Tuesday, August 30, 2011

The Years Spin By

In his presentation to the Presidential Commission for the Study of Bioethical Issues today, Ezekiel Emanuel showed some textual slides that were visible during the live webcast but do not show up--at least on my browsers--when I replay the recording.

One of these slides featured a timeline of events leading to the current system of human subjects protections. That timeline featured two common errors.

First, Emanuel dated the Belmont Report to 1979. You will see this date a lot: on the NIH website in a blurb for Belmont Revisited, and--until I fixed it just now--on the Wikipedia entry, .

But read the report itself, and there's the date, 30 September 1978, at the top of each of the four transmission letters. The report even has a DHEW publication number, 78-0012, indicating the year in which it was published.

True, the report appeared in the Federal Register on 18 April 1979. But dating the Belmont Report to April 1979 is like dating the Declaration of Independence to August 1776, because that's when it was engrossed. We don't launch fireworks on August 2.

Second, Emanuel suggested that 45 CFR 46 was first promulgated in 1981. In fact, the first version of 45 CFR 46 was promulgated on 30 May 1974.

These errors are of little consequence by themselves. But I would like to think that an acquaintance with the history of IRB policy--an acquaintance complete enough that getting these dates right becomes second nature--would help today's policymakers gauge the probable outcomes of the various proposals on the table.

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