a2 Collective Coordinating Center Central IRB Option for AITC Pilot Awards

项目摘要 NIA人工智能与技术协作(AITC)老龄协调中心 研究开展一系列相辅相成的活动，以扩大AITCs的集体影响，以 改善美国老年人的护理和健康结果，包括痴呆症患者和他们的 照顾者。家长基金的具体目标是：(1)成为国家人工智能的枢纽和催化剂，以及 通过将学术界、卫生界、风险投资界、工业界和 政府确保成功地将研究转化为应用；(2)创造一种 与AITCS、NIA和相关的NIA研究中心以及 更广泛的科学界；以及(3)实施强有力的国家基础设施，以实现和 评估AITC计划的多样化和多方面的责任。 AITC计划的一个核心任务是确定传统学术领域以外的有前途的研究 通过一个全国性的飞行员奖项竞赛。由于AITC飞行员奖的资助期限不超过12个月，因此 确保及时启动项目以实现成果并避免需要延长时间和 额外的行政职责。在前两届国家飞行员奖竞赛中，AITC获得了 总计约500份申请，其中85%(Gy2)至91%(GY1)的决赛选手表示参与了 需要由负责任的机构审查委员会(IRB)审查的人类科目。大约一半的人 入围决赛的是非学术机构，通常是初创企业，几乎没有或没有遵守的经验 复杂的政府法规，缺乏机构支持来驾驭NIH和AITC 大学的官僚作风要干净利落地进行。由于在组装过程中对支撑的这种重大需求 为满足IRB审查所需的文件，AITC已表示对协调有强烈的兴趣 中心专门设立专门的内部审查委员会，以帮助加快AITC试点研究方案的审查 进而加快试点研究的启动。AITC已承诺与他们自己的 机构的内部评级机构应满足特定的机构要求，将监督权移交给一个中央合同内部评级机构 根据需要，用于非豁免的人体受试者研究。 AITC IRB中心将为获奖者提供支持性、高效和协调的方法，以符合 遵守所有政府法规，保持较高的道德标准，加快研究创新。 协调中心提供的集中IRB协助可确保研究不受阻碍 在协调进程的同时，利用一个对研究目标具有专家级了解的审查委员会 提高了AITC的效率，提高了AITC机构的效率。

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.