Independent, Edinburgh, UK.
Centre for Evidence-Based Medicine, Department of Primary Care, University of Oxford, Oxford OX2 6GG, UK.
J R Soc Med. 2021 Nov;114(11):525-530. doi: 10.1177/01410768211049972.
The current version of the Declaration of Helsinki states that 'the benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention(s) … '. This wording implies that it is acceptable for patients to be assigned to receive an unproven new intervention and to be denied a best current proven intervention. We assert that patients being invited to participate in controlled trials cannot, ethically, be expected to forego proven beneficial forms of care. Patients being treated in controlled trials should not knowingly be disadvantaged compared with similar patients being treated in usual clinical care, where they have access to beneficial care. In this article, we have tried to separate for discussion 'the withholding of effective care from trial participants', 'informed consent to treatment', 'blinding' and 'use of placebos'.
现行版《赫尔辛基宣言》指出,“新干预措施的益处、风险、负担和有效性必须与当前最佳已证实干预措施的益处、风险、负担和有效性进行比较测试……”。这一措辞意味着,将患者分配接受未经证实的新干预措施而拒绝提供最佳当前已证实干预措施是可以接受的。我们断言,邀请患者参加对照试验,从伦理上讲,不能期望他们放弃已证实的有益治疗形式。在对照试验中接受治疗的患者不应与在通常临床护理中接受治疗的类似患者相比处于不利地位,因为后者可以获得有益的护理。在本文中,我们试图将“对试验参与者的有效治疗的保留”、“治疗的知情同意”、“盲法”和“安慰剂的使用”分开讨论。