Empirical Research on Informed Consent

Article excerpt

An Annotated Bibliography

Obtaining the informed consent of patients and subjects is now an expected part of clinical medicine and research. In concert with strong theoretical justifications, an array of laws, regulations, court cases, policy statements, and professional guidelines emphasize the need for obtaining meaningful informed consent. Moreover, strong popular reactions to alleged failures to obtain consent, such as those in response to human radiation experiments conducted during the Cold War, underscore this professional, legal, and philosophical expectation.

Yet despite broad agreement about the need to obtain informed consent, there is some uncertainty, about how or whether meaningful consent is achieved in practice, whether theoretical understandings of informed consent are useful or practical, and what practices help enhance the possibility that patients and subjects in fact meaningfully consent to treatment or participation in research. These are important empirical questions.

In the wake of the findings and recommendations of the Advisory Committee on Human Radiation Experiments,[1] several federal agencies have initiated efforts to ensure that informed consent is valid and meaningful--for example, proposals for research on informed consent recently solicited by the National Institutes of Health.[2] A necessary first step in such efforts is not only to have a sound understanding of theoretical discussions of informed consent, but also to evaluate how well informed consent has been addressed in clinical medicine and research as an empirical matter. While empirical studies of consent have been conducted, published reports are scattered among the literatures of many different disciplines, including bioethics, geriatrics, medicine, law, psychology, and sociology. Thus these materials can be difficult to identify and locate.

As part of an effort to ensure that patients and research subjects within the Veterans Affairs health care system give meaningful informed consent, we conducted a systematic retrieval of published empirical research on informed consent. This endeavor is important given that the Veterans Health Administration, with its 172 hospitals, 439 clinics and 131 nursing homes, "operates the Nation's largest integrated healthcare system providing care to 3.1 million unique patients with nearly 827 thousand inpatient episodes and over 32 million outpatient visits in 1997."[3] In addition, the Veterans Affairs Research and Development program conducts and funds extensive research throughout the system. Beyond the obvious benefits of ensuring meaningful informed consent for patients and research subjects in these Department of Veterans Affairs activities, as a service to interested scholars, policymakers, clinicians, and others, we share the fruits of our efforts here in the form of an annotated bibliography.

We make no effort here to evaluate the quality of the research reported in the articles noted. Our intent, rather, is to provide a resource by gathering these citations, with a brief description of content, together in a single bibliography. The articles that follow represent published empirical studies concerning informed consent for medical treatment and research with adult patients and subjects only (persons eighteen years of age or older).

Compiling the Bibliography

We developed eight content categories to identify appropriate research questions addressed in the articles, drawing on theoretical work on informed consent as well as the types of empirical studies that might be available for review:[4] decisionmaking capacity (competency to participate in the informed consent process); voluntariness (ability and opportunity to make uncoerced decisions about treatment or participation in research); disclosure (the type of information provided by the clinician or investigator, such as information about procedures, risks, benefits, and alternatives as well as the manner in which it is conveyed to patients or potential subjects); understanding (patients' and potential subjects' comprehension and recall of information presented to them); authorization (the patient's or subject's expression of his or her decision to accept or refuse a proposed treatment or to participate in research); policies and procedures (how informed consent is obtained, including timing of conversations and who obtains consent); recruitment (how interest in participating is encouraged among potential subjects); and consent forms. …