Human Virome Characterization Center for the Oral-Gut-Brain Axis

Ethical, Legal, and Social Implications Core: Abstract The Human Virome Program (HVP), which aims to broadly characterize the composition of the human virome across the lifespan in longitudinal, demographically diverse healthy human cohorts, has the potential to catalyze extraordinary progress to enhance our understanding of the virome’s role in human health and disease. Success of the HVP will rest, in part, on measures to identify and address the ethical, legal, and social implications (ELSI) of this endeavor, ensuring that the virome research enterprise is worthy of trust from both participants and the public and produces findings that are relevant and impactful. To support these efforts, we propose to establish the ELSI Core for the Human Virome Characterization Center for the Oral–Gut–Brain Axis. Led by Dr. Mary Majumder at Baylor College of Medicine (BCM), our group brings together a multi-institutional team with broad expertise studying the ELSI of biological and -omics research, including Dr. Amy McGuire (BCM), Dr. Nanibaa’ Garrison (University of California, Los Angeles), Dr. Jennifer Wagner (Penn State), Dr. Laura Weyrich (Penn State) and Dr. Janice Lee, Deputy Director for Intramural Clinical Research at the NIH National Institute of Dental and Craniofacial Research (NIDCR) and a member of the Multiple Principal Investigator (MPI) team on this U54 proposal. Our Core will address broad areas of ELSI concern, including the protection of participants, investigators, and NIH staff in matters of privacy, safety, and legality. We will also consider specific issues raised by this research, which include informed consent, data sharing (e.g., the potential for data shared publicly to disclose identifiable information about participants), return of results, and mitigation of individual and group harms (e.g., stigmatization and discrimination). We further note that although the inclusion of pediatric participants in our HVCC has important scientific benefits, pediatric participation can be associated with distinct ethical challenges, such as consideration of the limits of proxy consent or permission in relation to open-access data sharing and heightened concern about returning or withholding results that relate to adult-onset conditions. Our overall goal is to serve as a hub for all ELSI concerns arising in connection with the HVCC for the Oral– Gut–Brain Axis and provide an ELSI resource for the entire HVP Consortium through proactive engagement with other Cores, consortia, and constituencies. We will accomplish this goal by performing information gathering, legal and normative analyses, and resource development. Our work will have significant impact both within our HVCC and across the HVP by ensuring a multidisciplinary team of ELSI experts is proactively involved in identifying and addressing issues and challenges related to human virome research, data, and technologies. Our approach is innovative, involving the use of mixed methods to develop question-driven guidance and other resources for addressing ELSI concerns and multiple channels to share our findings with a variety of interested parties. The work is also feasible and will be efficient in our hands given that our team has extensive experience working with large consortia and research teams to address the ELSI of cutting-edge biomedical research.