C09 - From Researcher to Sponsor Investigator: How to Work With Your Broader HRPP to Develop and Deploy Safe, Effective, and Ethical Artificial Intelligence (AI)

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The role of a research healthcare organization is changing. These institutions have traditionally been in the research space of innovation where industry would then take their ideas and commercialize the product. AI and Machine Learning (ML) are introducing a new paradigm in which research healthcare organizations are becoming the manufacturers while maintaining their leading role in research. Is your HRPP ready to take on this new responsibility? While the protection of human subjects who participate in AI/ML research is a paramount concern, the safety, effectiveness, and ethical deployment of that end product is entirely dependent upon how the AI/ML research is conducted. IRB efforts alone are not sufficient to address the complex and dynamic challenges posed by AI/ML. Therefore, as researchers begin to adopt a sponsor-investigator role, a holistic and collaborative approach that leverages the expertise and resources of the entire HRPP is needed. This session will introduce considerations for institutions to utilize their current resources, community, and broader HRPP in coming together in this collective effort to accelerate translation of healthcare software into clinical practice by developing and deploying safe, effective, and ethical AI in healthcare, starting with the IRB. Attendees are encouraged to bring their own documents for cross-institutional learning and collaboration. Session findings and outcomes will bed disseminated after the conference.