Ethical, Legal, Social Implication Core

ABSTRACT - Ethical, Legal and Social Implications Core The Human Virome Program (HVP) will build on its predecessors, the Human Genome Program (HGP) and the Human Microbiome Program (HMP), which also enrolled large and diverse cohorts of human participants and used DNA sequencing to characterize key aspects of human biology. Such deep characterization is critical for understanding and improving human health, but also might pose risks to individual participants, their communities, and researchers and funders involved in the work. Risks to participants potentially include i) harm from the procedures needed to obtain biospecimens, ii) loss of confidentiality or anonymity with resultant concerns about stigma, discrimination, and even legal risk, and iii) psychosocial or other harm from information discovered during the course of the research. Risks to the community can include stigma or discrimination that might result if certain genomic variants or a particular microbiome or virome signature is found to be more common in particular communities or minoritized groups. In addition, questions of consent, property rights in specimens and data, benefit-sharing with individuals and communities, and the ethics of commercialization pervade all -omics research. Despite the considerable work on ethical, legal and social issues done by HGP and HMP investigators, virome studies raise unique questions and areas of uncertainty remain. The Ethical, Legal and Social Implications Core (ELSI) of the Penn Virome Characterization Center will closely examine and evaluate these and other issues, provide advice and oversight to ensure ethical conduct of the proposed studies, and carry out original research to better understand possible implications of virome research and routes to optimizing benefit. To achieve these goals, we will: Aim 1. Advise and support the Penn VCC in the ethical and legal conduct of the science, ensuring respect for participants’ rights and interests, while contributing to the ELSI community and activities of the HVP Consortium. Aim 2. Identify current and emerging legal issues that arise in human virome research and compare them to issues arising in analogous genome and microbiome research in order to develop responsive policies and legal recommendations. Aim 3. Elicit the views of adult participants, parents of pediatric participants, and those declining participation regarding ethical, legal, and social issues arising in human virome research to inform the conduct of future research and appropriate protections and policies.