Ethical, Legal and Social Issues for Precision Medicine and Infectious Disease

 精准医学是一种新兴的疾病治疗和预防方法，考虑到每个人的基因、环境和生活方式的个体差异。NIH最近启动了精准医学计划（PMI），以加快发现的步伐。虽然最初的重点是癌症，但PMI最终将产生适用于包括传染病在内的一系列疾病的知识。大量的联邦和私人研究资金一直并将继续用于基因组学和传染病交叉领域的科学研究。同时， 在传染病管理中使用基因组信息对个人、群体或更大的社会可能产生的伦理、法律的、社会影响（ELSI）需要给予相当大的关注。我们的P20探索性规划补助金是第一个考虑这些ELSI问题的。借鉴我们的P20，拟议的CEER，题为“ELSI问题在应用'精准医学'传染病（#GUIDE2P5）"，旨在应用系统的角度来研究伦理，法律的，社会，历史和政策问题所面临的基因组学纳入预防，爆发控制和治疗一系列传染病。我们的跨学科研究计划围绕三个离散但相关的计划领域组织，每个领域包括一个试点项目。每个试点项目将突出一种特定类型的传染病，并使用混合方法来（1）让一系列利益相关者参与识别和应对ELSI和政策问题;（2）分析所识别的ELSI问题;（3）制定关于将基因组信息整合到传染病管理中的政策建议。在方案领域1（对研究的影响）中，试点项目将解决研究对高危城市人群中艾滋病毒和丙型肝炎病毒传播的遗传变异的影响。在计划领域2（对公共卫生政策的影响）中，试点项目将分析“疫苗组学”进步的作用和影响， 为基于人口的预防提供信息。在计划领域3（临床实践的意义）中，试点项目将评估基因组学在MRSA和埃博拉等急性高后果传染病临床管理中的应用。我们还提出了一个强大的职业发展计划，建立在约翰霍普金斯不同部门的教育计划。包括本科生公共卫生和生物伦理学课程，公共卫生课程包括与伯曼生物伦理学研究所合作的生物伦理学新硕士课程，遗传咨询硕士，MPH/JD课程，遗传流行病学博士课程和预防医学住院医师;以及医学生和博士后研究员的医学课程学校医学史。我们的研究和教育计划旨在告知和影响未来的研究领域，即使科学仍在发展，使基因组应用于传染病的好处最大化，同时对个人和人群的潜在危害最小化。

 DESCRIPTION (provided by applicant): Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. The Precision Medicine Initiative (PMI) was recently launched by the NIH to accelerate the pace of discovery. Though initially focused on cancer, the PMI will eventually generate knowledge applicable to a range of diseases, including infectious diseases. Substantial federal and private research funding has been, and will continue to be, devoted to scientific research at the intersection of genomics and infectious disease. In parallel, considerable attention needs to be paid to the possible ethical, legal, social implications (ELSI)-for individuals, groups or the larger society-of using genomic information in the management of infectious disease. Our P20 Exploratory Planning grant was the first to consider these ELSI questions. Drawing on our P20, the proposed CEER, entitled "ELSI Issues in Applying `Precision Medicine' to Infectious Disease (#GUIDE2P5)", aims to apply a systems perspective to examine the ethical, legal, social, historical and policy issues confronting the incorporation of genomics in the prevention, outbreak control, and treatment of a range of infectious diseases. Our transdisciplinary research plan is organized around three discrete but related program areas, each of which includes 1 pilot project. Each pilot project will highlight a particular type of infectious disease, and use a mixed-methods approach to (1) engage a range of stakeholders in identifying and responding to the ELSI and policy issues; (2) analyze the ELSI issues identified, and (3) develop policy recommendations regarding the integration of genomic information in infectious disease management. In Program Area 1 (Implications for Research), the pilot project will address the impact of research on genetic variation in HIV and HCV transmission in cohorts of at-risk urban populations. In Program Area 2, (Implications for Public Health Policy), the pilot project will analyze the role and impact of advances in "vaccinomics" for informing population-based prevention. In Program Area 3 (Implications for Clinical Practice), the pilot project will assess the application of genomics in the clinical management of acute, high consequence infectious diseases like MRSA and Ebola. We also propose a robust career development plan that builds on educational programs available in different Divisions of Johns Hopkins. Included are undergraduate public health and bioethics programs, School of Public Health programs including a new master's program in bioethics in partnership with the Berman Institute of Bioethics, Masters in genetic counseling, MPH/JD program, doctoral program in genetic epidemiology, and preventive medicine residency; and School of Medicine programs for medical students and post-doctoral fellows in the history of medicine. Our research and education plans are designed to inform and influence the future research agenda-even as the science is still developing-so that the benefits of genomic applications to infectious disease are maximized while potential harms to individuals and populations are minimized.