Why Study Informed Consent?
Madam: The annotated bibliography of 377 empirical research studies on informed consent ("Empirical Research on Informed Consent: An Annotated Bibliography," HCR, January-February 1999) is dismaying. The study of informed consent has become a cottage industry, usually funded by grants. But what is the point of it all? Assuredly, such studies do not inform whether in a particular case there has been an informed consent. Is it to inform whether to use video or written forms? Whatever happened to common sense?
The studies on informed consent were sparked by the development in law of the doctrine of informed consent. In large measure, however, that doctrine was a tactic to provide a cause of action in cases of unsuccessful or poor outcome even though consent to the treatment was given and even though negligence in treatment cannot be established. It provided flexibility in outcome in litigation--after all, one can never be sure what information about what risk must be disclosed and one can never be sure about the competence of a patient in understanding the information.
The studies set out in the bibliography tend to be interesting, but from a practical point of view, they could just as well have been about abracadabra.
Ralph Slovenko Wayne State University
Jeremy Sugarman, Douglas C. McCrory, Donald Powell, Alex Krasny, Betsy Adams, Eric Ball, and Cynthia Cassell reply:
We were frankly surprised to receive Professor Slovenko's reaction to our annotated bibliography of empirical studies on informed consent. As described in our introduction, we limited our project to assembling and categorizing these studies so they might serve as a resource for those who are interested in evaluating and perhaps improving the informed consent process in practice. Answering adequately Professor Slovenko's provocative and important questions regarding the "point of it all" would be a separate project from the one in which we engaged.
Nevertheless, studying informed consent seems to be important for reasons that extend well beyond "whether in a particular case there has been informed consent." Informed consent is now, both ethically and legally, an expected component of clinical care and research. While we do not deny Professor Slovenko's thumbnail history of the evolution of the legal doctrine of informed consent for medical treatment, it would seem inappropriate merely to wait for cases with bad outcomes to march through the courts in order to refine the practice of informed consent. Doing so would miss the ethical imperative to obtain meaningful informed consent, not only for treatment but also for research. Rather, like most interventions in clinical care and research, informed consent should be tested rigorously. As the history of medicine makes clear, adopting interventions without evaluation might inadvertently expose large numbers of patients and research subjects to inadequate methods of obtaining consent.
Moreover, as Professor Slovenko observes, empirical research on informed consent has been rather like a cottage industry, with investigators dispersed among various disciplines. Although this movement has contributed a great number of empirical studies to the peer-reviewed literature, the dissemination of this knowledge has been impaired by the factors outlined in our introduction to the supplement. We look forward to the products of an "industrial revolution" fueled in part by funding and regulatory agencies that have begun to recognize the importance of this type of research. Ultimately, we hope that it results in an improved informed consent process. Contra Professor Slovenko, this suggests the need for additional well-designed and well-funded empirical research on informed consent, guided by a careful review of the literature.
Madam: The Geron Ethics Advisory Board invited and therefore welcomes responses and dialogue on the important ethical issues surrounding stem cell research. …