Wednesday, February 28, 2007

Schwetz Promises New Guidelines (New York Times)

Today's New York Times features a front-page story on IRBs by reporter Patricia Cohen: "As Ethics Panels Expand Grip, No Field Is Off Limits."

Included in the story is some potentially very important news:

Bernard A. Schwetz, director of the federal Office for Human Research Protections, which administers the regulations, acknowledges that the guidelines covering the boards’ actions have not been clear enough and says he intends to make public new proposed guidelines before the end of the year.

Unless I am mistaken, these will be the first new guidelines since the broadening of categories for expedited review in 1998. Researchers should not miss this once-in-a-decade opportunity for action.

Wednesday, February 21, 2007

The Australian

John Mueller kindly alerted me to an essay from Australia: Greg Bamber and Jennifer Sappey, "Consenting Adults and the Path to Truth," The Australian, 21 February 2007.

Bamber and Sappey study management, and their most detailed complaint about human research ethics committees (HRECs, the Australian for IRBs) concerns workplace case studies. They note that such studies

may challenge a unitary view of the workplace as essentially harmonious, which chief executives and their spin doctors seek to promote. This challenge is significant because it seems likely that under the new statement many HRECs will continue with their practice of requiring a researcher to obtain written consent from a chief executive or the equivalent before beginning a case study. A condition of granting consent may be the opportunity to veto output.

How well does this correlate with the university principle that research is the pursuit of truth? In the case of workplace studies, it is reasonable to ask: whose truth - that of the chief executive, other managers, workers or customers? Chief executives' denial of access or their selective filtering of the information provided could deny the work force's (or customers') right to have their truth told.

Unfortunately, having asserted the duty of the researcher to pursue truth, Bamber and Sappey step back to a meeker position:

In view of their health-research paradigm, there is a tendency for HRECs to err on the side of being risk-averse, overstating the importance of consent and of the welfare and privacy of participants, while giving too little weight to the benefits of research to society. In social science research the risks are invariably much lower than in health research.

That last sentence is unworthy of the rest of the essay. How can a study that challenges the power structure of a workplace be less risky than collecting undergraduates' spit? If Bamber and Sappey believe, as I do, that some researchers have the duty to pursue truth and justice, even if that means that a business executive is jailed for corruption or fraud, they should come out and say so. Let's not hide behind the idea that social science research doesn't hurt.

Sunday, February 11, 2007

In Search of Expertise

When, in the 1960s, the federal government began requiring ethical review of proposals seeking funding for medical experiments, regulators expected that the review would be conducted by experts in the field. Thus, the U.S. Public Health Service's PPO #129, "Clinical Investigations Using Human Subjects" (8 February 1966), required "prior review of the judgment of the principal investigator or program director by a committee of his institutional associates," presumably other doctors or biomedical researchers. The 1974 version of 45 CFR 46 [PDF] required that each IRB be composed of "not less than five persons with varying backgrounds to assure complete and adequate review of activities commonly conducted by the organization. The committee must be sufficiently qualified through the maturity, experience, and expertise of its members and diversity of its membership to insure respect for its advice and counsel for safeguarding the rights and welfare of human subjects."

In response to concerns that researchers could not be trusted to watch other researchers, in 1981 the Department of Health and Human Services added the requirement that "each IRB shall include at least one member whose primary concerns are in nonscientific areas; for example: lawyers, ethicists, members of the clergy." [PDF] The language of the provision shows that the department did not imagine applying these rules to nonscientific researchers (such as lawyers, ethicists, or members of the clergy), but that's not the point here. The point is that the regulations' drafters expected IRBs to be dominated by experts "possessing the professional competence necessary to review specific research activities," with one or two lay members added to represent the conscience of the community.

Recently, some have called for a greater role for non-expert members. In 2001, for example, the National Bioethics Advisory Commission recommended that "members who represent the perspectives of participants, members who are unaffiliated with the institution, and members whose primary concerns are in nonscientific areas . . . should collectively represent at least 25 percent of the Institutional Review Board membership," rather than the single member now required.

But a bigger problem may be not a lack of lay representation, but a lack of expertise.