Artificial Intelligence in Human Subjects Research

On Tech Ethics with CITI Program

Covers the challenges that Institutional Review Board (IRB) members face when reviewing research protocols that involve artificial intelligence (AI), strategies for addressing those challenges, current events and trends that may impact human subjects research involving AI, and additional resources that you can utilize if you are involved in this space.

Our guest is Tamiko Eto, MS, CIP who manages research compliance at the Division of Research at Kaiser Permanente. Tamiko also serves on the AI Ethics Advisory Board for Northeastern University’s Institute of Experiential AI.

Additional Resources:

• HHS definitions of human subject and research: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102
• Nils Nilsson definition of AI: https://ai.stanford.edu/~nilsson/QAI/qai.pdf
• Joanna Bryson and Jeremy Wyatt definition of AI: http://www.cs.bath.ac.uk/~jjb/web/whatisai.html
• OHRP list of ethical codes and research standards: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html
• SACHRP considerations for IRB review of research involving AI: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-e-july-25-2022-letter/index.html
• FDA guidance: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
• OSTP blueprint for AI bill of rights: https://www.whitehouse.gov/ostp/ai-bill-of-rights/
• EU proposed AI Act: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206
• CITI Program AI content: https://about.citiprogram.org/course/technology-ethics-and-regulations/
• PRIM&R webinars: https://primr.org/online-learning/webinars
• IRB reviewer checklist and decision tree: https://etohconsulting.com/wp-content/uploads/2021/12/ai-hsr-irb-reviewer-checklist-with-decision-tree.pdf
• White paper on IRB review of AI HSR: https://techinhsr.com/2022/08/25/how-to-conduct-an-effective-irb-review-of-artificial-intelligence-human-subjec/