University of Minnesota, Minneapolis, Minnesota, USA.
Genet Med. 2012 Apr;14(4):355-7. doi: 10.1038/gim.2012.26.
In this introduction to a symposium on managing incidental findings (IFs) and individual research results (IRRs) in genomic research involving biobanks and archived datasets, the principal investigator of the underlying NIH-funded project discusses the roots, current state, and likely future of this debate. The roots lie in the recognition that research participants are not mere means to scientific progress, but vulnerable individuals. After key position papers on return of IFs and IRRs by investigators, the debate has now turned to the more complex question addressed in this symposium--how large-scale research using biobanks and archived datasets should approach IFs and IRRs. Where is the debate headed next? The answer lies in the history itself, a history of progress toward recognizing the humanity and informational needs of research participants. Increasingly, participants will be offered individual information. Limits will be set, to preserve the capacity to perform research and to protect participants from faulty information. And not all studies and biobanks will undertake individual return. It will take research and work to tailor return to serve participants’ needs and research realities. But debating return is the next step toward recognizing those who contribute specimens and data as partners in the research process.
在本次关于生物库和存档数据集基因组研究中偶然发现(IFs)和个体研究结果(IRRs)管理的专题研讨会介绍中,该 NIH 资助项目的主要研究者讨论了这场争论的根源、现状和可能的未来。这场争论的根源在于认识到研究参与者不仅仅是科学进步的手段,还是易受伤害的个体。在研究者关于偶然发现和个体研究结果的关键立场文件发表后,争论现在已经转向了本次研讨会中更复杂的问题——使用生物库和存档数据集的大规模研究应该如何处理偶然发现和个体研究结果。接下来的争论方向是什么?答案在于历史本身,即朝着认识研究参与者的人性和信息需求的方向取得进展的历史。越来越多的参与者将获得个人信息。为了保护研究能力和防止参与者受到错误信息的影响,将设定限制。并非所有研究和生物库都将进行个体回报。需要研究和工作来定制回报,以满足参与者的需求和研究现实。但是,关于回报的争论是朝着承认那些提供样本和数据的人作为研究过程中的合作伙伴迈出的下一步。