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The case for evidence-based rulemaking in human subjects research
1Environmental Studies and Bioethics, New York University, 285 Mercer 9th Floor, New York, NY, 10003, USA. sachs@nyu.edu
The American Journal of Bioethics : AJOB
|June 8, 2010
Summary
Rules for human subjects research, like the Declaration of Helsinki, may be policy, not strict ethical mandates. Evidence is needed to refine these research policies for better outcomes.
Area of Science:
- Bioethics
- Research Ethics
- Medical Law
Background:
- Canonical pronouncements on human subjects research, including the Declaration of Helsinki and the Belmont Report, provide foundational rules.
- A key debate exists on whether these rules represent true ethical obligations or are practical policy guidelines.
Purpose of the Study:
- To critically examine the status of rules governing human subjects research.
- To determine if these rules are ethical imperatives or policy instruments designed to achieve specific research goals.
Main Methods:
- Conceptual analysis of ethical rules versus policy rules.
- Skeptical inquiry into the ethical obligatoriness of current human subjects research regulations.
Main Results:
- Argues for skepticism regarding the inherent ethical obligatoriness of current human subjects research rules.
- Highlights the lack of empirical evidence on the effects of various policy approaches in human subjects research.
Conclusions:
- Human subjects research rules should be viewed as starting points, not definitive ethical facts.
- Future revisions of research policies must be evidence-based, focusing on achieving legitimate research goals.
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