a2 Collective Coordinating Center Central IRB Option for AITC Pilot Awards

Rose Li And Associates, Inc., Bethesda MD

Investigators

Linked publications & trials

Abstract

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.