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Can informed consent to research be adapted to risk?
Danielle Bromwich1, Annette Rid2
1Department of Philosophy, University of Massuchessetts, Boston, USA.
Journal of Medical Ethics
|October 30, 2014
Summary
Adapting informed consent to research risks is crucial. This study proposes a framework for risk-adapted informed consent, ensuring autonomous authorization even in unfavorable risk-benefit scenarios for participants.
Area of Science:
- Bioethics
- Research Ethics
- Regulatory Science
Background:
- Current ethical frameworks for research are criticized for hindering valuable studies.
- Informed consent standards are debated for adaptation to research participation risks.
- Existing proposals focus on research with favorable risk-benefit profiles for participants.
Purpose of the Study:
- To adapt the standard view of informed consent (autonomous authorization) to research risks.
- To address concerns about autonomous authorization in risk-adapted informed consent.
- To explore consent adaptation beyond risk-benefit profiles.
Main Methods:
- Theoretical argumentation on informed consent principles.
- Analysis of existing ethical and regulatory frameworks for research.
- Development of a conceptual model for risk-adapted informed consent.
Main Results:
- The standard view of informed consent can be adapted to research risk, even without a favorable risk-benefit profile.
- Current and proposed consent standards may not be adequately risk-calibrated.
- Consent standards require adaptation to factors beyond just risk.
Conclusions:
- Risk-adapted informed consent is feasible and necessary for ethical research.
- A nuanced approach to informed consent is needed, considering multiple factors.
- This work informs future ethical guidelines for human subjects research.
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