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The concept of voluntary consent
Robert M Nelson1, Tom Beauchamp, Victoria A Miller
1US Food and Drug Administration, Silver Spring, MD 20993, USA. robert.nelson@fda.hhs.gov
The American Journal of Bioethics : AJOB
|August 3, 2011
Summary
Voluntary informed consent requires intentionality and freedom from controlling influences. This research defines voluntariness and proposes an instrument to assess control perceptions for better consent policies.
Area of Science:
- Bioethics
- Philosophy of Action
- Psychology
Background:
- Voluntary informed consent is crucial in research and clinical settings.
- Existing definitions of voluntariness lack clarity and empirical grounding.
- The concept of voluntariness is complex, influenced by intentionality and external controls.
Purpose of the Study:
- To analyze the concept of voluntariness.
- To define necessary and sufficient conditions for voluntary action.
- To explore implications for voluntary informed consent requirements.
Main Methods:
- Conceptual analysis of voluntariness.
- Evaluation of existing theories of voluntariness.
- Proposal of a non-value-laden definition of voluntariness.
- Discussion of empirical assessment methods for control perceptions.
Main Results:
- Voluntary action requires intentionality and substantial freedom from controlling influences.
- Authenticity is not a necessary condition for voluntariness.
- Voluntariness is context-dependent, influenced by circumstances and agent capacities.
- A Decision Making Control Instrument is proposed for empirical assessment.
Conclusions:
- The proposed definition of voluntariness offers a clear, empirically testable framework.
- Empirical data on perceived control can inform policies for obtaining voluntary informed consent.
- This approach provides a non-value-laden perspective on voluntariness in bioethics.
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