Informing for consent: Concepts and methods.

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AbstractConsent doctrine seeks to protect individual autonomy and self-determination of potential subjects or patients. It was created and mandated in reaction to perceived abuses in patient/subject and healthcare professional relationships. In part because of the speed in which these occurred, the doctrine was created as an imperative in the absence of solid theoretical and empirical bases on how people acquire and use information. The Informing for Consent framework is presented so that the mandates of can be more fully examined. The implications of this framework and the need for empirical study are discussed with reference to the following areas: when children become competent to self-consent and for which areas in decision making; when competence to self-consent changes during poor physical or mental health; when people become unable to consent; and when protections such as surrogate decision makers should be instituted or removed. The implications to individual professionals and to regulatory bodies are also discussed.Historical Overview of ConsentThe doctrine of seeks to protect the individual autonomy and self-determination of potential subjects or patients (President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1981). While informed consent grew out of an early legal opinion (Schloendorff v. Society of New York Hosp. 211 N.Y. 125, 129 105 N.E. 92, 1914), the modern concept originated with the Nuremberg Code following the atrocities of World War II and became part of the Helsinki agreement of 1964 (see Beecher, 1970; Dalglish, 1976; Levine, 1981; the actual phrase informed consent was first coined in 1957 with Salgo v. Leland Stanford Jr. Univ. Bd. of Trustees, 154 Cal App. 2d 560, 317 P.2d 170, 1957). The intent of the doctrine is to provide a format and a process for communication with people who will be undergoing medical treatment or participating in research. The necessity for formalizing this type of communication grew out of historical abuses of the doctor-patient/researcher-subject relationships both in medicine (see Beecher, 1970) and psychology (e.g., Milgram, 1974; Holroyd & Brodsky, 1977), including the arbitrary and nonconsensual sterilization of persons with mental retardation (Hayman, 1990), infection of persons with mental retardation with hepatitis at Willowbrook (Ervin, 1974), withholding of treatment for syphilis at Tuskegee (Brandt, 1978), nonconsensual observation of people in the Tearoom Trade study (Humphreys, 1970), and deception in the Milgram study (Dalglish, 1976; Milgram, 1974; Levine, 1981). Without such formalization, the type and amount of information and the manner of its presentation varied greatly (Beecher, 1966; Cooke, Tannenbaum & Gray, 1978; Otto, Ogloff & Small, 1991; President's Commission, 1982b). Incomplete or deceptive information has been disclosed to patients and subjects. In other cases no efforts were made to obtain (Barber, 1979; Cooke, Tannenbaum & Gray, 1978; Dalglish, 1976; Ogloff & Otto, 1991; President's Commission, 1981; 1982; Tymchuk & Thompson, 1986). Some practitioners and researchers continue to see as an infringement upon their freedom to practice or to perform research (Dalglish, 1976; President's Commission, 1981; Tymchuk & Thompson, 1986). Others believe that subjects or patients do not wish to know more or will become overwhelmed by the information they receive as part of the process (Dalglish, 1976). However, these perceptions are inaccurate for many groups such as elderly people (e.g., Dalglish, 1976; Lankton, Batchelder & Ominsky, 1977; Ouslander, Tymchuk & Krynski, 1993; Strull, Lo & Charles, 1986; Tymchuk, Ouslander & Rader, 1986).In psychology, the concept of is the same for both research and treatment participation in Canada and the U.S. (Meisel & Roth, 1983; Rozovsky & Rozovsky, 1990; Sinclair, 1993). …