ADVANCING COLLABORATIVE GENETIC RESEARCH: ETHICAL AND POLICY CHALLENGES

描述(由申请人提供)：学术卫生中心(AHC)在生物标本和相关数据(即生物库)的收集、存储、使用和共享方面对人类受试者保护的政策将对该国通过多机构合作研究促进基因科学的能力产生重大影响。在核心问题上的政策差异，例如获得生物检疫的知情同意和跨机构共享生物检疫和/或数据，可能会阻碍或阻碍合作研究。我们的初步数据表明，这种情况已经在发生。这些问题对于NIH的临床和翻译科学奖(CTSA)计划来说尤其及时，在该计划中，AHC预计将作为一个联盟并在研究方面进行合作。尽管它们很重要，但缺乏关于体制政策的系统信息，也缺乏对AHC主要利益攸关方对这些问题的看法的了解。为了解决这些不足之处，我们建议：(1)界定CTSA机构在生物库中保护人类受试者的政策和做法的范围和差异--重点是知情同意和生物样本/数据共享；(2)阻止CTSA机构的利益攸关方群体(包括IRB主席、CTSA道德主任、调查人员)对解决合作障碍的具体可行政策选择的态度；以及(3)通过跨学科进程，分析制定关于知情同意和跨机构共享生物样本/数据集政策的伦理和监管问题，并制定一套政策建议。为了实现这些目标，我们将使用对书面政策的严格分析、带有结构化问卷的调查、半结构化访谈和既定的共识发展进程，以解决关于同意和生物检疫/数据共享的具体政策问题。我们的多学科研究团队优势互补。我们有一个优秀的专家咨询小组，并与CTSA机构建立了牢固的联系。初步数据有力地支持了我们计划的可行性；此外，它们表明各机构之间存在巨大的政策差异，利益攸关方认为这是合作的障碍。结果将被广泛传播，包括：1)在学术期刊上进行基于经验和概念的分析，2)(与咨询小组、CTSA利益攸关方和其他当局一起制定)实用的政策建议，以促进伦理健全、合作和多机构的遗传研究。我们相信这个项目将产生很大的影响。它直接解决了一个重要的问题和障碍，阻碍了实现利用基因组信息改善人类健康的最终目标。它直接响应ELSI优先事项和NIH路线图目标。此外，这些发现将提供知识，提高我们推进多机构研究的能力，结果可能会影响临床和翻译遗传学研究的概念和方法。

DESCRIPTION (provided by applicant): The policies of academic health centers (AHCs) for human subjects protection in the collection, storage, use, and sharing of biospecimens and associated data (i.e., biobanking) will have significant effects on the country's capacity to advance genetic science through collaborative multi-institutional research. Variation in policies for core issues such as informed consent to obtain biospecimens and sharing biospecimens and/or data across institutions can impede or prevent collaborative research. Our preliminary data suggest that this is already occurring. These issues are particularly timely for the NIH's Clinical and Translational Science Awards (CTSA) program, in which AHCs are expected to act as a consortium and collaborate on research. Despite their importance, systematic information on institutional policies is lacking, as is an understanding of the views of key AHC stakeholders about these issues. To address these deficiencies, we propose to: (1) Define the range and variation of policies and practices among CTSA institutions for human subjects protection in biobanking - with emphasis on informed consent and biospecimen/data sharing; (2) Deter- mine the attitudes of stakeholder groups at CTSA institutions (including IRB chairs, CTSA Ethics Directors, investigators) about specific feasible policy options to address barriers to collaboration; and (3) Analyze, through an interdisciplinary process, the ethical and regulatory issues that frame policies on informed consent and sharing biospecimens/datasets across institutions, as well as develop a set of policy recommendations. To accomplish these goals, we will use rigorous analyses of written policies, surveys with structured questionnaires, semi-structured interviews, and an established consensus development process to address specific policy issues on consent and biospecimen/data sharing. Our multidisciplinary research team has complementary strengths. We have an outstanding expert advisory group and robust linkages with CTSA institutions. The preliminary data strongly support the feasibility of our plans; moreover, they suggest substantial inter-institutional policy differences that stakeholders see as barriers to collaboration. The results will be disseminated broadly and include:1) empirically and conceptually based analyses in scholarly journals and 2) practical policy recommendations (developed with the advisory group, CTSA stakeholders, and other authorities) that facilitate ethically sound, collaborative, multi-institutional genetic research. We believe this project will have high impact. It directly addresses an important problem and barrier to progress toward the ultimate goal of using genomic information to improve human health. It responds directly to ELSI priorities and NIH roadmap goals. Moreover, the findings will provide knowledge that improves our capacity to advance multi-institutional studies, and the results are likely to influence concepts and methods in clinical and translational genetic research.