Informed consent for biobanking: consensus-based guidelines for adequate comprehension
Informed consent for biobanking: consensus-based guidelines for adequate comprehension
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DOI：
10.1038/gim.2014.102
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发表时间：
2015-03-01
影响因子：
8.8
通讯作者：
Weinfurt, Kevin P.
中科院分区：
文献类型：
--
作者：
Beskow, Laura M.;Dombeck, Carrie B.;Weinfurt, Kevin P.
目的：联邦法规和最佳实践指南确定了在知情同意过程中应传达给潜在生物库参与者的信息类别。然而，不确定性仍然存在，这一信息的参与者必须了解提供有效的consent.Methods：我们进行了德尔菲过程中定义“充分的理解”的背景下，生物库的同意。这一过程涉及对51名专家组成的不同小组进行的一系列三次在线调查，其中包括基因组科学家、生物库管理人员、伦理和政策专家以及社区和参与者代表。我们寻求共识（>70%的协议）关于参与者应该知道什么样的具体细节16 biobank同意topics.Results：共识达成了15的16个同意topics.Results。例外的是关于遗传信息非歧视法所需的理解。结论：我们的德尔菲过程是成功的，在确定一套简明的关键点，潜在的参与者必须掌握提供有效的同意生物库。个人作出知情选择所需的足够知识水平是改进同意书和程序的基础，也是评估其他干预措施提高理解力的有效性的绝对衡量标准。
Purpose: Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent.Methods: We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent. The process involved an iterative series of three online surveys of a diverse panel of 51 experts, including genome scientists, biobank managers, ethics and policy experts, and community and participant representatives. We sought consensus (>70% agreement) concerning what specific details participants should know about 16 biobank consent topics.Results: Consensus was achieved for 15 of the 16 consent topics. The exception was the comprehension needed regarding the Genetic Information Nondiscrimination Act.Conclusion: Our Delphi process was successful in identifying a concise set of key points that prospective participants must grasp to provide valid consent for biobanking. Specifying the level of knowledge sufficient for individuals to make an informed choice provides a basis for improving consent forms and processes, as well as an absolute metric for assessing the effectiveness of other interventions to improve comprehension.