Addressing Ethical Challenges in Networked Biorepositories

项目摘要/摘要 全国各地的各个机构都在努力支持各种领域的研究，包括 通过开发由生物样本和健康数据组成的大型生物库，进行精准医学研究 收集自当地患者和对照。然而，这些地方队列很少提供多样性和规模 需要识别和研究具有相同疾病生物机制的患者亚群，并且 因此，对相同的靶向治疗更有可能产生反应。为了解决这一需求，研究人员已经开始 促进多个机构内部或跨多个机构的多个储存库联网。这是一种网络化 生物存储库方法使研究人员能够访问更大、更多样化的数据集 以一种利用当地机构与他们自己建立的研究关系的方式 捐赠者社区。为了使这种方法取得成功，联网的生物信息库需要解决 重大的道德、法律和社会挑战。联网的生物信息库由不同的集合组成 来自不同机构的样本和数据，每个机构都有自己的治理结构和捐助者的需求。 出于这些原因，他们遇到了与同意和捐赠者许可、隐私和数据有关的复杂问题 安全性和数据访问。这些新的挑战以前没有被详细研究过，最好的 缺乏通过治理和监督进程解决这些问题的做法。这项研究将 通过对观点和经验进行严格的混合方法研究来满足这些重要需求 当前参与设计、运营和管理网络生物资源库的利益相关者。它还将 旨在制定同意和捐赠者许可、隐私和数据安全、数据访问、 最适合各种联网生物存储库的治理和监督 配置。

PROJECT SUMMARY/ABSTRACT Individual institutions across the country have worked to support research in a wide variety of areas, including precision medicine research, by developing large biorepositories comprised of biospecimens and health data collected from local patients and controls. However, these local cohorts rarely provide the diversity and size needed to identify and study subsets of patients who share biological mechanisms for their disease, and are thus more likely to respond to the same targeted therapies. To address this need, researchers have begun to promote the networking of multiple repositories within or across multiple institutions. This networked biorepository approach makes it possible for researchers to access larger, more diverse sets of data and biospecimens in a way that leverages the research relationships that local institutions have built with their own communities of donors. In order for this approach to be successful, networked biorepositories need to address important ethical, legal, and social challenges. Networked biorepositories are comprised of diverse sets of specimens and data from different institutions, each with their own governance structures and donor needs. For these reasons, they encounter complex issues related to consent and donor permission, privacy and data security, and data access. These novel challenges have not previously been examined in detail, and best practices for addressing these issues through governance and oversight processes are lacking. This study will address these important needs through a rigorous, mixed-methods study of the perspectives and experiences of stakeholders currently engaged in designing, operating, and governing networked biorepositories. It will also aim to develop approaches to consent and donor permission, privacy and data security, data access, governance, and oversight that are most appropriate and effective for a variety of networked biorepository configurations.