Informed consent for return of incidental findings in genomic research
Informed consent for return of incidental findings in genomic research
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DOI：
10.1038/gim.2013.145
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发表时间：
2014-05-01
影响因子：
8.8
通讯作者：
Chung, Wendy K.
中科院分区：
文献类型：
--
作者：
Appelbaum, Paul S.;Waldman, Cameron R.;Chung, Wendy K.
目的：研究者面临着如何获得同意归还基因组研究中偶然发现的困境。我们对研究者和研究参与者进行了调查和访谈，目的是为如何塑造知情同意过程提供建议。方法：我们对通过NIH RePORTER数据库确定的254名美国遗传学研究人员进行了在线调查，从2011年美国人类遗传学会会议上提取了摘要，并对28名基因组研究人员和20名研究参与者进行了定性半结构化访谈。结果：大多数研究人员和参与者赞同披露有关附带结果返回的广泛信息，包括风险，益处，对家庭成员的影响，数据安全和程序，在死亡或丧失能力的情况下返回结果以及重新联系。然而，大多数研究人员都愿意投入30分钟或更少的时间在这个过程中，并表示担心披露;信息会压倒参与者，许多参与者自己的共同关注。研究者和参与者对应该披露的信息量的看法与研究环境的实际现实之间存在脱节，包括同意讨论的时间。这有力地表明，需要对知情同意程序采取创新办法。
Purpose: Researchers face the dilemma of how to obtain consent for return of incidental findings from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process.Methods: We performed an online survey of 254 US genetic researchers identified through the NIH RePORTER database, abstracts from the 2011 American Society of Human Genetics meeting, and qualitative semi-structured interviews with 28 genomic researchers and 20 research participants.Results: Most researchers and participants endorsed disclosure of a wide range of information about return of incidental findings, including risks, benefits, impact on family members, data security, and procedures, for return of results in the event of death or incapacity and for recontact. However, most researchers were willing to devote 30 min or less to this process and expressed concerns that disclosed; information would overwhelm participants, a concern shared by many participants themselves.Conclusion: There is a disjunction between the views of investigators and participants about the amount of information that should be I disclosed and the practical realities of the research setting, including the time available for consent discussions. This strongly suggests the need for innovative approaches to the informed consent process.