Miller Paul B, Weijer Charles
University of Toronto, Canada.
Kennedy Inst Ethics J. 2003 Jun;13(2):93-118. doi: 10.1353/ken.2003.0014.
When may a physician legitimately offer enrollment in a randomized clinical trial (RCT) to her patient? Two answers to this question have had a profound impact on the research ethics literature. Equipoise, as originated by Charles Fried, which we term Fried's equipoise (FE), stipulates that a physician may offer trial enrollment to her patient only when the physician is genuinely uncertain as to the preferred treatment. Clinical equipoise (CE), originated by Benjamin Freedman, requires that there exist a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. FE and CE are widely understood as competing concepts. We argue that FE and CE offer separable and, in themselves, incomplete justifications for the conduct of clinical trials. FE articulates conditions under which the fiduciary duties of physician to patient may be upheld in the conduct of research. CE sets out a standard for the social approval of research by institutional review boards. Viewed this way, FE and CE are not necessarily competing notions, but rather address complementary moral concerns.
医生在什么时候可以合理地邀请她的患者参加随机临床试验（RCT）呢？对于这个问题的两种回答对研究伦理文献产生了深远影响。由查尔斯·弗里德提出的 equipoise，我们称之为弗里德的 equipoise（FE），规定医生只有在对首选治疗方法真正不确定时，才可以邀请患者参加试验。由本杰明·弗里德曼提出的临床 equipoise（CE）要求，在专业专家群体中，对于首选治疗方法存在一种诚实的、专业的分歧状态。FE 和 CE 被广泛认为是相互竞争的概念。我们认为，FE 和 CE 为开展临床试验提供了可分离且本身并不完整的正当理由。FE 阐明了在研究过程中医生对患者的信托责任得以维护的条件。CE 为机构审查委员会对研究的社会认可设定了一个标准。从这个角度看，FE 和 CE 不一定是相互竞争的概念，而是解决了互补的道德问题。
