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March 29, 2008

Articles of Interest

Several articles of interest:

Regulatory Innovation in the Governance of Human Subjects Research: A Cautionary Tale and Some Modest Proposals

Scott Burris (Law - Temple)

Regulation & Governance, Vol. 2, No. 1, pp. 65-84, March 2008


Under U.S. regulations known as the Common Rule, federally-supported human-subject research must be reviewed by an Institutional Review Board (IRB). The Common Rule system looks from a distance like an innovative instantiation of prescriptions for constitutive regulation and soft law, but in practice has grown into a self-referential, unresponsive and legalistic bureaucracy. The paper reviews the criticism of the system and discusses why it fails to regulate in an efficient and effective way, pointing in particular to the poor fit between the IRB and its assigned tasks. Turning to reforms, the paper uses the heuristic of regulatory space to describe the range of actual and potential regulators with the capacity to set standard, monitor compliance and discipline violators in the realm of research. Three essential conceptual changes are set out to frame the technical regulatory reform discussion: facing up to the built-in limitations of the IRB as an oversight body; narrowing the range of risks the system is tasked to control; and disentangling the conflicting regulatory logics of behavioral standard-setting and virtue promotion. It concludes with a roster of possible changes that would make the IRB a more responsive regulator, enroll a wider range of actors in the promotion of ethical virtue, focus resources on more serious risks, and address the structural causes of researcher misconduct.

There was much I liked about this article, though I certainly did not agree with all of it.  I personally am quite sympathetic to calls for a more thorough overall of the system by which we assess the ethics of human participants research.  Though Burris obviously perceives the importance of such ethics, at times he veers close to rejecting the entire project because of his dissent with the ways in which the system has been analyzed and construcuted through traditionally dominant bioethics paradigms.

As I've noted before, dissatisfaction with traditionally prevailing modes of bioethics -- in which I enthusiastically share --  hardly diminishes the importance of Plato and Aristotle's questions as applied to research: what is the good? How shall we live?

Still, Burris's take and recommendations are original, and there is no doubt such novel thinking is needed in thinking about the regulation and ethics of research.

Thinking Historically About Public Health

Alison Bashford (Univ. Sydney - History); Carolyn Strange (Australian National University)


This paper argues that analysing past public health policies calls for scholarship that integrates insights not just from medical history but from a broad range of historical fields. Recent studies of historic infectious disease management make this evident: they confirm that prior practices inhere in current perceptions and policies, which, like their antecedents, unfold amidst shifting amalgams of politics, culture, law and economics. Thus, explaining public health policy of the past purely in medical or epidemiological terms ignores evidence that it was rarely, if ever, designed solely on medical grounds at the time.

From the text:

Whether or not they make explicit links to the present, historically minded studies of public health confirm that past practices inhere in current perceptions and policies, which, like their antecedents, unfold amidst shifting amalgams of politics, culture, law and economics. in addition to increasingly sophisticated medical expertise.

[ . . . ]

Thus, for example, the immediate response to SARS-infected individuals and suspects SARS "hotspots" in Asian and Canada in 2003 was fundamentally the same as the European response to cholera in 1831; surveillance, isolation, quarantine, border control.

This is a simply brilliant article, one of the best I've ever read in expressly detailing the importance of history for contemporary public health policy.  Highly recommended.


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