Ethical, Legal, and Social Implications (ELSI) Core: Providing guidance to protect participants

Project Summary: The Ethical, Legal, and Social Implications (ELSI) Core The ELSI Core will ensure the protection of participants, investigators, and staff in matters of privacy, safety, and legality by providing guidance on ELSI and policy issues. Qualified and experienced ELSI Core personnel will accomplish this goal by creating and managing a cross-cutting communication structure across the other 4 VCC Cores (Administrative, Biospecimen Collection, Biospecimen Analysis, & Data Analysis and Submission). A protection program structured in this way ensures wrap-around protections to safeguard study participants, investigators, and staff; a novel approach in contrast to the traditional participant-centric protections schemas. In addition, the ELSI Core will further existing, and innovate new, research compliance strategies by conducting concurrent, within-study evaluations of compliance activities. The ELSI Core will conduct objective internal audits and self-assessments to evaluate methods of compliance across all VCCs and their activities. Doing so will provide a novel opportunity to establish ideal compliance strategies specific to large, multi-center studies that characterize the human virome. A broader goal of this work will be to publicly disseminate open access tools to guide such compliance activities, which, to our knowledge, has not been done before. In collaboration with the Data & Submission Analysis Core, the ELSI Core will design and execute a scientifically and socially justified return of results initiative under the HVP. This initiative will contemporize return of results protocols by drawing upon prior study of return of results methods, and innovate new directions for such methods by empirically validating return strategies and methods most optimal to participants, investigators, and staff. Finally, the ELSI Core will establish an ELSI Rapid-Response Communication Model. This cross-cutting model will ensure multidirectional communication across the HVP, within VCCs, outwardly to participants, and internally for evaluation and measurement. The ELSI Rapid-Response Communication Model is based on a hub-and-spoke design, which is a framework reliant on a centralized primary hub that serves as a shared service and coordinating entity for the spokes. A hub-and-spoke model will prepare the ELSI Core to achieve a coordinated and synergistic communication model by identifying a clear strategic intent, an operational roadmap, and precise performance measurements. Within this Communication Model, the ELSI Core will establish a participant-specific channel. The goal of this channel is to amplify the participant voice throughout the lifecycle of the study. The Participant Communication Channel is structured to invite a synergetic exchange with participants on research matters specific to them. It will be multimodal with a variety of mediums, tools, and work products (e.g. website, webinars, educational materials, infographics, public-facing consent forms).