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Voluntariness of Consent to Research: A Conceptual Model Whether research decisions are voluntary is difficult to determine. The law of informed consent provides a useful conceptual model.

Informed consent to research derives from a legal doctrine that calls for potential research subjects to have meaningful choice. It comprises three elements: relevant information is provided to a person who is competent to make a decision, and who is situated to do so voluntarily. However, existing literature on informed consent has focused extensively on the information disclosed and how well it is communicated—and, more recently, on the theoretical and practical aspects of the assessment of decisional competence—while the nature of the requirement of voluntariness has yet to be fully explored.

A useful model of voluntariness can be found, however, in the doctrine of informed consent. With this model in hand, one describe the constraints on voluntariness that may appear in the research setting, identify a research agenda to advance our understanding of voluntariness in practice, and begin to see how the proposed model might be operationalized to detect problematic restrictions on voluntariness in consent to research.

Informed consent to research derives from a legal doctrine that calls for potential research subjects to have meaningful choice. It comprises three elements: relevant information is provided to a person who is competent to make a decision, and who is situated to do so voluntarily. However, existing literature on informed consent has focused extensively on the information disclosed and how well it is communicated—and, more recently, on the theoretical and practical aspects of the assessment of decisional competence—while the nature of the requirement of voluntariness has yet to be fully explored.

A useful model of voluntariness can be found, however, in the doctrine of informed consent. With this model in hand, one describe the constraints on voluntariness that may appear in the research setting, identify a research agenda to advance our understanding of voluntariness in practice, and begin to see how the proposed model might be operationalized to detect problematic restrictions on voluntariness in consent to research.
Paul S. Appelbaum, Charles W. Lidz, and Robert Klitzman, "Voluntariness of Consent to Research: A Conceptual Model," Hastings Center Report 39, no 1 (2009): 30-39.