PARTICIPANTS' RECALL AND UNDERSTANDING OF GENOMIC RESEARCH AND LARGE-SCALE DATA SHARING
PARTICIPANTS' RECALL AND UNDERSTANDING OF GENOMIC RESEARCH AND LARGE-SCALE DATA SHARING
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DOI：
10.1525/jer.2013.8.4.42
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发表时间：
2013-10-01
影响因子：
1.3
通讯作者：
McGuire, Amy L.
中科院分区：
文献类型：
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作者：
Robinson, Jill Oliver;Slashinski, Melody J.;McGuire, Amy L.
由于基因组研究人员被敦促与其他研究人员公开共享生成的序列数据，因此检查知情同意文件和流程的效用是很重要的，特别是因为这些文件和流程与参与者对提供给他们的信息的参与和回忆、他们对基因组研究关键要素的客观或主观理解（例如，数据共享）以及这些因素如何影响或调解他们做出的决定有关。我们进行了一项随机试验，包括三份实验性知情同意文件（ICDs），参与者（n = 229）被招募参加基因组研究；每一份文件都对基因信息发布的广度进行了不同程度的控制。在后续的结构化访谈中评估了回忆和理解，他们对数据共享决策的影响，以及决策的舒适度。超过25%的人不记得签署了参与基因组研究的ICD，大多数人（54%）不能正确识别他们同意与谁共享他们的基因组数据。然而，参与者认为他们已经足够了解，可以做出明智的决定，而且缺乏回忆并不影响最终的数据共享决定或参与满意度。这些发现提出了一些问题，即参与者需要哪些类型的信息才能提供有效的知情同意，以及主观的理解和对决策的舒适是否足以满足尊重人的道德原则。
AS GENOMIC RESEARCHERS ARE URGED to openly share generated sequence data with other researchers, it is important to examine the utility of informed consent documents and processes, particularly as these relate to participants' engagement with and recall of the information presented to them, their objective or subjective understanding of the key elements of genomic research (e.g., data sharing), as well as how these factors influence or mediate the decisions they make. We conducted a randomized trial of three experimental informed consent documents (ICDs) with participants (n = 229) being recruited to genomic research studies; each document afforded varying control over breadth of release of genetic information. Recall and understanding, their impact on data sharing decisions, and comfort in decision making were assessed in a follow-up structured interview Over 25% did not remember signing an ICD to participate in a genomic study, and the majority (54%) could not correctly identify with whom they had agreed to share their genomic data. However, participants felt that they understood enough to make an informed decision, and lack of recall did not impact final data sharing decisions or satisfaction with participation. These findings raise questions about the types of information participants need in order to provide valid informed consent, and whether subjective understanding and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons.