Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
Dynamic Consent: a potential solution to some of the challenges of modern biomedical research
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DOI：
10.1186/s12910-016-0162-9
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发表时间：
2017-01-25
影响因子：
2.7
通讯作者：
Mascalzoni, Deborah
中科院分区：
文献类型：
--
作者：
Budin-Ljosne, Isabelle;Teare, Harriet J. A.;Mascalzoni, Deborah
背景：技术创新促进了现代生物医学研究方式的快速变化。研究人员越来越需要支持适应性和灵活的方法，以适应这些创新，并遵守道德，法律的和监管要求。本文探讨了动态同意如何提供解决方案，以解决研究人员邀请个人参与研究时遇到的挑战，并在不断变化的环境中随着时间的推移对他们进行跟踪。由牛津大学和成本行动芯片我联合组织的跨学科研讨会聚集了临床医生，研究人员，伦理学家，律师，研究参与者和患者代表讨论使用动态同意的经验，以及这种使用如何促进特定研究任务的执行。在研讨会期间收集的数据使用内容分析方法进行了分析。结果：动态同意可以提供实用，可持续和面向未来的解决方案，以应对与参与者招募，获得知情同意，参与者保留和同意管理相关的挑战，并可能带来经济效益。动态同意为研究人员和研究参与者之间的持续沟通提供了机会，可以对研究产生积极影响。Dynamic Consent支持跨部门、跨境方法和大规模数据共享。虽然它相对容易建立和维护，它的实施将需要研究人员重新考虑他们与研究参与者的关系，并采用新的程序。
Background: Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment.Methods: An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach.Results: Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies.Conclusions: Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.