Elliott Still Wants to Scrap IRBs

Writing in the New York Times about a series of scandals at the University of Minnesota, bioethicist Carl Elliott calls for the IRB system to be abandoned and replaced with “a full-blown regulatory system.” This is essentially the same argument he made in the New York Times in 2011, when the ANPRM was issued.

[Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.]

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.

A Credible Social Assurance

I am reading Alex John London's claims that IRBs help to "provide a 'credible social assurance' to the American people that social institutions, funded by their tax dollars and empowered to advance their health and well-being, work to: respect and affirm the moral equality of all community members; prevent the arbitrary exercise of social authority; and help create a 'market' in which the diverse stakeholders, often working to advance diverse ends, collaborate in a way that advances the common good."

I am reading Carl Elliott's accounts of the difficulties he has faced trying to use the IRB system at a public university to achieve any accountability for the burying of a drug study after it did not deliver the results a drug company wanted.

And I am re-reading Allan Brandt's Cigarette Century, which explains how tobacco companies reacted to early findings that cigarette smoking causes lung cancer. They promoted the use of filter tips, which didn't trap carcinogens but did turn brown as the cigarette burned. In 1966, Philip Morris executives noted that "the illusion of filtration is as important as the fact of filtration."

Armchairs vs. Evidence in the Journal of Law, Medicine & Ethics

Last week I promised some comments on the Winter 2012 issue of the Journal of Law, Medicine & Ethics, which features a symposium entitled "Research Ethics: Reexamining Key Concerns."

The contributions reinforced my sense that the IRB debate is in part a contest between evidence-based approaches and armchair ethics.

Elliott Decries IRB Opacity

Writing for the Chronicle of Higher Education's Brainstorm Blog, Carl Elliott argues that the "by any reasonable estimate [the IRB] oversight system has been a failure . . . yet so many people are professionally invested in the current oversight system that they cannot imagine replacing it, only tinkering with it." He particularly condemns the secrecy of the system.

[Carl Elliott, “When Medical Muckraking Fails” Chronicle of Higher Education, Brainstorm, August 2, 2012.]

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.

Elliott Wants to Scrap IRBs

Carl Elliott, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine, calls IRBs "incapable" and wants them replaced.

[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]