Decision-making and informed consent: A study of the impact of disclosed information

This paper is an empirical and normative study of several problems about informed consent in the law and in biomedical ethics. Its particular focus is on the adequacy of prevailing standards of informed consent in medicine and law. These standards generally govern adequate disclosure on the physician's part, to the relative neglect of the equally significant question, ‘What constitutes a valid consent on the patient's part?’ New empirical data regarding the actual decision-making behavior of patients is presented. It was gathered by studying patients considering whether to consent to the use of nonsurgical contraceptive techniques. Three hypotheses are examined regarding how disclosed information affects the decision-making process. Results indicate that disclosed information is not avowed as the prime determinant of the consent decision, that disclosed information does have some effect on the decision-making process, and that disclosed information does not impair or confuse the decision-making process. In conclusion, a number of implications for major areas of ethics and law are pointed out, with special emphasis on three areas of law: the materiality standard, causation, and the therapeutic privilege.