Ethical, legal, and social implications of the human virome

The National Institute of Allergy and Infectious Diseases (NIAID) awarded $427,625 to the University of North Carolina at Chapel Hill on July 24, 2025, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to support research addressing the ethical, legal, and social implications (ELSI) of human viromics research. The grant extends through June 30, 2027, and represents NIAID's commitment to integrating bioethics work with genomic research in infectious diseases. The project will deliver multidisciplinary analysis of ethical implications in the planning and conduct of viromics research, encompassing priority areas identified by NIAID and the National Human Genome Research Institute (NHGRI) regarding genetic and genomic research oversight.

The award funds three interlocking research aims with planned expansion to a full R01 proposal, including execution of a horizon scan examining unique ELSI challenges distinctive to viromics—such as concepts of viral colonization, regulatory pathways for bacteriophage research, and public uncertainty regarding complex genetic interactions among viruses, hosts, and vectors. Through its Office of Sponsored Research, UNC-CH will provide specialized bioethics expertise and policy analysis to support the expanding U.S. federal viromics research infrastructure, complementing concurrent investments by NIAID's U19 Genomic Centers for Infectious Diseases, the CDC's Pathogen Genomics Centers of Excellence, and the NIH Common Fund Human Virome Program.

Abstract

Advancing understanding of the human virome is a cross-institutional national priority. The national institute of allergy and infectious diseases (niaid) has a long-standing investment in U19 genomic centers for infectious diseases, renewed in april 2024 (RFA-AI-23-015). Meanwhile, the centers for disease control and prevention (CDC) recently funded 5 pathogen genomics centers of excellence to identify needs and opportunities for genomics in the U.S. Public health system (CDC 2023). Simultaneously, NIH's common fund human virome program will support projects that will comprehensively capture the role of viruses in the human body (RFA- RM-23-019). This investment trio reflects the enormous clinical and public health potential of expanding our understanding of human viruses, providing unexpected insights into individual and population health. Inevitably, viromics research teams will confront complex ethical, legal, and social implications (elsi) of this rapidly expanding area of science. In addition to standard concerns like risk, privacy, and broad consent, viromics might raise concerns distinctive to this area of science, including conceptions of the "human virome" and "viral colonization," gaps in regulatory pathway for bacteriophage research, or public uncertainty generated by complex genetic interactions among viruses, hosts, and vectors. In this R21, we propose to focus on priority areas from niaid and nhgri: (1) support the integration of bioethics work with genomic research in infectious diseases, analyzing ethical implications in the planning and conduct of niaid viromics research; and (2) significantly extend the focus of nhgri's elsi and policy issues that arise with the design and conduct of genetic and genomic research. Our project consists of three interlocking aims with a planned expansion to an R01 proposal. (1) we will undertake a multidisciplinary horizon scan based on an NIH-framework for governance of emerging technologies. This approach includes an expert filtration of the scientific literature to select 5 high-priority topics in virome research and associated elsi, comparing elsi of human genomics, microbiome, and virome. (2) findings from aim 1 will be developed into vignettes of virome research including potential clinical and public health applications (such as use of bacteriophages in clinical care and phylogenetics in hospital surveillance). Data will be collected from interviews with experts from a variety of disciplines and professions, including responses to and expansions on the 5 vignettes. (3) using results from aims 1 and 2, we will produce and disseminate vignette-based resource guides to be used by viromics teams and trainees as they encounter elsi. Resources will be disseminated through professional communities of practice and the elsihub, a platform that supports multidisciplinary resource sharing, including for lay audiences. In SUM, through conceptual and empirical analysis, and vignette development and dissemination, this project will advance elsi resources and illuminate elsi and policy implications that arise in human virome research.