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.