Genetic data partnerships: Enabling equitable access within academic/private data sharing agreements

项目摘要/摘要 候选人：Kayte Spector-Bagdady，JD，MBE，律师和医学伦理学家，专注于治理 利用人类标本和基因数据进行二次研究。她的长期职业目标是成为一名 独立调查员，负责开发、实施和翻译道德、法律、 和社会影响研究，以改进遗传数据共享治理。研究背景： 精准医学和基因研究的其他进展提供了改善诊断和治疗的机会 治疗数以百万计的患者。他们还需要获得大量的基因和相关健康 数据。联邦政府目前正在建设一个大型的、多样化的公共数据库，以使这项工作成为可能， 但目前最大的基因数据集是私人所有的，而且在规模和价值上都在以一定的速度增长 超过了公共同行。我们需要设计有效的遗传数据治理结构，使我们能够 调整激励和监管结构，以保护--但不是扼杀--遗传数据共享。为了做到这一点，我们 需要对推动遗传数据伙伴关系(GDP)市场的因素进行经验评估，从以下几个因素之一开始 最大的消费者：学者。研究目的：本研究的总体目标是描述和 评估影响学术GDPS的因素，将其与现有的治理结构进行比较，以及 为未来的最佳实践提供一个模型。这项研究的具体目的是：1)描述私人- 通过探索研究人员目前正在使用的资源、激励或 不鼓励使用公共数据和私有数据，以及这些选择的后果；2)开发和验证 测量这些因素以确定它们在选择数据集时的重要性的工具 私人数据与公共数据的优势/劣势，以及GDP协议的内容；以及3)评估 现有的治理结构和推动私人学术GDP市场的因素。研究计划：教授。 斯派克特将使用定性、定量和混合方法进行分析。在这个项目结束时，她 将产生一系列影响公私GDP市场的因素，开发和验证 衡量这些因素的工具，评估这些因素的患病率和 学术遗传学研究人员对目前私人-学术GDP治理方面的差距进行了分析， 并制定了一套最佳实践建议。职业发展计划：斯佩克特教授将发展 在基因科学、问卷设计和抽样以及混合方法方面的专长。她的训练将是 由经验丰富的和跨学科的导师提供支持；高级课程；参与研究 以及在强大的科学家、临床医生和健康社区内召开职业发展会议和研讨会 服务研究人员。这个项目将使斯佩克特教授成为一位思想领袖，建立一个公平的 基因数据共享治理系统，以改善未来患者的研究和临床护理。

PROJECT SUMMARY/ABSTRACT Candidate: Kayte Spector-Bagdady, JD, MBE, is an attorney and medical ethicist focused on the governance of secondary research use of human specimens and genetic data. Her long-term career goal is to become an independent investigator leading the development, conduct, and translation of mixed methods ethical, legal, and social implications research into improved genetic data-sharing governance. Research Context: “Precision medicine” and other advances in genetic research offer opportunities to improve diagnosis and therapy for millions of patients. They also require access to massive amounts of genetic and related health data. The federal government is currently building a large, diverse, and public databank to enable such work, but the largest genetic datasets are currently privately owned—and growing in size and value at a rate outstripping public counterparts. We need to design effective genetic data governance structures to allow us to calibrate incentivization and regulation structures to protect—but not stifle—genetic data-sharing. To do so, we need empiric evaluation of the factors driving the genetic data partnership (GDP) market, beginning with one of the largest consumers: academics. Research Aims: The overall goal of this research is to characterize and evaluate factors influencing academic GDPs, compare them to current existing governance structures, and offer a model for best practice going forward. The study's specific aims are to: 1) Characterize private- academic GDPs by exploring what resources researchers are currently using, factors that motivate or discourage the use of public vs. private data, and the consequences of those choices; 2) Develop and validate an instrument to measure these factors to determine their importance in selecting a dataset, perceived strengths/ weaknesses of private vs. public data, and content of GDP agreements; and 3) Assess gaps in existing governance structures and factors driving the private-academic GDP market. Research Plan: Prof. Spector will use qualitative, quantitative, and mixed methods analyses. At the conclusion of this project, she will have generated a set of factors influencing the private-public GDP market, developed and validated an instrument to measure these factors, assessed prevalence rates of these factors and concerns across academic genetic researchers, performed an analysis of current gaps in private-academic GDP governance, and developed a set of best practice proposals. Career Development Plan: Prof. Spector will develop expertise in genetic science, questionnaire design and sampling, and mixed methods. Her training will be supported by experienced and interdisciplinary mentors; advanced coursework; and participation in research and career development meetings and seminars within a robust community of scientist, clinicians, and health service researchers. This project will enable Prof. Spector to become a thought leader in building an equitable genetic data-sharing governance system to improve both research and clinical care for future patients.