Wednesday, September 24, 2008

Final Comments on Training Requirements

A couple of readers told me my Draft Comments on Training Requirements
proposed an unrealistically burdensome training regime. I don't think that asking researchers and IRBs alike to learn about the documented ethical challenges of a given line of research is unduly burdensome, and neither did the architects of the present system. I have added the following to my comments, which I submitted today:


Lest all this sound like too much work, let me quote the Belmont Report's own recommendations:

the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments . . . The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.
Standardized training does not produce "the accumulation and assessment of information about all aspects of the research," it does not make explicit the "method of ascertaining risks," and, most significantly, it does not provide the IRB or the investigator with "known facts or other available studies." What it does produce is a false sense of expertise among IRB board members, leading to the very "misinterpretation, misinformation and conflicting judgments" against which the National Commission warned.

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