Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight

纳米诊断和纳米治疗：建立研究道德和监督

• 批准号: 7818595
• 负责人: SUSAN M. WOLF
• 金额: $ 43.31万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7818595
• 关键词: Acute; Address; Advisory Committees; Archives; Area; Bibliography; Biocompatible Materials; Bioethics; Biological; Biological Phenomena; Biomedical Engineering; Biotechnology; Chemicals; Classification; Clinical Trials Data Monitoring Committees; Collaborations; Consent Forms; Critiques; Development; Devices; Diagnostic; Drug Delivery Systems; Emerging Technologies; Ensure; Environmental Impact; Ethical Issues; Ethics; Funding; Gene Delivery; Gene Transfer; Goals; Health; Health Food; Human; Human Subject Research; Image; In Vitro; Informed Consent; Laws; Literature; Maps; Mechanics; Medical Device; Medicine; Modeling; Nanotechnology; National Cancer Institute; Occupations; Office for Human Research Protections; Online Systems; Optics; Outcome; Paper; Participant; Pharmaceutical Preparations; Pharmacotherapy; Policies; Policy Analysis; Positioning Attribute; Process; Property; Publishing; Recombinant DNA; Recommendation; Research; Research Ethics; Research Ethics Committees; Research Personnel; Resources; Risk; Safety; Science; Societies; Tissue Engineering; Toxicology; Uncertainty; United States Food and Drug Administration; United States National Institutes of Health; Videotape; Work; animal data; authority; gene therapy; human subject; in vivo; member; nano; nanobiotechnology; nanodiagnostic; nanomaterials; nanomedicine; nanometer; nanoparticle; nanoscale; nanotherapeutic; nanovector; novel; outer surface lipoprotein; response; symposium; tool; vector; working group

DESCRIPTION (provided by applicant): This proposal on Nanodiagnostics and Nanotherapeutics:Building Research Ethics and Oversight responds to RFA-OD-009-0003, addressing Challenge Area "02: Bioethics" and Challenge Topic "Unique Ethical Issues Posed by Emerging Technologies," as set forth in 02-OD (OSP)-101. The ability to manipulate atoms and molecules at the nanoscale has catalyzed the emerging field of nanomedicine. While many biological phenomena occur at the nanoscale, "nanomedicine" denotes material fabricated at the scale of 1-100 nanometers (nm) to take advantage of novel properties (biological, optical, thermal, chemical, and mechanical) that manifest at the nanoscale. A focal area of development is nanodiagnostics and nanotherapeutics. These fields use nanotechnology to develop nanoscale tools for in vitro diagnostics, in vivo imaging agents, drugs and therapies, targeted drug delivery systems, nanoparticle and other nanoscale gene delivery vectors, biomaterials for enhanced tissue engineering, and multi-function medical devices. Nanomedicine poses enormous challenges for human subjects research and oversight particularly because the health, safety, and environmental impacts of nanomaterials are largely unknown and researchers are struggling to characterize these materials and develop adequate toxicology and assessment tools. Despite these unknowns, research on nanodiagnostics and nanotherapeutics is already being conducted with human participants. Institutional Review Boards (IRBs), Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs), funders such as the National Institutes of Health (NIH), and oversight authorities at NIH, the Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP) are already facing acute challenges posed by nanomedicine research, but without systematic guidance on how to address those challenges. Indeed, the FDA has already approved some nanomedical products for use in human beings. Work is urgently needed to address what substantive changes to the rules governing human subjects research and what procedural changes to research oversight are necessary. This 2-year project will examine current and emerging nanomedicine research on drugs, devices, and gene therapy in order to map the issues raised by nanodiagnostic and nanotherapeutic research and oversight and formulate much-needed guidance. We will collect and analyze existing guidance on human subjects research and oversight by the NIH, FDA, and OHRP in nanotherapeutics and nanodiagnostics as well as existing policy analysis. We will use that to inform normative work generating the first systematic recommendations to ensure adequate protections and oversight for human participants in nanomedicine research. This process will involve collaboration among Investigators and Working Group members who are directly involved in the science, medicine, policy, law, and ethics of nanotechnology. This project will have major impact by providing the first systematic and comprehensive guidance on the ethical conduct and oversight of human subjects research on nanotherapeutics and nanodiagnostics. Outcomes will be: (1) an assessment of publicly available documents indicating how researchers, IRBs, DMCs/DSMBs, NIH, FDA, OHRP, and relevant professional societies are currently approaching the ethics of human subjects nanomedicine research; (2) an assessment of how NIH (including the Office of Biotechnology Activities (OBA) and the Recombinant DNA Advisory Committee (RAC)), FDA, and OHRP are approaching the oversight of human subjects nanomedicine research; (3) the first comprehensive and systematic recommendations on the ethics and oversight of human subjects nanomedicine research, to be authored by the Investigators after critique by the Working Group; (4) additional individually authored papers by members of the Working Group; (5) a public conference with videotape archived for free public access; (6) a comprehensive bibliography; and (7) rich web-based resources. This proposed project will serve the goals of ARRA by creating 4 jobs and significantly augmenting a fifth to aid in retention of that job. This project brings together top experts on nanomedicine, biomedical engineering, law, policy, and bioethics to produce the first systematic and comprehensive recommendations on how to protect human participants in research on nanodiagnostics and nanotherapeutics, including drugs, devices, and gene therapy using nonviral nano- vectors. Research in these nano-fields is burgeoning, with research on human participants under way, but current research ethics and oversight have not yet adequately addressed key concerns including: difficulty predicting human response from animal data, uncertainty about how to assess risks, concerns about both participant and third-party safety both short-term and long-term, and challenges obtaining informed consent. The project group will use normative, empirical, and policy analysis to evaluate current approaches to nanomedicine research ethics and oversight, including at NIH, FDA, and OHRP, generating much-needed recommendations on ethics standards and oversight processes.

描述（由申请人提供）：关于纳米诊断学和纳米治疗学：建立研究伦理和监督的提案响应RFA-OD-009-0003，解决挑战领域“02：生物伦理学”和挑战主题“新兴技术带来的独特伦理问题”，如02-OD（OSP）-101所述。在纳米尺度上操纵原子和分子的能力已经催化了纳米医学的新兴领域。虽然许多生物现象发生在纳米级，但“纳米医学”表示在1-100纳米（nm）尺度下制造的材料，以利用在纳米级表现出的新特性（生物，光学，热学，化学和机械）。发展的重点领域是纳米诊断和纳米治疗。这些领域使用纳米技术开发用于体外诊断的纳米级工具、体内成像剂、药物和治疗、靶向药物递送系统、纳米颗粒和其他纳米级基因递送载体、用于增强组织工程的生物材料以及多功能医疗设备。纳米医学对人类受试者的研究和监督提出了巨大的挑战，特别是因为纳米材料的健康，安全和环境影响在很大程度上是未知的，研究人员正在努力描述这些材料并开发适当的毒理学和评估工具。尽管存在这些未知因素，但纳米诊断学和纳米治疗学的研究已经在人类参与者中进行。机构审查委员会（IRB），数据监测委员会（DMC）和数据安全监测委员会（DSMB），资助者如美国国立卫生研究院（NIH），以及NIH，食品和药物管理局（FDA）和人类研究保护办公室（OHRP）的监督机构已经面临纳米医学研究带来的严峻挑战，但没有关于如何应对这些挑战的系统指导。事实上，FDA已经批准了一些用于人类的纳米医疗产品。迫切需要开展工作，以解决对人类受试者研究规则进行哪些实质性修改以及对研究监督进行哪些程序性修改是必要的。这个为期2年的项目将研究当前和新兴的纳米医学研究药物，设备和基因治疗，以映射纳米诊断和纳米医学研究和监督提出的问题，并制定急需的指导。我们将收集和分析现有的关于人类受试者研究的指导，以及NIH，FDA和OHRP在纳米治疗和纳米诊断方面的监督，以及现有的政策分析。我们将利用这一点为规范性工作提供信息，从而产生第一个系统性建议，以确保对纳米医学研究中的人类参与者进行充分的保护和监督。这一过程将涉及直接参与纳米技术的科学、医学、政策、法律和伦理的研究人员和工作组成员之间的合作。该项目将产生重大影响，为纳米治疗和纳米诊断学研究的人类受试者的道德行为和监督提供第一个系统和全面的指导。成果将是：（1）评估公开可用的文件，表明研究人员，IRB，DMC/DSMB，NIH，FDA，OHRP和相关专业协会目前如何接近人类受试者纳米医学研究的伦理;（2）评估NIH如何（包括生物技术活动办公室（OBA）和重组DNA咨询委员会（RAC）），FDA，和OHRP正在接近人类受试者纳米医学研究的监督;（3）关于人类受试者纳米医学研究的伦理和监督的第一个全面和系统的建议，将由研究者在工作组批评后撰写;（4）工作组成员个人撰写的其他论文;（5）一次公开会议，录像带存档供公众免费查阅;（6）全面的参考书目;（7）丰富的网上资源。这个拟议的项目将通过创造4个就业机会和显着增加五分之一，以帮助保留该工作的ARRA的目标。该项目汇集了纳米医学，生物医学工程，法律，政策和生物伦理学方面的顶级专家，就如何保护纳米诊断和纳米治疗研究的人类参与者提出了第一个系统和全面的建议，包括药物，设备和使用非病毒纳米载体的基因治疗。这些纳米领域的研究正在蓬勃发展，对人类参与者的研究正在进行中，但目前的研究伦理和监督尚未充分解决关键问题，包括：难以从动物数据预测人类反应，如何评估风险的不确定性，对参与者和第三方安全的担忧短期和长期，以及获得知情同意的挑战。该项目组将使用规范，经验和政策分析来评估当前的纳米医学研究伦理和监督方法，包括NIH，FDA和OHRP，产生急需的道德标准和监督过程的建议。