Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

In this eye-opening look at the doctor-patient decision-making process, physician and law professor Jay Katz examines the time-honored belief in the virtue of silent care and patient compliance. Historically, the doctor-patient relationship has been based on a one-way trust -- despite recent judicial attempts to give patients a greater voice through the doctrine of informed consent. Katz criticizes doctors for encouraging patients to relinquish their autonomy, and demonstrates the detrimental effect their silence has on good patient care. Seeing a growing (...) need in this age of medical science and sophisticated technology for more honest and complete communication between physician and patients, he advocates a new, informed dialogue that respects the rights and needs of both sides. In a new foreword to this edition of The Silent World of Doctor and Patient , Alexander Morgan Capron outlines the changes in medical ethics practice that have occurred since the book was first published in 1984, paying particular attention to the hotly debated issues of physician-assisted suicide and informed consent in managed care. (shrink)