GUIDE: Genomic Uses in Infectious Diseases and Epidemics

描述(由申请人提供)：基因组信息为临床实践和公共卫生环境中的“个人化预防”提供了机会。到目前为止，这些努力主要集中在慢性病及其行为风险因素上。我们提出了一个探索性的CEER来研究在新的和及时的传染病背景下出现的伦理、法律、社会和政策(ELSP)问题。拟议的P20“指南：基因组在传染病和流行病中的应用”将是第一个绘制这一领域的地图，并准备成立一个中心来分析相关的ELSP问题，并为解决这些问题提出政策建议。在规划阶段，我们将召集约翰·霍普金斯大学的多学科内容专家，以实现四个具体目标：(SA1)：创建一个组织基础设施，由一个工作组和各种机构内部、政府和社区利益攸关方组成，他们将参与生物伦理学中的标准多学科对话方法，以确定和解决在将基因组学应用于传染病方面出现的问题。(SA2)：阐明基因组学进展对两种典型病毒性疾病的ELSP影响：(A)作为急性感染的大流行性流感，和(B)作为慢性感染的丙型肝炎。通过关键的线人访谈、焦点小组和关于法律和政策问题的白皮书，我们将突出基因组学在预防(疫苗开发、安全性和有效性、分配和分配)和治疗(感染的严重程度、潜在疗法的疗效/反应、副作用、分配)方面的效用和ELSP影响。(SA3)：在科学、公共卫生和社交媒体领域传播和传播有关基因组学和传染病的文件信息。(SA4)：制定关于基因组学进步对传染病的ELSP影响的英才中心的愿景和计划(第50页)。在为P50制定全面的研究和培训计划时，我们将把我们从“案例研究”中学到的东西应用到其他从人与人之间传播的传染病(如艾滋病毒、人乳头瘤病毒、结核病)，并扩大我们的覆盖面，以包括其他种类的传染病，如虫媒传染病(如疟疾、登革热、恰加斯病)，或许还包括食源性传染病。

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.