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

Article excerpt

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)

Potentially impaired voluntariness has also been raised as an issue in numerous other contexts in the bioethics literature on consent to research. These include, but are not limited to, when:

1) substantial monetary or other compensation is offered in exchange for entering a research study; (6)

2) subjects are recruited by their own physicians or in facilities where they are receiving care and may be hesitant to antagonize caregivers by refusing to participate, especially if they are poor, elderly, or suffering from chronic conditions; (7)

3) subjects are being recruited from traditional societies in international research and are thought to be wholly subordinate to a person in a position of authority (for example, a husband or tribal leader); (8)

4) drug abusers are recruited for studies that involve the administration of their drug of choice or are paid for participation and thought likely to use the money to purchase drugs; (9)

5) involuntarily committed psychiatric or substance abuse patients are recruited for research; (10) and

6) patients who otherwise lack access to medical care are invited to participate in studies that promise treatment for their conditions. (11)

A good deal of policy and practice regarding human subjects research has been based on assumptions regarding situations that may impair voluntariness. Many IRBs have policies that limit the amount of compensation that can be offered to subjects, although compensation practices vary widely even within the United States, and investigators are often not allowed to advertise the amount offered. (12) Some have suggested that physicians not be allowed to recruit their own patients as subjects, especially for studies involving more than minimal risk, and anecdotal evidence suggests that some IRBs may already bar this practice. Federal regulations sharply limit the kind of research that can be conducted in prisons, mandating rigorous review even for permitted categories of investigations, such as minimal risk studies of criminal behavior and incarceration. (13) Other limitations are placed on research with pregnant women and children. (14) And a variety of protections have been suggested for subjects in international and drug abuse studies, which now receive more careful review, in substantial part because of concerns about coercion. …