Wednesday, June 17, 2009

Menikoff to Critics: "Yes, We Hear You"

Theresa Defino kindly alerted me to the streaming video feed of Dr. Jerry Menikoff’s May 14 address at the University of Michigan, “The Legal Assault on the Common Rule." The speech was an impressive acknowledgment of the widespread criticism of the foundations of the IRB system, and it ended with the promise of some substantive improvement. But by listing some of the most common critiques of the IRB system without attempting to rebut them, Menikoff fell short of the dialogue he seeks to foster.

Menikoff began his speech with a word for IRB critics: "Yes, we hear you." He then spent most of his hour summarizing some of the more prominent critiques of the U.S. IRB system. Among them:

(As Menikoff noted, challenges to the legality of the IRB regime are only one component of this broad critique, and Menikoff declined to go into detail about them. This makes the title of his speech an odd one.) For most of the speech, Menikoff was carefully respectful of the authors of these documents, noting their prominent positions and accomplishments in other areas of scholarship. The only real rebuttal he made was to suggest that some critics are too quick to assume that an IRB would demand to review, or even deny, a particular study. That's a good point; it's always better to critique the system with a real horror story about thwarted research, rather than a hypothetical one. What Menikoff didn't say is that there are plenty of real horror stories to go around. Menikoff offered one important concession. In his 2007 article, "Where’s the Law? Uncovering The Truth About IRBs and Censorship," he had suggested that if an institution required IRB review of research exempted by the Common Rule, researchers at that institution shouldn't blame the feds:
An institution can choose to impose rules that are more restrictive than [federal] regulations. But complaints about censorship resulting from such a circumstance would seem more appropriately directed at the specific institutions that are choosing to do this, rather than the IRB system itself, as created by the federal regulations. (792, n. 6)
Such analysis ignored the role of OPRR/OHRP in encouraging institutions to impose requirements beyond those in the regulations. In particular, in 1995, OPRR advised institutions "that investigators should not have the authority to make an independent determination that research involving human subjects is exempt." More recently, OHRP contributed to a 2008 report that recommended expedited review for several hypothetical projects that would seem to merit exemption. In his Michigan speech, Menikoff did better. He conceded that OHRP continues to recommend that researchers should not make exemption determinations. But he also noted, "it's just a recommendation. You don't have to follow it." He pledged that OHRP would clarify this. While this concession is welcome, it is pretty small stuff. Even on the narrow issue of the Common Rule exemptions, it ignores the question of why OHRP continues to promulgate guidance that contradicts the intent of the authors of the exemptions and that originally emerged from the panic of the mid-1990s that almost everyone agrees led to the overregulation of human subjects research. Nor can I put much faith in a promise that new guidance from OHRP is just around the corner. More importantly, it's frustrating that Menikoff missed the opportunity to address the central problem posed by the critics he cited: there is no evidence that the IRB system does more good than harm. The question of self-exemption is important, but in the context of the overall critique of the system outlined in the speech, Menikoff's emphasis on this one point becomes a bit of a red herring. Finally, I must object to Menikoff's patronizing remarks about the emotional state of IRB critics:
It's not as if everything or even the bulk of what these people are claiming is necessarily true or valid, but nonetheless we again have to be aware of the strength of their feelings and the source of it. There is this heartfelt feeling about at least parts of the human protection system that they are wrong.

Yes, critics are angry, but it is insulting to portray us as so overcome with emotion that we cannot form "true or valid" complaints. It is not the strength of our feelings that should concern Menikoff, but the accuracy of our facts and the logic of our arguments.


Anonymous said...

OHRP would also need to modify the terms of FWAs (or finally admit that FWAs are worthless- why does there need to be an additional promise to follow regulations by which an institution is already bound?). While the terms do not explicitly require review of exempt research, the terms could easily serve as the basis for OHRP to hold an institution accountable for an exempt project that was not sufficiently "guided" by the Belmont Report (emphasis added below)...


1. Human Subjects Research Must be Guided by Ethical Principles

All of the Institution’s human subjects research activities, regardless of whether the research is subject to federal regulations, will be guided by the ethical principles..."

Zachary M. Schrag said...

Thank you for your comment.

I fear I don't understand your claim that "FWAs are worthless." Many regulations require that persons or institutions sign promises to obey them. Drivers' licenses, tax returns, and building permits, for example, all serve this function.

And as you point out, FWAs serve an additional purpose: they allow OHRP regulators to extend their power beyond the scope of 45 CFR 46, by extracting additional promises. Regulators have been playing this game since 1981. See E. L. Pattullo, "How General an Assurance?," IRB: Ethics and Human Research 3 (May 1981): 8-9.