GUIDE: Genomic Uses in Infectious Diseases and Epidemics

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DESCRIPTION (provided by applicant): Genomic information offers the opportunity for "personalized prevention" in both clinical practice and public health settings. To date, such efforts have focused primarily on chronic diseases and their behavioral risk factors. We propose an exploratory CEER to study the ethical, legal, social and policy (ELSP) issues arising in the novel and timely context of infectious disease. The proposed P20, "GUIDE: Genomic Uses in Infectious Disease & Epidemics, would be the first to map this terrain, and prepare for a Center to analyze relevant ELSP issues and make policy recommendations for addressing them. During the planning phase we will gather multidisciplinary content experts at Johns Hopkins to achieve four specific aims: (SA1): Create an organizational infrastructure, consisting of a Working Group and various intra-institutional, governmental and community stakeholders who will engage in a multidisciplinary dialogical approach that is standard in bioethics, to identify ad address emerging issues in the application of genomics to infectious diseases. (SA2): Illuminate the ELSP implications of advances in genomics for two paradigmatic viral diseases: (a) pandemic flu as an acute infection, and (b) Hepatitis C as a chronic infection. Through key informant interviews, focus groups, and white papers on the legal and policy issues, we will highlight the utility and ELSP implications of genomics for prevention (vaccine development, safety and efficacy, distribution and allocation) and treatment (severity of infection, efficacy/response of potential therapies, side effects, allocation). (SA3): Document information dissemination and communication about genomics and infectious diseases in the scientific, public health and social media domains. (SA4): Develop a vision and plan for a Center of Excellence (P50) on the ELSP implications of advances in genomics for infectious diseases. In developing the comprehensive research and training programs for the P50, we will apply what we learn from our "case studies" to other infectious diseases that are transmitted from human-to-human (e.g., HIV, HPV, tuberculosis), and broaden our reach to include additional categories of infectious disease such as insect-borne (e.g., malaria, Dengue fever, Chagas disease) and, perhaps, food-borne infections.