While the patient's right to give informed consent to medical treatment is now well-established both in U.S. law and in biomedical ethics, evidence continues to suggest that the concept has been poorly integrated into American medical practice, and that in many instances the needs and desires of patients are not being well met by current policies.' it appears that the theory and the practice of informed consent are out of joint in some crucial ways. This is particularly true for primary care settings, a context typically ignored by medical ethics literature, but where the majority of doctor-patient encounters occur. Indeed, some have suggested that the concept of informed consent is virtually foreign to primary care medicine where benign paternalism appropriately reigns and where respect for patient autonomy is almost completely absent.
it is worth asking whether current legal standards for informed consent tend to resolve the problem or to exacerbate it. I will maintain that accepted legal standards, at least in the form commonly employed by courts, send physicians the wrong message about what is expected of them. An alternative standard that would send physicians the correct message, a conversation standard, is probably unworkable legally. As an alternative, I will propose a transparency standard as a compromise that gives physicians a doable task and allows courts to review appropriately. I must begin, however, by briefly identifying some assumptions crucial to the development of this position even though space precludes complete argumentation and documentation. Crucial Assumptions
Informed consent is a meaningful ethical concept only to the extent that it can be realized and promoted within the ongoing practice of good medicine. This need not imply diminished respect for patient autonomy, for there are excellent reasons to regard respect for patient autonomy as a central feature of good medical care. Informed consent, properly understood, must be considered an essential ingredient of good patient care, and a physician who lacks the skills to inform patients appropriately and obtain proper consent should be viewed as lacking essential medical skills necessary for practice. It is not enough to see informed consent as a nonmedical, legalistic exercise designed to promote patient autonomy, one that interrupts the process of medical care.
However, available empirical evidence strongly suggests that this is precisely how physicians currently view informed consent practices. Informed consent is still seen as bureaucratic legalism rather than as part of patient care. Physicians often deny the existence of realistic treatment alternatives, thereby attenuating the perceived need to inform the patient of meaningful options. While patients may be informed, efforts are seldom made to assess accurately the patient's actual need or desire for information, or what the patient then proceeds to do with the information provided. Physicians typically underestimate patients' desire to be informed and overestimate their desire to be involved in decisionmaking. Physicians may also view informed consent as an empty charade, since they are confident in their abilities to manipulate consent by how they discuss or divulge information.3
A third assumption is that there are important differences between the practice of primary care medicine and the tertiary care settings that have been most frequently discussed in the literature on informed consent. The models of informed consent discussed below typically take as the paradigm case something like surgery for breast cancer or the performance of an invasive and risky radiologic procedure. It is assumed that the risks to the patient are significant, and the values placed on alternative forms of treatment are quite weighty. Moreover, it is assumed that the specialist physician performing the procedure probably does a fairly limited number of procedures and thus could be expected to know exhaustively the precise risks, benefits, and alternatives for each. …