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.

项目摘要 NIA人工智能与老龄化技术合作中心（AITC） 研究工作开展了一系列补充活动，以扩大AITC的集体影响， 改善美国老年人的护理和健康结果，包括痴呆症患者及其 照顾者父母补助金的具体目标是（1）成为人工智能的国家中心和催化剂， 老龄化研究和发展，汇集了学术界，健康，风险，工业， 政府应确保研究成果成功转化为应用成果;（2）创造一种 与AITC、NIA和相关NIA研究中心进行协调、沟通和合作， （3）建立健全的国家基础设施， 评估AITC计划的多样性和多方面的责任。 AITC计划的核心使命是确定传统学术领域之外有前途的研究 通过国家飞行员奖竞赛。由于AITC试点奖励的供资期限不超过12个月， 对于确保及时启动项目以实现成果和避免需要延长时间至关重要， 额外的行政职责。在前两届全国飞行员奖励竞赛中， 总共约500份申请，85%（GY 2）至91%（GY 1）的入围者表示参与了 需要由负责的机构审查委员会（IRB）审查的人类受试者。的一半左右 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，没有机构的支持，以浏览NIH和AITC的 大学官僚机构要迅速行动起来。由于在组装过程中需要大量的支撑， 满足IRB审查的必要文件，AITC对协调 中心建立专门的IRB，专门帮助加快AITC试点研究方案的审查 从而加快开展试点研究。AITC承诺与自己的 机构的IRB，以满足特定的机构要求，将监督权交给集中合同IRB 用于非豁免人类受试者研究。 AITC IRB中心将为次级获奖者提供支持，高效和协调的方法， 遵守所有政府法规，保持高道德标准，加速研究创新。 协调中心提供的集中IRB协助可确保研究不受阻碍 在协调过程的同时，利用对研究目标有专家级理解的审查委员会 AITC，并在AITC机构中提高效率。