Friday, April 27, 2012

Li Abandons Suit, But Brown University Still Ponders IRB Reform

Though it no longer faces a faculty lawsuit, Brown University is considering an outside review of its troubled IRB.

As readers of this blog may remember, Brown faculty have been complaining about the IRB since 2007, if not before.

In 2011, a Brown professor, Jin Li, took the highly unusual step of suing the university because of IRB interference in her work. In March, Li abandoned that effort, her attorneys agreeing to a dismissal with prejudice.

According to the Daily Herald, Brown faculty and administrators are discussing possible reforms, including an external review, broader disciplinary representation on the IRB, the creation of an additional IRB for non-biomedical human subject research, and "changing the charge of the IRB to make it not only a monitory board but also one that provides a more supportive and guiding role to research teams."

[Aparaajit Sriram, "IRB Likely to Undergo Review," Brown Daily Herald, 26 April 2012.]

The article does not mention the possibility of an appeals process, the lack of which was one of Li's complaints.

Thursday, April 26, 2012

Beauchamp and Saghai on the Mystery of Generalizable Knowledge

Philosophers Tom L. Beauchamp and Yashar Saghai find that although never defined, "the criterion of generalizable knowledge . . . is the foundation stone of the [National] Commission's conceptual and moral scheme in Belmont and beyond.

[Tom Beauchamp and Yashar Saghai. "The Historical Foundations of the Research-Practice Distinction in Bioethics," Theoretical Medicine and Bioethics 33, no. 1 (2012): 45–56. DOI 10.1007/s11017-011-9207-8. h/t Nathan Emmerich.]

Tuesday, April 24, 2012

Reverby Reviews Ethical Imperialism

Writing in the April American Historical Review, Susan Reverby very kindly reviews Ethical Imperialism:
Schrag is not alone in his critiques of the IRB process, but this is the first historical account of the problems IRBs pose to the social sciences. Officials in the federal government are currently considering revisions to the decades‐old Common Rule; Schrag's work has already begun to have an impact on their thinking, as evidenced by footnotes to his scholarship in their most recent report. This book ought to be required reading for those concerned about the political forces that make our work possible, and sometimes not possible at all.
[Susan M. Reverby, Review of Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009, American Historical Review 117, No. 2 (April 2012), pp. 484-485, DOI: 10.1086/ahr.117.2.484a,]

Thursday, April 12, 2012

An End to IRBs?

Ethics review is a big industry. As Will van den Hoonaard has noted,

In Canada alone, the business of academic ethics is a $35 million industry; when you include three other countries (United States, United Kingdom, and Australia), the industry amounts to some $500 million, with an inordinate amount of costs borne by cash-strapped universities. The reciprocal obligations, contradictions, and inherent permutations of such a large industry are nearly impossible to escape.

It may be hard to imagine such an industry disappearing overnight.

AAHRPP Organizations Check Fewer Boxes

The AAHRPP has reported that only 29 percent of its accredited organizations (not counting VA facilities, which don't have the option to uncheck boxes) pledged to apply all parts of the Common Rule to research not directly sponsored by the federal government. However, 72 percent of organizations that left at least one box unchecked still "applied the DHHS regulations to all research regardless of funding source." Thus, for a great many organizations, unchecking a box or two remains a way to escape federal oversight without offering researchers any additional freedom.

Friday, April 6, 2012

Could Retrospective Review End Nitpicking?

Robert Klitzman and Paul Appelbaum, both of Columbia University, suggest that shifting research oversight to the retrospective review of a subset of projects, rather than prospective review of proposals, could reduce the "variability and subjectivity across IRBs" that now characterizes ethics review.

[Robert Klitzman and Paul S. Appelbaum, "To Protect Human Subjects, Review What Was Done, Not Proposed," Science 335 no. 6076 (30 March 2012): 1576-1577,
DOI: 10.1126/science.1217225.]