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The case for evidence-based rulemaking in human subjects research.

Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the eth...

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Published in:American Journal of Bioethics Vol. 10; no. 6; pp. 3 - 14
Main Author: Sachs B
Format: review tables/charts Journal Article
Published: Taylor & Francis Ltd Jun2010
Online Access:View this record in EBSCOhost
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      pub: Taylor & Francis Ltd
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        atl: The case for evidence-based rulemaking in human subjects research.
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        au: Sachs B
        affil: New York University
      sug:
        subj:
          Protection of Human Subjects
          Public Policy
          Research Subjects
          Research, Medical Ethical Issues
          Consent (Research)
          Decision Making
          Government Regulations
          Health Services Accessibility
          Institutional Review
          Research Personnel
          Research Protocols
          Research Subject Recruitment
          Study Design
          United States
          Validity
      ab: Here I inquire into the status of the rules promulgated in the canonical pronouncements on human subjects research, such as the Declaration of Helsinki and the Belmont Report. The question is whether they are ethical rules or rules of policy. An ethical rule is supposed to accurately reflect the ethical fact (the fact that the action the rule prescribes is ethically obligatory), whereas rules of policy are implemented to achieve a goal. We should be skeptical, I argue, that the actions prescribed by the rules are ethically obligatory, and consequently we should focus our attention on how to craft the rules so as to promote the legitimate goals of human subjects research. Unfortunately, this cannot be done without evidence about the likely effects of various candidate policies-evidence we currently lack. Therefore, we should take the rules as mere starting points, subject to revision as the evidence comes in.
      pubtype: Academic Journal
      doctype:
        review
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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