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Is emergency research without initial consent justified?: the consent substitute model
Emily A Largent1, David Wendler, Ezekiel Emanuel
1National Institutes of Health, 10 Center Dr, Bldg 10, Room 1C118, Bethesda, MD 20892-1156, USA.
Archives of Internal Medicine
|April 28, 2010
Summary
Emergency research without consent is ethically challenging. A consent substitute model with five conditions can ethically justify enrolling patients when initial consent is impossible.
Area of Science:
- Medical Ethics
- Clinical Research
Background:
- Emergency research presents an ethical dilemma regarding informed consent.
- Current international regulations for emergency research without consent are uncertain.
- A widely accepted ethical justification for emergency research without initial consent is lacking.
Purpose of the Study:
- To explore the ethical justification for emergency research without initial informed consent.
- To propose a framework for ethically conducting emergency research when consent is not feasible.
Main Methods:
- Analysis of ethical principles related to informed consent (autonomy, well-being).
- Development of a "consent substitute model" based on five ethical conditions.
Main Results:
- Informed consent values can be upheld through alternative means in emergency research.
- Five conditions for a consent substitute model were identified: responsiveness, comparable risk-benefit ratio, no conflicting preferences, minimal net risks, and prompt consent.
Conclusions:
- The proposed five conditions form an ethical substitute for informed consent in emergency research.
- This consent substitute model provides a framework for ethically navigating emergency research scenarios.
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