Challenges of Informed Consent in Return of Data from Genomic Research

项目摘要 基因组数据，包括与研究目的相关的发现，可以包含 与健康、生活方式和生殖有关的研究对象的用途和重要性信息 选择.越来越多的专家一致认为，至少有一些来自基因组研究的信息， 应提供给与会者。很明显，基因组研究结果的回报应该而且将会 需要研究对象的知情同意。然而，有一些具有挑战性的问题， 必须在获得受试者有意义的同意方面加以解决，包括 同意程序，最大限度地减少扩大同意程序的不利后果，特别是 与生物库样本有关的问题，以及对儿童、决策障碍者和 人，和死亡的主题。本研究的目的是：1）开发一个菜单的潜力 处理知情同意方面关键挑战的方法， 根据对规范性和可持续性的分析审查， 经验文献; 2）获得基因组研究者和研究对象对这些问题的看法 问题，他们解决这些问题的建议，以及他们对菜单选项的想法，在一系列的半- 结构化访谈和调查; 3）编写一系列讨论文件，概述挑战， 考虑应对方案，提出解决这些问题的现实方法建议 挑战，并提出一个与政策相关的研究议程。为了应对信息化的复杂挑战， 同意，研究小组将使用分析和实证策略相结合。通过分析 现有的文献，我们将开发菜单的替代方法，以同意在常见的发生 基因组研究的情况。这些情况下的选项菜单将构成半- 对基因组研究人员和研究对象进行结构化访谈和基于互联网的调查， 其他方法可能的优点和缺点。将这些数据整合到 根据先前制定的替代品分析，将确定现实的备选方案。当既不规范 无论是论证还是经验证据，都不能对最可取的选择得出似是而非的结论， 将就进一步的规范和经验调查提出建议。调查结果将体现在 在一套三个讨论文件，将审查专家在基因组研究和生物伦理学。后 这些论文将纳入他们的反馈意见，在互联网上提供，提交《世界报》发表。 医学和生物伦理学文献，并在相关专业会议上发表。

Project Summary Genomic data, including findings incidental to the purpose for which a study is undertaken, can contain information of use and importance to research subjects related to their health, lifestyle, and reproductive choices. A growing consensus of expert groups is that at least some information from genomic studies should be available to participants. It seems clear that return of results from genomic studies should and will require the informed consent of research subjects. However, there are a number of challenging issues that must be addressed with regard to obtaining meaningful consent from subjects, including the content of the consent process, minimizing adverse consequences from an expanded consent process, special issues relating to biobanked samples, and considerations regarding children, decisionally impaired persons, and deceased subjects. The aims of this study are: 1) To develop a menu of potential approaches for dealing with the key challenges regarding informed consent that must be addressed before widespread efforts to return genomic data are put into place, based on an analytic review of the normative and empirical literatures; 2) To obtain the perspectives of genomic investigators and research subjects on these issues, their suggestions for addressing them, and their thoughts about the menu options, in a series of semi- structured interviews and surveys; 3) To formulate a series of discussion papers that outline the challenges, consider the options for response, offer recommendations for realistic approaches to address these challenges, and suggest a policy-relevant research agenda. To address the complex challenges of informed consent, the research team will use a combination of analytic and empirical strategies. Based on an analysis of the existing literature, we will develop menus of alternative approaches to consent in commonly occurring genomic research situations. The menus of options for these situations will then form the basis for semi- structured interviews and internet-based surveys of genomic researchers and research subjects to identify the probable advantages and disadvantages of the alternative approaches. Integrating these data into the previously developed analysis of alternatives, realistic options will be identified. When neither normative argument nor empirical evidence allows plausible conclusions to be drawn about the most desirable options, suggestions will be offered regarding further normative and empirical investigation. Findings will be embodied in a set of three discussion papers that will be reviewed by experts in genomic research and bioethics. After incorporating their feedback, the papers will be made available on the internet, submitted for publication in the medical and bioethical literatures, and presented at relevant professional meetings.