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“个性化预防”提供了机会。迄今为止，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研究的伦理，法律的，社会和政策（ELSP）的传染病的新的和及时的背景下出现的问题。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地形图，并准备建立一个中心，分析相关的ELSP问题，并提出解决这些问题的政策建议。在规划阶段，我们将在约翰霍普金斯聚集多学科内容专家，以实现四个具体目标：（SA 1）：创建一个组织基础设施，包括一个工作组和各种机构内，政府和社区利益相关者，他们将参与生物伦理标准的多学科对话方法，以确定和解决基因组学应用于传染病的新问题。(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。通过关键的知情人访谈，焦点小组，和法律的和政策问题的白色文件，我们将突出基因组学的预防（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，有效性/潜在疗法的反应，副作用，分配）的效用和ELSP的影响。(SA3)：记录科学、公共卫生和社交媒体领域有关基因组学和传染病的信息传播和交流。(SA4)：制定关于传染病基因组学进步对ELSP影响的卓越中心（P50）的愿景和计划。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”中学到的知识应用于其他人与人之间传播的传染病（例如，艾滋病毒、人乳头瘤病毒、结核病），并扩大我们的覆盖范围，以包括其他类别的传染病，如虫媒（例如，疟疾、登革热、恰加斯病），或许还有食源性感染。

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.