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

基本信息

批准号：
7944119
负责人：
SUSAN M. WOLF
金额：
$ 48.1万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7944119
关键词：
Acute Address Advisory Committees Archives Area Bibliography Biocompatible Materials Bioethics Biological Biological Phenomena Biomedical Engineering Biotechnology Chemicals 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

项目摘要

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.

这项关于纳米诊断和纳米治疗的提案：建立研究伦理和监督是对 RFA-OD-009-0003 的回应，解决了挑战领域“02：生物伦理”和挑战主题“新兴技术提出的独特伦理问题”，如 02-OD 中所述（OSP）-101。在纳米尺度上操纵原子和分子的能力催生了纳米医学的新兴领域。虽然许多生物现象发生在纳米尺度上，但“纳米医学”是指在 1-100 纳米 (nm) 尺度上制造的材料，以利用纳米尺度上表现的新特性（生物、光学、热、化学和机械）。发展的重点领域是纳米诊断和纳米治疗。这些领域利用纳米技术开发用于体外诊断的纳米级工具、体内成像剂、药物和疗法、靶向药物输送系统、纳米颗粒和其他纳米级基因输送载体、用于增强组织工程的生物材料以及多功能医疗设备。纳米医学给人类研究和监督带来了巨大的挑战，特别是因为纳米材料对健康、安全和环境的影响在很大程度上是未知的，研究人员正在努力表征这些材料并开发足够的毒理学和评估工具。尽管存在这些未知因素，纳米诊断和纳米治疗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)、美国国立卫生研究院 (NIH) 等资助者以及 NIH 的监督机构、食品和药物管理局 (FDA) 以及人类研究保护办公室 (OHRP) 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 已经批准了一些纳米医学产品用于人类。迫切需要解决对人类受试者研究规则进行哪些实质性改变以及对研究监督进行哪些程序性改变的必要性。这个为期两年的项目将审查当前和新兴的药物、设备和基因治疗方面的纳米医学研究，以便找出纳米诊断和纳米治疗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 NIH、FDA 和 OHRP 在纳米治疗和纳米诊断方面关于人类受试者研究和监督的现有指南以及现有政策分析。我们将利用它来为规范工作提供信息，生成第一个系统建议，以确保纳米医学研究中的人类参与者得到充分的保护和监督。这一过程将涉及直接参与纳米技术科学、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。该项目将通过为纳米治疗和纳米诊断人类受试者研究的道德行为和监督提供第一个系统和全面的指导而产生重大影响。结果将是：(1) 对公开文件进行评估，表明研究人员、IRB、DMC/DSMB、NIH、FDA、OHRP 和相关专业协会目前如何处理人类受试者纳米医学研究的伦理问题； (2) 评估 NIH（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 如何对人体纳米医学研究进行监督； (3) 第一个关于人体纳米医学研究的伦理和监督的全面、系统的建议，由研究人员在工作组批评后撰写； (4) 工作组成员单独撰写的其他论文；（五）公开会议，并存档录像供公众免费查阅；（六）综合参考书目； (7)丰富的网络资源。该拟议项目将通过创造 4 个就业岗位并显着增加 1/5 个就业岗位以帮助保留该就业岗位来实现 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尖专家，就如何保护纳米诊断和纳米治疗研究中的人类参与者（包括使用非病毒纳米的药物、设备和基因治疗）提出了第一个系统和全面的建议。 - 向量。这些纳米领域的研究正在蓬勃发展，针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：难以根据动物数据预测人类反应、如何评估风险的不确定性、对两者的担忧参与者和第三方的短期和长期安全，并挑战获得知情同意。该项目组将利用规范、实证和政策分析来评估当前纳米医学研究伦理和监督的方法，包括 NIH、FDA 和 OHRP，从而就伦理标准和监督流程提出急需的建议。