title: Physician response to informed consent regulations for randomized clinical trials.
abstract: To improve our understanding of physician reluctance to participate in randomized clinical trials, we examined physician responses to the regulation of obtaining written informed consent. Between June 1984 and February 1985 a purposive sample of 170 breast cancer specialists from eight countries completed a self-administered questionnaire and follow-up interview. The sample included 90 medical oncologists, 65 surgeons, and 29 radiotherapists. Responses to individual questions are presented in three global categories: (1) physician role--physicians believed that their view of their professional "self" was not compatible with informed consent regulations; (2) physician autonomy--physicians perceived a loss of individual decision-making power and an increase in professional accountability; and (3) physician-patient relationship--physicians stated that informed consent regulations influenced what they told trial patients and affected the ensuing doctor-patient relationship. Respondents developed complex methods to accommodate the incongruities they perceived between their view of their professional self and the need to obtain informed consent.
mesh_terms: D002986:Clinical Trials as Topic; D032962:Consent Forms; D030881:Disclosure; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D038622:Internationality; D010819:Physician's Role; D010817:Physician-Patient Relations; D011897:Random Allocation; D035844:Researcher-Subject Relations; D012380:Role; D012941:Social Responsibility; D036302:Therapeutic Human Experimentation