a2 Collective Coordinating Center Central IRB Option for AITC Pilot Awards

a2 集体协调中心 中央 IRB 选项 AITC 试点奖项

• 批准号: 10825366
• 负责人: Rose Maria Li
• 金额: $ 23.83万
• 依托单位: ROSE LI AND ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10825366
• 关键词: Academia; Acceleration; Aging; Alzheimer' s disease related dementia; American; Artificial Intelligence; Award; Caregivers; Caring; Collaborations; Communication; Communities; Complex; Contracts; Dedications; Dementia; Ensure; Ethics; Funding; Goals; Government; Government regulations; Health; Human Subject Research; Industry; Infrastructure; Institution; Institutional Review Boards; Leadership; Mission; Outcome; Persons; Pilot Projects; Principal Investigator; Process; Protocols documentation; Research; Standardization; Technology; Time; Translational Research; United States National Institutes of Health; Universities; Work; catalyst; collaboratory; expedited review; experience; healthy aging; human subject; improved; innovation; interest; parent grant; programs; research and development

Project Summary The Coordinating Center for the NIA Artificial Intelligence & Technology Collaboratories (AITC) for Aging Research undertakes a complementary set of activities to multiply the collective impact of the AITCs to improve care and health outcomes for older Americans, including persons with dementia (PWD) and their caregivers. The Specific Aims of the parent grant are to (1) Become a national hub and catalyst for AI and aging research and development by bringing together the worlds of academia, health, venture, industry, and government to ensure the successful translation of research to application; (2) create a culture of coordination, communication, and collaboration with the AITCs, NIA, and relevant NIA research centers and the broader scientific community; and (3) implement a robust national infrastructure to accomplish and evaluate the diverse and multifaceted responsibilities of the AITC Program. A core mission of the AITC program is to identify promising research beyond the traditional academic field via a national pilot awards competition. As AITC pilot awards are funded for no more than 12 months, it is critical to ensure timely project initiation to realize results and avoid the need for time extensions and additional administrative duties. In the first two national pilot awards competitions, the AITCs have received approximately 500 total applications, with 85% (GY2) to 91% (GY1) of finalists indicating involvement of human subjects which necessitates review by a responsible Institutional Review Board (IRB). About half of the finalists are nonacademic institutions, often start-ups, with very little or no experience complying with complex government regulations and without the institutional support to navigate the NIH and AITC’s university bureaucracy to proceed with alacrity. Due to this significant need for support in assembling necessary documents to satisfy IRB review, the AITCs have indicated strong interest for the Coordinating Center to establish a dedicated IRB specifically to help expedite the review of AITC pilot study protocols and, in turn, expedite the initiation of the pilot studies. AITCs have committed to work with their own institution’s IRBs to meet specific institutional requirements to cede oversight to a centralized contract IRB for non-exempt human subjects research, as needed. An AITC IRB hub would offer subawardees a supportive, efficient, and coordinated approach that complies with all government regulations, maintains high ethical standards, and accelerates research innovation. Centralized IRB assistance provided by the Coordinating Center can ensure that research is not impeded while harmonizing processes, utilizing a review board with expert-level understanding of the research goals of the AITCs, and creating efficiencies across the AITC institutions.

项目概要 NIA 老龄化人工智能与技术合作实验室 (AITC) 协调中心 研究开展一系列互补的活动，以扩大 AITC 的集体影响力， 改善美国老年人的护理和健康结果，包括痴呆症患者 (PWD) 及其家人 家长补助金的具体目标是 (1) 成为人工智能和人工智能的国家中心和催化剂。 通过汇集学术界、健康界、风险投资界、工业界和社会各界来进行老龄化研究和开发 政府确保研究成功转化为应用；（2）创造一种文化 与 AITC、NIA 和相关 NIA 研究中心进行协调、沟通和合作 更广泛的科学界；以及 (3) 建立强大的国家基础设施以实现和 评估 AITC 计划的多样化和多方面的责任。 AITC 计划的核心任务是发现传统学术领域之外有前途的研究 由于 AITC 试点奖项的资助期限不超过 12 个月，因此 对于确保及时启动项目以实现成果并避免延长时间至关重要 在前两次国家飞行员奖励竞赛中，AITC 获得了额外的行政职责。 总共约 500 份申请，其中 85%（第二年）至 91%（第一年）的入围者表示参与 大约一半的人类受试者需要由负责任的机构审查委员会（IRB）审查。 决赛入围者是非学术机构，通常是初创企业，很少或根本没有遵守 复杂的政府法规，并且没有机构支持来应对 NIH 和 AITC 的要求 由于集会需要大量支持，大学官僚机构迅速行动。 为了满足 IRB 审查的必要文件，AITC 对协调工作表现出了浓厚的兴趣 中心将设立专门的IRB，专门帮助加快AITC试点研究方案的审查 反过来，AITC 已承诺与自己合作，加快启动试点研究。 机构的 IRB 满足特定的机构要求，将监督权交给集中式合同 IRB 根据需要用于非豁免人类受试者研究。 AITC IRB 中心将为子获奖者提供支持、高效和协调的方法，该方法符合 遵守所有政府法规，保持高道德标准，并加速研究创新。 协调中心提供的集中IRB援助可以确保研究不受阻碍 在协调流程的同时，利用对研究目标具有专家级理解的审查委员会 的 AITC，并提高整个 AITC 机构的效率。