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，同意书应该对此说些什么，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”并不是指研究中那些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，如功能性磁共振成像（fMRI）研究中发现的可疑肿块，或在家庭遗传研究中偶然发现的非父系关系。

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.