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The Normative Power of Consent and Limits on Research Risks
Aaron Eli Segal1, David S Wendler1
1Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892 USA.
Ethical Theory and Moral Practice : an International Forum
|October 25, 2024
Summary
This study argues that ethical limits on research risks for adults stem from within informed consent itself, not external factors like public perception. It establishes that certain risks are inherently unacceptable, regardless of consent or public trust considerations.
Area of Science:
- Bioethics
- Research Ethics
- Medical Ethics
Background:
- Current research regulations lack explicit risk limits for consenting adults.
- Review committees often deem certain risks too high, even with consent.
- Existing justifications for risk limits rely on external factors like public trust.
Purpose of the Study:
- To propose an alternative justification for limiting research risks for consenting adults.
- To provide a stronger conceptual basis for identifying unacceptable research risks.
- To explore the internal limitations of informed consent in permitting ethically problematic risks.
Main Methods:
- Conceptual analysis of ethical justifications for research risk limitations.
- Examination of the relationship between informed consent and ethically permissible actions.
- Critique of external justifications for risk limits, such as public trust.
Main Results:
- External justifications for risk limits are insufficient as they depend on public perception.
- Limits on research risks for consenting adults are derived from internal constraints within informed consent.
- Informed consent has inherent limitations on what it can ethically permit.
Conclusions:
- Some research risks are ethically unacceptable irrespective of participant consent or public reaction.
- A robust ethical framework for research must acknowledge inherent limits on acceptable risk.
- This internal justification provides a more stable foundation for research ethics review.
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