An absence of evidence in 'evidence-based rulemaking'
In the last paragraph of a very interesting paper about the normative status of the consensus rules protecting human subjects participating in research, in which he establishes an important distinction between ethical and policy rules, Sachs (2010) asserts that “the policy-oriented approach is the scientific approach, and we should hope that the research community will embrace the scientific approach to regulation as wholeheartedly as they already embrace the scientific approach to medicine…Until we have the answers, our rules remain unproven” (3, emphasis added).
Despite the paper's title, Sachs says little about how and what evidence should be generated, and even less about how that evidence should be evaluated and incorporated into the rules of human subjects protection. He relegates consideration of this matter to two footnotes, describing in vague terms possible prospective or survey studies that could be mounted to determine whether or not there is evidence providing “robust support” (3) or justification for the policy recommendations.
Specifying the purpose and design of empirical research is critical to an evidence-based approach. We must be clear what combination of research goals and designs are best suited to informing policy recommendations. Whether we conduct or evaluate cross-sectional, observational, or experimental studies matters a great deal to whether and what kind of inferences or conclusions we are able to make. ...
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