Saturday, June 6, 2015

Klitzman Wants "Case Law." As Did Katz, 42 Years Ago

In an opinion piece drawn from his new book, The Ethics Police?, Robert Klitzman calls for IRB transparency and respect for precedent. That is a good idea, and one that should have been implemented decades ago.

[Robert Klitzman, “Who Polices the ‘Ethics Police’?,” CNN, May 26, 2015]

Here’s Klitzman:

Boards that remain closed to researchers should be more open. A body of “case law” should be built, based on documented precedents. Interpretations and applications of principles in specific cases should, as much as possible, be openly vetted.

As I’ve mentioned in 2008, 2010, 2011, and 2014, law professor Jay Katz understood this all back in 1973, before the enactment of the National Research Act and 45 CFR 46. As he testified to the Senate,

The review committees work in isolation from one another, and no mechanisms have been established for disseminating whatever knowledge is gained from their individual experiences. Thus, each committee is condemned to repeat the process of finding its own answers. This is not only an overwhelming, unnecessary and unproductive assignment, but also one which most review committees are neither prepared nor willing to assume.

[U.S. Senate, Quality of Health Care—Human Experimentation, 1973: Hearings before the Subcommittee on Health of the Committee on Labor and Public Welfare, Part 3 (93d Cong., 1st sess., 1973), 1050].

Katz wanted IRBs to publish their decisions and base new decision on precedent. “The result,” he predicted, “would not only be better thought out decisions, but also a more complex system of controls which, in effect, [would take] into account much broader sources of information as to societal values … I regard such a development, analogous to the experience of the common law, as the best hope, for ultimately providing workable standards for the regulation of the human experimentation process.”

Had the Senate, or the National Commission, or OPRR heeded Katz, we would not have endured decades of overwhelming, unnecessary and unproductive IRB guesswork.

I have a full review of Klitzman’s book in the works. Watch this space.

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