Coulehan J L, Schaffner K F, Block M
J Fam Pract. 1985 Sep;21(3):217-22.
In this paper several issues are examined that arise from conducting randomized clinical trials in a family practice setting. The distinctive research tradition in family practice involves a patient's primary care physician performing an experimental investigation that usually, though not invariably, is focused on common health problems. Representative clinical trials are presented as examples that illustrate two ethical difficulties evoked by such research: a potential violation of the primary care physician's therapeutic imperative to provide the best possible treatment for his or her patient, and the likelihood that the type of physician-patient relationship fostered in family practice significantly diminishes the capacity of the patient to give true informed consent. In an attempt to resolve these ethical difficulties, a model of moral reasoning is presented that is based on easily understood ethical principles and is applicable to actual clinical decision making. Using that model, a tentative set of rules or guidelines is offered for implementing clinical trials in family medicine.
本文探讨了在家庭医疗环境中进行随机临床试验所引发的若干问题。家庭医疗独特的研究传统涉及患者的初级保健医生开展实验性研究，该研究通常（但并非总是）聚焦于常见健康问题。文中列举了具有代表性的临床试验案例，以说明此类研究引发的两个伦理困境：一是可能违背初级保健医生为患者提供最佳治疗的治疗义务；二是家庭医疗中所培养的医患关系类型很可能会显著削弱患者给出真正知情同意的能力。为解决这些伦理困境，本文提出了一种基于易于理解的伦理原则且适用于实际临床决策的道德推理模型。运用该模型，为在家庭医学中开展临床试验提供了一套初步的规则或指导方针。
