In law, with rare exception such as legislative action, change is evolutionary and methodical. Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law. Nevertheless, compelling evidence will pave the road to change within the law. Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue.
This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform. Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards. Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent.1
Currently, the states are almost evenly split between two types of standards for informed consent - the physician-based standard, effective in 25 states, and the patient-based standard, effective in 23 states and the District of Columbia.2 Physician-based standards generally require physicians to inform a patient of the risks, benefits and alternatives to a treatment in the same manner that a "reasonably prudent practitioner" in the field would.3 On the other hand, patient-based standards hold physicians responsible for providing patients with all information on the risks, benefits and alternatives to a treatment that a "reasonable patient" would attach significance to in making a treatment decision.4 As can be seen in the cases listed in Appendix A, while each state may have its own variation on the language of its informed consent standard, they are quite representative of classification, and so, we will discuss the physician and patient-based standards each as a unified standard for the remainder of the paper.
Recent findings of health-services research challenge the validity of important assumptions that underlie our two informed consent standards. For instance, research performed by John Wennberg and colleagues demonstrates that around one-third of all medical decisions should depend largely on the values and preferences of the patient, rather than the norms of physician practice, as is the law under the physician-based standard.5 Patient preferences for information disclosure, risk taking, quality of life outcomes and tolerance of side effects differ greatly amongst the patient population,6 yet variations in treatment decisions often do not reflect differences in patient choice.7 In cases where patient lifestyle, personal preferences and values are indicative of the most appropriate treatment choice, physicians are not in the best position to make treatment decisions and should not limit disclosure of alternatives. In addition, research by Deb Feldman-Stewart and colleagues demonstrates that patients vary widely in their disclosure preferences and needs,8 indicating that contrary to the principles of individual autonomy and self-determination, our objective legal standards of informed consent that depend on the informational needs of a "reasonable patient" may deny many patients the amount of information they require to give an informed consent to treatment.
In the last decade, a small but distinguished group of medical and even some legal scholars have sought to address this dilemma by calling for a revision of our current methods of informed consent in favor of shared medical decision-making.9 Shared medical decision-making is a process in which the physician shares with the patient all relevant risk and benefit information on all treatment alternatives and the patient shares with the physician all relevant personal information that might make one treatment or side effect more or less tolerable than others. …