Enabling Responsible Public Genomics: An Interdisciplinary Seminar
Presented by Dan Vorhaus, JD, editor of the Genomics Law Report, ELSI advisor to the Personal Genome Project.
As scientific understandings of genetics advance, researchers require increasingly rich datasets that combine genomic data from large numbers of individuals with medical and other personal information. Linking individuals' genetic data and personal information precludes anonymity and produces medically significant information-a result not contemplated by the established legal and ethical conventions governing human genomic research. To pursue the next generation of human genomic research and commerce in a responsible fashion, scientists, lawyers, and regula-tors must address substantial new issues, including researchers' duties with respect to clinically significant data, the boundary between genomic research and commerce and the practice of medicine, and the challenges to privacy presented by genomic data.
Mr. Vorhaus presents a new model for understanding and addressing these new challenges, at its core a "public genomics" premised on the idea that ethically, legally, and socially responsible genomics research requires openness, not privacy, as its organizing principle. Responsible public genomics combines the data contributed by informed and fully consenting information altruists and the research potential of rich datasets in a genomic commons that is freely and globally available. He examines the risks and benefits of this public genomics model in the context of an ambitious genetic research project currently under way-the Personal Genome Project-and (i) demonstrates that large-scale genomic projects are desirable, (ii) evaluates the risks and chal-lenges presented by public genomics research, and (iii) determines that the current legal and regulatory regimes restrict beneficial and responsible scientific inquiry while failing to protect participants. He will conclude by proposing a modified normative and legal framework that em-braces and enables a future of responsible public genomics.