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

 描述(申请人提供)：精确医学是一种新兴的疾病治疗和预防方法，它考虑到每个人在基因、环境和生活方式方面的个体差异。美国国立卫生研究院最近发起了精准医学倡议(PMI)，以加快发现的步伐。尽管PMI最初专注于癌症，但最终将产生适用于一系列疾病的知识，包括传染病。大量的联邦和私人研究资金一直并将继续致力于基因组学和传染病的交叉领域的科学研究。同时， 需要高度重视利用基因组信息管理传染病可能产生的伦理、法律和社会影响(ELSI)--对个人、群体或更大的社会而言。我们的P20探索性计划拨款是第一个考虑这些ELSI问题的人。根据我们的P20，拟议的CEER题为“将‘精确医学’应用于传染病的ELSI问题(#GUIDE2P5)”，旨在从系统的角度审查将基因组学纳入一系列传染病的预防、暴发控制和治疗所面临的伦理、法律、社会、历史和政策问题。我们的跨学科研究计划围绕三个独立但相关的计划领域进行组织，每个计划领域都包括一个试点项目。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)让一系列利益攸关方参与确定和应对ELSI和政策问题；(2)分析已确定的ELSI问题；以及(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。在计划领域1(对研究的影响)，试点项目将解决研究艾滋病毒和丙型肝炎病毒在高危城市人群队列中传播的遗传变异的影响。在方案领域2，(对公共卫生政策的影响)，试点项目将分析“疫苗经济学”的进展对以下方面的作用和影响 告知以人口为基础的预防。在计划领域3(临床实践的影响)，试点项目将评估基因组学在MRSA和埃博拉等急性、高后果传染病的临床管理中的应用。我们还提出了一项强有力的职业发展计划，该计划建立在约翰·霍普金斯大学不同部门提供的教育计划的基础上。包括本科生公共健康和生物伦理学课程，公共卫生学院的课程包括与伯曼生物伦理学研究所合作的新的生物伦理学硕士课程，遗传咨询硕士课程，公共卫生硕士/法学博士课程，遗传流行病学博士课程和预防医学住院医师课程；医学院为医学史上的医学生和博士后研究员开设的课程。我们的研究和教育计划旨在告知和影响未来的研究议程-即使科学仍在发展-以便基因组应用于传染病的好处最大化，同时将对个人和人口的潜在伤害降至最低。

 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.