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（由适用提供）：精密医学是一种疾病治疗和预防的紧急方法，考虑到每个人的基因，环境和生活方式的个人变异性。 NIH最近发起了Precision Medicine Initiative（PMI），以加快发现的速度。尽管最初专注于癌症，但PMI最终将产生适用于一系列疾病（包括传染病）的知识。大量的联邦和私人研究资金已经并且将继续被部署到基因组学和传染病交集的科学研究中。并联， 对于个人，群体或更大的使用基因组信息的社会在传染病管理中，需要引起大量关注的道德，法律，社会含义（ELSI）（ELSI）。我们的P20探索性计划赠款是第一个考虑这些ELSI问题的人。拟议中的CEER题为“将“精密医学”应用于传染病（＃GUDE2P5）中的“ ELSI问题）”，旨在应用系统观点，以研究在预防，爆发，爆发控制和感染性疾病系列中基因组感染的道德，法律，社会，历史和政策问题。我们的跨学科研究计划是在三个离散但相关的计划领域左右组织的，每个计划包括1个试点项目。每个试点项目都将突出一种特定类型的感染疾病，并使用混合方法方法来（1）与一系列利益相关者识别和应对ELSI和政策问题； （2）分析已确定的ELSI问题，以及（3）有关在传染病管理中基因组信息整合的发展政策建议。在计划区域1（对研究的影响）中，试点项目将解决研究对艾滋病毒和HCV传播的遗传变异的影响。在计划区域2（对公共卫生政策的影响）中，试点项目将分析进步在“疫苗科学”中的作用和影响 告知基于人群的预防。在计划区域3（对临床实践的影响）中，试点项目将评估基因组学在急性，高后果感染等高MRSA和埃博拉病毒等临床管理中的应用。我们还提出了一项强大的职业发展计划，该计划基于约翰·霍普金斯（Johns Hopkins）不同部门可用的教育计划。其中包括的是本科公共卫生和生物伦理学计划，公共卫生学院计划包括与伯曼生物伦理学研究所，基因咨询硕士学位，MPH/JD计划，遗传流行病学博士学位和预防医学住所的新硕士课程；以及医学生和医学后研究员的医学学院计划。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，因此，基因组应用对传染病的好处被最大化，而对个人和人群的潜在危害也最小化。