Monday, June 29, 2009

Finnish Group Warns Against Unnecessary Bureaucracy

Klaus Mäkelä and Kerstin Stenius kindly alerted me to their paper, "A New Finnish Proposal for Ethical Review in the Humanities and Social Sciences," which they presented in London in April. The paper describes a draft report by a working group of Finland's National Advisory Board on Research Ethics, which examined the need for ethics review in the humanities and social sciences.

In its draft report, issued in January, the working group adopted some principles that would be familiar to ethics committees and regulators in the United States and other countries. The report stresses the importance of voluntary participation, informed consent, the confidentiality of information, the avoidance of "undue risk and harm," and the need for special care when researching minors. It sees ethics review committees as part of a process to effect these goals.

On the other hand, the working group recognizes that too much oversight presents its own problems:

5. It is important to respect the autonomy and good sense of research subjects. In social research, participants usually are fully competent to assess the risks involved without outside expertise. Ethics committees should avoid paternalism.

8. Clear criteria should be formulated for what kinds of projects require ethical review, but it should be up to the researcher to determine whether a project meets these criteria.

10. The work of ethics committees should be as transparent and open as possible and a system of appeals should be put in place.

The second part of principle number 8 is particularly significant. U.S. regulators have, since 1995, insisted that researchers cannot be trusted to determine when their research is subject to review under the Common Rule. Recently, Jerry Menikoff of OHRP noted that institutions are not legally required to strip researchers of the power to make these determinations, but OHRP will continue to recommend that they do so.

The Finnish working group, by contrast, sees a greater danger in giving that power to committee members and staffers who will likely err on the side of too much review:

It is a matter of judgement to decide what kinds of stimuli are 'exceptionally strong'. To avoid unnecessary bureaucracy, it nevertheless should be up to individual researchers to decide whether their project falls into the categories listed above and needs to be submitted to ethical review. It is highly unlikely that this will lead to transgressions, and ex post facto sanctions will be enough to keep any exceptions under control.

In short, the working group understands that in this case, the dangers of too much bureaucracy outweigh the dangers of too little.

I should note that the London conference at which Mäkelä and Stenius presented their work was the Third Working Meeting of the International Study of Ethical Codes and Ethical Control in the Social Sciences, the previous conferences having been held in London in 2007 and 2008. The meetings have brought together scholars from several northern European countries to discuss social science ethics and regulations across international borders. It is splendid that these scholars are at work on so important a topic, and I look forward to learning more from them.

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.

Friday, June 5, 2009

Lisa Wynn's Words and Pictures

In April I commented on the ethics training program for ethnographers developed by Lisa Wynn of Macquarie University with some colleagues.

At Culture Matters, the blog of the Macquarie anthropology department, Wynn described the ideas that led her to develop the program.

Now, at Material World, a blog hosted by the the anthropology departments of University College London and New York University, Wynn describes another aspect of the training program: the pictures.

Wynn explains that along with its medical-centered ethics and jargon-laden text, the standard NIH ethics training program suffers from clip art in which people are depicted as faceless cartoons--probably not the best way to get researchers thinking about others as autonomous individuals. So for her program, Wynn offers pictures of real researchers and research participants, from Laud Humphreys to Afghan school administrators.

Gathering these photos--about a hundred in all--wasn't easy, but they contribute meaningfully to the warmth and depth of the site. And it put Wynn in touch with some prominent scholars.

[Side note: Professor John Stilgoe tells his students that it's rare to have enough photos of yourself at work. That's a good admonition; you never know when someone will want to show you doing controversial research.]

In another posting on Culture Matters, Wynn describes her continuing research on research ethics. She notes that ethics-committee oversight of ethnography is a relatively recent phenomenon. While it was debated as early as the mid-1960s, only in the 1990s did it become widespread. Thus, in studying the effect of ethics committees,

We’ve got a perfect “natural” control: an older generation of researchers who spent most of their careers not seeking ethics clearance, a younger generation for whom it is standard operating procedure, and a “middle-aged” group of researchers like myself who started their research under one regime and now live under another (I swear, this is the first time I’ve thought of myself as middle-aged). By correlating responses with different regulatory regimes, we can ask questions like: do researchers who never got ethics clearance have different ideas about what is ethical than researchers who go through ethics review? Does one group consider itself more or less ethical than the other? Or do they feel like ethics oversight hasn’t made any difference to their research practice?

Wynn plans to contact scholars in Australia and the United States to see how the spread of ethics review affected ideas about research ethics. I'm quite excited by this work; in fact, I plan to publish it in a special issue of the Journal of Policy History I am editing on the general topic of the history of human research ethics regulation.

How many pictures should I demand?