Managing Incidental Findings in Human Subjects Research

管理人类受试者研究中的偶然发现

• 批准号: 7126441
• 负责人: SUSAN M. WOLF
• 金额: $ 28.69万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-26 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7126441
• 关键词: behavioral /social science research tag; clinical research; confidentiality; endoscopy; ethics; family genetics; functional magnetic resonance imaging; gastrointestinal imaging /visualization; health science research analysis /evaluation; human data; information retrieval; informed consent; microarray technology

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.

描述（由申请人提供）：这个为期 2 年的项目解决了一个极其重要但被广泛忽视的问题：研究人员应如何处理具有潜在临床意义的偶然发现，同意书对此应如何表述，以及 IRB 应如何考虑偶然发现的可能性他们对方案审查的结果。我们所说的“偶然发现”并不是指研究中关键关注变量的结果，而是指超出重点研究兴趣领域的意外发现，例如功能性 MRI (fMRI) 研究中发现的可疑肿块，或偶然发现家庭遗传研究中的非亲子关系。 我们将通过关注 4 个研究领域的偶然发现来进行分析：(1) 功能磁共振成像研究、(2) CT 结肠成像研究、(3) 家庭遗传研究和 (4) 基因组微阵列研究。该项目将包含规范部分和实证部分。规范性工作将侧重于制定一份共识文件，内容涉及研究者和 IRB 应如何管理偶然发现以及同意书语言模型。这将通过收集和分析在大学、专业协会、政府网站和万维网上发布的美国研究人员在 4 个研究领域使用的同意书范本和同意书来提供信息。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，与内容分析方面的资深经验主义专家和由著名国家学者组成的工作组合作。项目成果将包括：发表共识建议和样本同意书语言、召开会议，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以及对偶然发现的法律影响的分析、在著名期刊上发表的研讨会收集这些论文，以及一个提供工具的网站，例如模型同意书语言和带有网络链接的带注释的参考书目。