Challenges of Informed Consent in Return of Data from Genomic Research

基因组研究数据返还时知情同意的挑战

基本信息

批准号：
8337275
负责人：
Paul Stuart Appelbaum
金额：
$ 20万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-23 至 2014-08-31
项目状态：
已结题

项目摘要

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.

项目概要基因组数据，包括与进行研究的目的相关的发现，可以包含对与健康、生活方式和生殖相关的研究对象的使用和重要性的信息选择。专家组日益达成的共识是，至少有一些来自基因组研究的信息应可供参与者使用。很明显，基因组研究的结果返回应该而且将会需要研究对象的知情同意。然而，存在许多具有挑战性的问题必须解决获得受试者有意义的同意的问题，包括同意的内容同意程序，最大限度地减少扩大同意程序带来的不利后果，特别与生物样本库样本有关的问题以及有关儿童、决策障碍的考虑因素人和已故的受试者。本研究的目的是： 1) 开发潜在的菜单应对知情同意方面必须解决的关键挑战的方法基于对规范和标准的分析审查，返回基因组数据的广泛努力已经到位实证文献； 2) 获取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，在一系列半结构化访谈和调查； 3) 制定一系列概述挑战的讨论文件，考虑应对方案，提出解决这些问题的现实方法建议挑战，并提出与政策相关的研究议程。应对信息灵通的复杂挑战同意后，研究团队将结合使用分析和实证策略。基于以下分析根据现有文献，我们将开发常见情况下同意的替代方法的菜单基因组研究情况。这些情况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，以确定替代方法可能的优点和缺点。将这些数据整合到先前对替代方案进行的分析将确定现实的选择。当既不规范论据和经验证据都无法对最理想的选择得出合理的结论，将就进一步的规范和实证研究提出建议。调查结果将具体化一组三篇讨论论文将由基因组研究和生物伦理学专家进行审查。后结合他们的反馈，这些论文将在互联网上提供，并提交在医学和生物伦理学文献，并在相关专业会议上发表。