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

精准医学和传染病的伦理、法律和社会问题

• 批准号: 9111423
• 负责人: GAIL GELLER
• 金额: $ 101.6万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-05-16 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9111423
• 关键词: Accounting; Acute; Address; Area; Attention; Bioethics; Chronic Disease; Clinical Management; Common Good; Communicable Diseases; Communication; Communities; Coupled; Development Plans; Disease; Disease Management; Disease Outbreaks; Ebola virus; Ensure; Environment; Epidemic; Freedom; Funding; Genes; Genetic; Genetic Counseling; Genetic Variation; Genomics; Grant; HIV/HCV; Health; Health Policy; Hepatitis C; Hepatitis C Transmission; History of Medicine; Immunology; Individual; Infection; Infectious Disease Epidemiology; Infectious Diseases Research; Influenza C Virus; Information Technology; Institutes; Knowledge; Laws; Life Style; Malignant Neoplasms; Medical Students; Medicine; Methods; Pattern; Perception; Persons; Pilot Projects; Policies; Population; Postdoctoral Fellow; Precision Medicine Initiative; Predisposition; Prevention; Preventive Medicine; Public Health; Public Health Applications Research; Public Health Schools; Readiness; Recommendation; Recording of previous events; Research; Research Personnel; Residencies; Resistance; Risk; Role; Scholarship; Science; Social Policies; Social Sciences; Societies; System; Translations; United States National Institutes of Health; Universities; Urban Population; Variant; Vulnerable Populations; Work; burden of illness; career development; clinical care; clinical practice; cohort; design; disease transmission; disorder prevention; disparity reduction; education planning; ethical legal social implication; genetic epidemiology; infectious disease treatment; insight; medical schools; methicillin resistant Staphylococcus aureus; pandemic influenza; population based; precision medicine; programs; public health relevance; response; skills; social media; transmission process; vaccine safety; vaccinomics

 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.

 描述（由申请人提供）：精准医学是一种新兴的疾病治疗和预防方法，它考虑了每个人基因、环境和生活方式的个体差异。美国国立卫生研究院 (NIH) 最近发起了精准医学计划 (PMI)，以加快发现的步伐。虽然 PMI 最初专注于癌症，但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已经并将继续致力于基因组学和传染病交叉领域的科学研究。并联， 需要高度重视在传染病管理中使用基因组信息可能对个人、团体或更大的社会产生的伦理、法律、社会影响（ELSI）。我们的 P20 探索性规划拨款是第一个考虑这些 ELSI 问题的拨款。借鉴我们的 P20，拟议的 CEER 题为“将‘精准医学’应用于传染病中的 ELSI 问题 (#GUIDE2P5)”，旨在应用系统视角来审查将基因组学纳入预防、疫情控制和治疗一系列传染病所面临的伦理、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项目领域组织，每个领域包括 1 个试点项目。每个试点项目将重点关注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) 分析已发现的 ELSI 问题，(3) 制定有关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）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， 为基于人群的预防提供信息。在计划领域 3（对临床实践的影响）中，试点项目将评估基因组学在 MRSA 和埃博拉等急性、严重后果传染病的临床管理中的应用。我们还提出了一个强有力的职业发展计划，该计划以约翰·霍普金斯大学不同部门提供的教育计划为基础。包括本科公共卫生和生物伦理学课程、公共卫生学院课程（包括与伯曼生物伦理学研究所合作的新生物伦理学硕士课程）、遗传咨询硕士、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培训；医学院为医学生和医学史博士后研究员提供的课程。我们的研究和教育计划旨在为未来的研究议程提供信息和影响——即使科学仍在发展——以便基因组应用在传染病方面的益处最大化，同时对个人和群体的潜在危害最小化。