Managing Incidental Findings in Human Subjects Research

描述（由申请人提供）：这个为期2年的项目解决了一个非常重要但被广泛忽视的问题：研究人员应该如何处理具有潜在临床意义的偶然发现，知情同意书对此应该说些什么，以及IRB在审查方案时应该如何考虑偶然发现的可能性。我们所说的“偶然发现”并不是指研究中关键感兴趣的变量的结果，而是指超出重点研究兴趣领域的意外发现，例如功能性核磁共振成像（fMRI）研究中发现的可疑肿块，或偶然发现非亲子关系在家庭遗传研究中。 我们将通过关注以下4个研究领域的偶然发现来锚我们的分析：（1）功能磁共振成像研究，（2）CT结肠成像研究，（3）家族遗传学研究，（4）基因组微阵列研究。该项目将包括规范和经验两个部分。规范性工作将侧重于制定一份关于研究者和IRB应如何管理偶然发现的共识文件，以及知情同意书的范本语言。这将通过收集和分析美国研究人员在4个研究领域中使用的同意书和同意书范本来了解，这些同意书张贴在大学、专业协会和政府网站以及万维网上。该项目将由明尼苏达大学健康，环境和生命科学法律和价值观联盟的研究人员领导，与内容分析方面的高级专家和著名国家学者工作组合作。项目成果将包括：出版了共识建议和同意书语言范本，召开了一次会议，介绍我们的结论以及关于4个目标研究领域的附带发现管理的论文，并分析了附带发现的法律的影响，在一份收集这些论文的著名期刊上发表了一次专题讨论会，并建立了一个网站，提供诸如同意书语言范本和带网络链接的注释书目等工具。

DESCRIPTION (provided by applicant): This 2-year project tackles a profoundly important but widely ignored problem: how should researchers handle incidental findings that have potential clinical significance, what should consent forms say about this, and how should IRBs consider the potential for incidental findings in their review of protocols. By "incidental findings" we do not mean results on those variables of key interest in the research, but unexpected findings beyond the domain of focal research interest, such as a suspicious mass revealed in a functional MRI (fMRI) study, or an incidental finding of nonpaternity in genetic research on families. We will anchor our analysis by focusing on incidental findings in 4 research areas: (1) fMRI research, (2) CT colonography research, (3) genetic research on families, and (4) genomic microarray research. This project will have a normative and an empirical component. The normative work will focus on developing a consensus paper on how incidental findings should be managed by investigators and IRBs and model consent form language. This will be informed by collection and analysis of model consent forms and consent forms used by U.S. researchers in the 4 areas of study as posted on university, professional society, and governmental websites and on the World Wide Web. This project will be led by researchers in the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, collaborating with a senior empiricist expert in content analysis and a Working Group of prominent national scholars. Project outcomes will include: publication of the consensus recommendations and model consent form language, a conference presenting our conclusions plus papers on incidental findings management in the 4 targeted research areas and analysis of the legal implications of incidental findings, a published symposium in a prominent journal collecting these papers, and a website offering tools such as model consent form language and an annotated bibliography with web links.