Wednesday, June 3, 2015

Schneider: IRB System Is A Model of How to Regulate Badly

In an interview about his new book, The Censor’s Hand: The Misregulation of Human-Subject Research, law professor Carl Schneider charges that IRB abuses are inherent to the design of the system.

[Scott Jaschik, “‘The Censor’s Hand’,” Inside Higher Ed, June 3, 2015.]

Schneider expands:

The problem is that the IRB system is so fundamentally misconceived that it is virtually a model of how to regulate badly. Good regulation is accountable, but IRBs are effectively answerable to nobody. Good regulation has clearly defined jurisdictional limits, but IRBs may intervene as they wish. Good regulation is guided by clear rules, but IRBs have little more than empty principles. Good regulation is disciplined by fair procedures, but IRBs can ignore every fundamental precept of due process. Good regulation is transparent, but IRBs need not even explain – much less justify – their decisions. Good regulation is staffed by experts, but IRB members cannot be competent in all the specialties they regulate. Good regulation has manageable workloads, but IRBs regulate more details of more research in more ways than they can review responsibly, and they have steadily broadened and intensified their hold over research.

In short, the IRB system makes unreliable decisions because it is lawless and unaccountable, because its organization, procedures, membership and imperialism are so inappropriate. The problem is not regulation, it is bad regulation.

Schneider thinks that the misregulation of social science is particularly bad, but warns that IRBs sap medical progress as well. See The Costs of Ethical Review, Part II.

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