Rodrigues H C M L Catarina, Oerlemans A J M Anke, van den Berg P P Paul
Universitair Medisch Centrum Groningen, afd. Obstetrie en Gynaecologie, Groningen, the Netherlands.
Ned Tijdschr Geneeskd. 2011;155(49):A3846.
When a randomized controlled trial (RCT) that has potentially therapeutic benefits for research subjects is conducted, the line between treatment and research is often difficult to draw. However, in order to protect the well-being and rights of prospective research subjects and to ensure that they are not subjected to harmful and pointless research, the distinction between normal care and scientific research must be thoroughly explained. There has to be clear-cut 'equipoise', i.e. uncertainty in physician, patient and investigator regarding the outcome of the study. Strong patient preference for the experimental arm of an RCT does not entail a right to have access to it, as by definition it represents an option of unproven safety or efficacy (equipoise). Only in a therapeutic context do patients have the right to receive the best available care and a right to discuss their treatment preferences with their physicians. A careful informed consent procedure that clarifies the differences between research and therapy, and that emphasizes the experimental nature of trial arms, should be in place prior to randomization.
当开展一项对研究对象可能具有治疗益处的随机对照试验（RCT）时，治疗与研究之间的界限往往很难划分。然而，为了保护潜在研究对象的福祉和权利，并确保他们不会遭受有害且无意义的研究，必须充分解释常规护理与科学研究之间的区别。必须存在明确的“ equipoise”，即医生、患者和研究者对研究结果存在不确定性。患者对RCT试验组有强烈偏好并不意味着有权接受该试验组治疗，因为从定义上讲，这代表着一种未经证实的安全性或有效性的选择（equipoise）。只有在治疗背景下，患者才有权利接受可获得的最佳护理，并有权利与医生讨论他们的治疗偏好。在随机分组之前，应实施仔细的知情同意程序，该程序要阐明研究与治疗之间的差异，并强调试验组的实验性质。
