Artificial Intelligence in Human Subjects Research

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On Tech Ethics with CITI Program

Jan 24, 2023 Season 1 Episode 2

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/

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/

On Tech Ethics with CITI Program

Artificial Intelligence in Human Subjects Research

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