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

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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.