ELSI Core

Meaningful research in the Human Virome Program (HVP) will require the collection of vast amounts of information - a process that raises a host of novel ethical, legal, and social implications (ELSI). To address these challenges, we have assembled an ELSI Core for this Virome Characterization Center (VCC) that is multidisciplinary in its design, incorporating expertise in bioethics and law, public policy, informatics, and data privacy. We will support the VCC, as well as the HVP program more broadly, by providing guidance on ELSI issues to protect participants, investigators, and NIH staff in several ways. First, we will develop practices to ensure that HVP participants are sufficiently diverse and informed to provide meaningful consent. This project raises important issues regarding informed consent to meet the public’s growing expectations of transparency in research and regulatory requirements. We will need a consent process that addresses how to communicate return of HVP research results with all their complex implications and the extent to which privacy can be assured when data is shared beyond the VCC. To do so, we will build on our prior experience in other NIH consortia, which will be supplemented by a review of the literature and legal reporting requirements, to design an appropriate consent process. Second, we will characterize and work to mitigate the risks of misuse of HVP data. While certain laws aim to stem discrimination based on genetic predispositions, many states; however, are enacting genetic information and data privacy laws, some of which may have greater reach. We will monitor these issues closely through analysis of state legislative activity using tools such as Westlaw. We will also document trends in the public’s views, primarily by looking at published polls as well as newspapers and other media. Third, we will support the dissemination of data to the public in a privacy protective manner while providing participants with relevant research results. In this respect, we will work with the scientists involved in the HVP, as well as with community partners, to define criteria for which results should be returned. This may entail addressing the question of whether it would be ethically acceptable to return a subset of results related to viruses, and if so, how such limits would be defined and communicated, particularly for populations for which English may not be their primary language. We will also adapt and apply re-identification risk assessment methods and devise de- identification routines to make as much data available as possible. Finally, we will serve in a in a consultative role for ELSI for other VCC cores, the Consortium Organization and Data Collaboration Center (CODCC), and the HVP more broadly.