What will potential research participants and the general public think of a project that seeks to characterize all the viruses inhabiting our bodies? While individuals may understand pathogenic viruses, few will relate to the idea of non-pathogenic, “good” viruses in and on our bodies. Over a decade ago, the NIH Human Microbiome Project (HMP) undertook a similar characterization of microbes living in and on humans. ELSI HMP studies employed conceptual analyses and empirical methods to explore how microbiome findings would 1) be understood by the public, 2) possibly alter their conceptions of health and disease; and 3) impact their views on research regulations. ELSI scholars and others also sought to identify and address concerns related to the HMP, such as commercialization, privacy, informed consent, return of results, intellectual property rights, diversity of subjects, justice concerns, and the use of the human microbiome in forensics. Most of these concerns are likely to apply to the Human Virome Program (HVP). For example, like the microbiome, the human virome is potentially identifiable (producing a “viral fingerprint”) and obtainable[CJ1] [HGE2] from skin samples. [KK3] The HVP is in early development, but anticipatory ELSI studies should address potential benefits and harms, including group-based harms; public perceptions of the HVP; implications of the HVP for understanding the meaning of “healthy” or “normal;” and appropriate governance policies for the HVP. We offer a systematic analysis of ELSI HMP research findings, develop a comparison of ELSI of the microbiome and virome, and offer recommendations for ELSI HVP work.
Authors: Gail E Henderson, University of North Carolina - Chapel Hill; R Jean Cadigan, University of North Carolina - Chapel Hill; Arlene M Davis, University of North Carolina - Chapel Hill; Kristine J Kuczynski, University of North Carolina - Chapel Hill; and Karen M Meagher, Mayo Clinic, Rochester MN
