Law, Policy, and Ethics Core

法律、政策和道德核心

• 批准号: 7649775
• 负责人: Victoria V Sutton
• 金额: $ 7.76万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7649775
• 关键词: Animal Testing; Animals; Area; Categories; Cities; Constitutional; Development; Diagnostic; Disease Outbreaks; Emergency Situation; Endemic Diseases; Equilibrium; Ethics; Event; Federal Government; Freedom; Funding; Goals; Individual; Infectious Diseases Research; Injury compensation; Institution; Instruction; Intellectual Property; International; International Aspects; Laboratories; Laws; Legal; Manufacturer Name; Marketing; Medical; Methods; Pharmaceutical Preparations; Policies; Policy Analysis; Primates; Process; Program Development; Public Health; Publications; Regulation; Relative (related person); Research; Research Personnel; Resources; Role; Safety; Scientist; Speech; Testing; Therapeutic; United States; Vaccines; Work; biodefense; biosecurity; human subject; interest; nonhuman primate; research and development; research study; restraint

PROJECT SUMMARY (See instructions): The Law, Policy, and Ethics Core (LPEC) provides support for the Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research (WRCE) through research, study, and analysis of policy, laws, and regulations which impact research and scientists in biodefense. Areas of focus for the LPEC include federal policy, law, and regulations; and international aspects of: (1) select agents, (2) dual use issues in scientific publications, (3) animal and primate testing, (4) vaccine and approval processes, (5) human subject testing, and (6) intellectual property. These areas support the WRCE scientific program development of therapeutics, diagnostics, and vaccines for Category A-C agents, and can potentially support the work of biodefense researchers in all Centers of Excellence in crosscutting areas of interest in law, policy, and ethics. A function of the LPEC is to evaluate questions regarding policy, law, and ethics that may be raised during the course of the work of WRCE investigators. The analysis and work of the core will involve the partners' participation in discussions of law, policy, and ethics relative to the areas of focus of the LPEC. Through open dialogue and discussion, the LPE Core will strive to impact policy and regulations in a manner conducive to furthering the research goals of the RCE scientists.

项目总结(见说明)： 法律、政策和道德核心(LPEC)为西部地区卓越中心提供支持 生物防御和新发传染病研究(WRCE)通过调查、研究和分析 影响生物防御研究和科学家的政策、法律和法规。重点关注的领域 LPEC包括联邦政策、法律和法规；以及国际方面：(1)选择代理人，(2)双重代理 在科学出版物中使用问题，(3)动物和灵长类动物试验，(4)疫苗和批准程序，(5) 人体试验，以及(6)知识产权。这些领域支持WRCE科学计划 为A-C类药物开发治疗学、诊断学和疫苗，并可能支持 所有英才中心的生物防御研究人员在法律相关交叉领域的工作， 政策和道德。 LPEC的一项职能是评估有关政策、法律和道德的问题，这些问题可能在 WRCE调查人员的工作过程。核心的分析和工作将涉及合作伙伴的 参与与LPEC重点领域相关的法律、政策和道德方面的讨论。穿过 公开对话和讨论，LPE核心将努力以一种方式影响政策和法规 有利于推进RCE科学家的研究目标。