This 3-year R01 based at the University of Minnesota and Vanderbilt University will convene a national Working Group of top legal and scientific experts to analyze current U.S. federal and state law, regulation, and guidance on translational genomics, and to generate consensus recommendations on what the law should be, to optimize successful translation of genomics into clinical use. The law underlying genomics is currently unclear, poorly understood, and contested. As this technology is now poised for wide clinical integration, legal scholars need to work with genomics experts to build the required legal foundation. Work is especially needed in 4 domains, the law of: Liability, Quality of sequencing and interpretation, Privacy & Access to genomic results, and the overarching Framework clarifying when research rules vs. clinical rules apply.
Aim 1 of this project is to build a searchable public online Database of state and federal statutes, regulation, case law, plus official guidance and standards, and an Annotated Bibliography of core literature-a map of what current genomics law is. The project will use established legal search methods and analysis to construct the Database, working with a professional web design firm to construct a highly functional, durable, and free public resource. We will use multiple search methods to build the Bibliography, posting it online for free access.
Aim 2 is to use mixed methods to ascertain stakeholder views of the law and generate rich inputs to inform a systematic Working Group process generating consensus recommendations on what the law undergirding translational genomics should be. Led by a senior social scientist, the team will use a modified Delphi method to elicit views of Working Group experts on issue priorities. To systematically capture a wide range of stakeholder views on issues and potential solutions, the project will use a streamlined survey and interview process. We will use an online REDCap(tm) survey to identify the perspectives of NIH-funded genomics investigators, legal counsel, industry representatives, genomics clinic directors, professional society leaders, and government authorities. We will also conduct semi-structured interviews with qualitative content analysis of the transcripts to capture more fully the views of a sample of legal counsel and government authorities. Informed by these rich inputs, the Working Group will pursue a structured process of analysis and consensus building that is well-established in law and bioethics. Each of 4 Task Forces will generate consensus recommendations, reporting to the full Working Group for feedback and project coordination. We will seek feedback on our recommendations from a subset of survey and interview respondents plus other expert readers, and through a major public conference. Project products will include: the online legal Database and Annotated Bibliography, 4 Task Force papers with consensus analysis and recommendations, individual targeted articles, published empirical analyses, a videotaped public conference, a symposium issue of a peer-reviewed journal presenting project publications, online access to our work, and wide dissemination.

Public Health Relevance

This innovative 3-year project based cooperatively at the University of Minnesota and Vanderbilt University will convene a national Working Group of top legal and scientific experts to analyze current U.S. federal and state law, regulation, and guidance on translational genomics and to generate consensus recommendations. The overarching goal is to build a solid legal foundation for successful integration of genomics into clinical use. The project team will build a searchable online database of relevant law and an annotated bibliography for free public access, systematically collect and analyze a range of stakeholder inputs, convene a national public conference, and publish extensive analyses and consensus recommendations to build the legal foundation for the future of genomic medicine.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
5R01HG008605-02
Application #
9291495
Study Section
Societal and Ethical Issues in Research Study Section (SEIR)
Program Officer
Mcewen, Jean
Project Start
2016-06-06
Project End
2019-05-31
Budget Start
2017-06-01
Budget End
2018-05-31
Support Year
2
Fiscal Year
2017
Total Cost
$722,764
Indirect Cost
$197,764
Name
University of Minnesota Twin Cities
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455
Evans, Barbara J (2018) HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights. Am J Hum Genet 102:5-10
Biros, Michelle (2018) Capacity, Vulnerability, and Informed Consent for Research. J Law Med Ethics 46:72-78
Lamkin, Matt; Elliott, Carl (2018) Avoiding Exploitation in Phase I Clinical Trials: More than (Un)Just Compensation. J Law Med Ethics 46:52-63
Evans, Barbara J (2018) Response to Dreyfus and Sobel. Am J Hum Genet 103:166-168
Wolf, Susan M; Evans, Barbara J (2018) Return of results and data to study participants. Science 362:159-160
Porter, Kathryn M; Kauffman, Tia L; Koenig, Barbara A et al. (2018) Approaches to carrier testing and results disclosure in translational genomics research: The clinical sequencing exploratory research consortium experience. Mol Genet Genomic Med 6:898-909
Wolf, Susan M; Scholtes, Emily; Koenig, Barbara A et al. (2018) Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants. J Law Med Ethics 46:87-109
Burke, Wylie; Beskow, Laura M; Trinidad, Susan Brown et al. (2018) Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance. J Law Med Ethics 46:79-86
Wolf, Susan M; Amendola, Laura M; Berg, Jonathan S et al. (2018) Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium. Genet Med 20:545-553
Vayena, Effy; Blasimme, Alessandro (2018) Health Research with Big Data: Time for Systemic Oversight. J Law Med Ethics 46:119-129

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