscape, many believe that the Common Rule needs revision. The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.

Fine, I'll say it. I agree with Jerry Menikoff.