Richard Milne, PhD, Institute of Public Health, University of Cambridge, 2 Wort's Causeway Cambridge, UK, CB1 8RN,
J Prev Alzheimers Dis. 2017;4(2):125-131. doi: 10.14283/jpad.2017.5.
There is growing interest in the development of novel approaches to secondary prevention trials in Alzheimer's disease to facilitate screening and recruitment of research participants and to reduce the time and costs associated with clinical trials. Several international research collaborations are setting up research infrastructures that link existing research cohorts, studies or patient registries to establish 'trial-ready' or 'readiness' cohorts. From these cohorts, individuals are recruited into clinical trial platforms. In setting up such research infrastructures, researchers must make ethically challenging design decisions in at least three areas: re-contacting participants in existing research studies, obtaining informed consent for participation in a readiness cohort, and disclosure of Alzheimer's disease-related biomarkers. These ethical considerations have been examined by a dedicated workgroup within the European Prevention of Alzheimer's Dementia (EPAD) project, a trans-European longitudinal cohort and adaptive proof-of-concept clinical trial platform. This paper offers recommendations for the ethical management of re-contact, informed consent and risk disclosure which may be of value to other research collaborations in the process of developing readiness cohorts for prevention trials in Alzheimer's disease and other disease areas.
人们越来越关注开发阿尔茨海默病二级预防试验的新方法，以促进研究参与者的筛选和招募，并降低临床试验相关的时间和成本。几个国际研究合作正在建立研究基础设施，将现有的研究队列、研究或患者登记处联系起来，建立“试验就绪”或“准备就绪”队列。从这些队列中招募个体进入临床试验平台。在建立这种研究基础设施时，研究人员必须在至少三个方面做出具有挑战性的伦理设计决策：重新联系现有研究中的参与者，获得参与准备队列的知情同意，以及披露与阿尔茨海默病相关的生物标志物。欧洲预防阿尔茨海默病痴呆症 (EPAD) 项目的一个专门工作组对这些伦理考虑进行了研究，该项目是一个跨欧洲纵向队列和适应性概念验证临床试验平台。本文提出了重新联系、知情同意和风险披露的伦理管理建议，这对于其他正在为阿尔茨海默病和其他疾病领域的预防试验开发准备队列的研究合作可能具有价值。
