Voluntariness of Consent to Research: A Conceptual Model: A Good Deal of Policy and Practice in Human Subjects Research Aims to Ensure That when Subjects Consent to Research, They Do So Voluntarily. To Date, However, Voluntariness and Its Impairment Have Been Poorly Conceptualized and Studied. The Legal Doctrine of Informed Consent Could Provide a Useful 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. (1) The first definitive statement of the importance of consent as a prerequisite to research participation, the tribunal's decision in the Doctors' Trial at Nuremberg, underscored the crucial role of voluntariness in that process: "The voluntary consent of the human subject is absolutely essential." (2) 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. (3) Current controversies over the extent to which a variety of recruitment approaches may compromise voluntary consent to research have raised concerns about the topic. Such concerns are usually invoked under the rubrics of coercion or undue influence. The federal regulations on human subjects research refer to both concepts but define neither. (4) However, the regulations identify several subject groups--including children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons--as "likely to be vulnerable to coercion or undue influence." They also indicate that a criterion for institutional review board approval of such research is that "additional safeguards have been included in the study to protect the rights and welfare of these subjects." (5)