ADVANCING COLLABORATIVE GENETIC RESEARCH: ETHICAL AND POLICY CHALLENGES

描述（由申请人提供）：学术健康中心（AHCs）在生物标本和相关数据（即生物银行）的收集、存储、使用和共享方面对人类受试者的保护政策将对国家通过多机构合作研究推进基因科学的能力产生重大影响。在获取生物标本和跨机构共享生物标本和/或数据的知情同意等核心问题上，政策的差异可能会阻碍或阻止合作研究。我们的初步数据表明，这种情况已经发生了。这些问题对于美国国立卫生研究院的临床和转化科学奖（CTSA）项目来说尤其及时，ahc被期望在该项目中作为一个联盟并在研究上进行合作。尽管它们很重要，但缺乏关于体制政策的系统信息，以及对AHC主要利益攸关方对这些问题的看法的理解。为了解决这些缺陷，我们建议：(1)确定CTSA机构在生物库中保护人类受试者的政策和实践的范围和变化——重点是知情同意和生物标本/数据共享；(2)威慑-确定CTSA机构的利益相关者群体（包括IRB主席，CTSA道德总监，调查员）对解决合作障碍的具体可行政策方案的态度；(3)通过跨学科的过程，分析构成知情同意和跨机构共享生物标本/数据集政策框架的伦理和监管问题，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、结构化问卷调查、半结构化访谈和既定共识发展过程来解决有关同意和生物标本/数据共享的具体政策问题。多学科研究团队优势互补。我们有一个杰出的专家咨询小组，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，它们还表明了机构间的重大政策差异，利益相关者认为这是合作的障碍。研究结果将广泛传播，包括：1)在学术期刊上发表基于经验和概念的分析；2)实用的政策建议（与咨询小组、CTSA利益相关者和其他权威机构共同制定），促进合乎伦理的、协作的、多机构的基因研究。我们相信这个项目会产生很大的影响。它直接解决了利用基因组信息改善人类健康这一最终目标取得进展的一个重要问题和障碍。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，其结果可能会影响临床和转化基因研究的概念和方法。

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. PUBLIC HEALTH RELEVANCE: Collaborative multi-institutional genetic research is pivotal to advancing genetic science, and often involves use of biospecimens contributed by human subjects and stored in repositories (biobanks) - but variation in institutions' policies for human subjects protection in biobanking can impede or prevent such research. This project will provide new knowledge on institutional policies and attitudes of key stakeholders, and will provide policy recommendations that facilitate ethically sound advancement of collaborative genetic research. The project therefore addresses an important problem and barrier to progress toward the goal of using genomic information to improve human health.