Challenges of Informed Consent in Return of Data from Genomic Research

描述（由申请人提供）：基因组数据，包括研究目的附带的发现，可以包含与研究对象的健康、生活方式和生殖选择有关的有用和重要的信息。越来越多的专家组一致认为，至少基因组研究的一些信息应该提供给参与者。很明显，基因组研究结果的返回应该也将需要研究对象的知情同意。然而，在获得受试者有意义的同意方面，必须解决许多具有挑战性的问题，包括同意过程的内容，最大限度地减少扩大同意过程的不利后果，与生物样本有关的特殊问题，以及对儿童，决策障碍者和已故受试者的考虑。本研究的目的是：1)基于对规范和实证文献的分析回顾，制定一系列潜在的方法，以应对在广泛努力返回基因组数据之前必须解决的关于知情同意的关键挑战；2)通过一系列半结构化访谈和调查，了解基因组研究者和研究对象对这些问题的看法、解决这些问题的建议以及他们对菜单选项的看法；3)制定一系列讨论文件，概述挑战，考虑应对方案，为解决这些挑战的现实方法提供建议，并提出与政策相关的研究议程。为了应对知情同意的复杂挑战，研究团队将采用分析和实证相结合的策略。基于对现有文献的分析，我们将在常见的基因组研究情况下制定同意的替代方法菜单。针对这些情况的选项菜单将构成对基因组研究人员和研究对象进行半结构化访谈和基于互联网的调查的基础，以确定备选方法的可能优点和缺点。将这些数据与以前编制的备选方案分析结合起来，将确定切合实际的备选方案。当规范性论证和经验证据都不允许对最理想的选择得出合理的结论时，将提供有关进一步规范和经验调查的建议。研究结果将体现在一组三份讨论文件中，由基因组研究和生物伦理学专家进行审查。在纳入他们的反馈后，这些论文将在互联网上提供，提交到医学和生物伦理学文献中发表，并在相关的专业会议上发表。

DESCRIPTION (provided by applicant): 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, decisional 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. PUBLIC HEALTH RELEVANCE: Genomic data can contain information of use and importance to research subjects related to their health, lifestyle, and reproductive choices. Although there is a growing consensus that at least some information from genomic studies should be available to participants, there are a number of challenges to obtaining informed consent from research subjects for that purpose. This study is aimed at elucidating those challenges, identifying options for dealing with them, obtaining feedback from key stakeholders about those options, and formulating recommendations for the field as to how challenges to meaningful informed consent can be met.