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A New Governance Approach to Regulating Human Genome Editing
John M Conley1, Arlene M Davis1, Gail E Henderson1
1John M. Conley is the William Rand Kenan, Junior Professor at the University of North Carolina School of Law, and the corresponding author for this Article.Arlene M. Davis is an Associate Professor of Social Medicine at the University of North Carolina School of Medicine. Gail E. Henderson is the Director of the Center for Genomic and Society, and a professor in in the Department of Social Medicine at the University of North Carolina School of Medicine. Eric T. Juengst is the Director of the Center for Bioethics, a Professor of Social Medicine, and a Professor of Genetics in the University of North Carolina School of Medicine. Karen M. Meagher is an Assistant Professor in the Biomedical Ethics Research Program at the Mayo Clinic. Rebecca L. Walker is a professor in the Department of Social Medicine, Department of Philosophy, and Center for Bioethics at the University of North Carolina at Chapel Hill. Margarete Waltz is a Research Assistant in the Department of Social Medicine at University of North Carolina School of Medicine. Jean Cadigan is an Associate Professor in the Department of Social Medicine, and a part of the core faculty at the Center for Bioethics at the University of North Carolina at Chapel Hill.
Genome editing technologies like CRISPR offer potential to fix gene mutations. International governance is crucial, with hybrid, multi-stakeholder models showing promise for ethical and practical considerations.
Area of Science:
- Genomic medicine and gene editing technologies.
- Bioethics and public policy in scientific advancement.
- International scientific governance and regulation.
Background:
- Genomic medicine, while promising, has had limited impact on daily practice.
- The goal of genomic medicine is to not only identify but also repair gene mutations.
- CRISPR and genome-editing technologies present potential solutions for repairing dangerous mutations.
Purpose of the Study:
- To identify and investigate practical, ethical, and policy considerations of human genome editing.
- To develop policy options for the governance of human genome editing.
- To monitor and analyze discussions and initiatives related to genome editing governance.
Main Methods:
- Multi-year, interdisciplinary project involving monitoring governmental and private groups.
- Observing scientific conferences and analyzing policy reports from national and international bodies.
- Interviewing diverse stakeholders, including scientists, ethicists, and policymakers.
Main Results:
- Identified prominent stakeholder concerns regarding human genome editing.
- Explored implications of these concerns for alternative governance models.
- Indicated that 'soft,' hybrid governance models involving multiple public and private stakeholders are promising.
Conclusions:
- Human genome editing necessitates urgent international governance discussions.
- Hybrid governance models, drawing from the 'new governance' paradigm, offer a practical path forward.
- Continued interdisciplinary research and stakeholder engagement are vital for effective policy development.
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