Managing Incidental Findings in Human Subjects Research

描述(由申请人提供)：这个为期两年的项目解决了一个极其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，同意书应该如何说明这一点，以及IRBs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”并不是指关于研究中关键感兴趣变量的结果，而是超出焦点研究兴趣领域的意外发现，例如在功能磁共振成像(FMRI)研究中发现的可疑肿块，或在关于家庭的遗传学研究中偶然发现的非亲子关系。 我们将通过关注4个研究领域的偶然发现来锚定我们的分析：(1)功能磁共振研究，(2)CT结肠成像研究，(3)家系遗传研究，(4)基因组微阵列研究。该项目将包括规范性部分和经验性部分。规范性工作将侧重于就调查员和IRBs应如何管理附带调查结果和示范同意书语言编写一份协商一致的文件。这将通过收集和分析美国研究人员在大学、专业协会、政府网站和万维网上张贴的4个研究领域的样本同意书和同意书来了解情况。该项目将由明尼苏达大学健康、环境和生命科学中的法律和价值观联盟的研究人员领导，与内容分析方面的资深经验主义专家和由知名国家学者组成的工作组合作。项目成果将包括：发表共识建议和示范同意书语言，召开一次会议，介绍我们的结论以及关于4个目标研究领域的偶然发现管理的论文，并分析偶然发现的法律影响，在收集这些论文的著名期刊上发表专题讨论会，以及一个提供工具的网站，如示范同意书语言和带有网络链接的带注释的参考书目。

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.