In 2018 I presented at the Public Responsibility in Medicine &Research's (PRIM&R) Advancing Ethical Research (AER) conference and mentioned my Artificial Intelligence Human Subjects Research (AI HSR) Institutional Review Board (IRB) Reviewer Checklist. I've spent the last three years refining the checklist and feel that it is now finally suitable for use.
This checklist can be used for both medical and non-medical scenarios.
My colleagues and I have been working to explain a lot of these ethical and regulatory concepts (and how they are directly related to IRB responsibilities in the ethical oversight of AI HSR) at PRIM&R, CITI Program, and SACHRP via webinars and training modules.
The goal for this checklist is to be used freely, like a "template" to start with and adapt to your own institutional needs. Take what you want; leave the rest. It is intended to be used as a basis for further discussion. I'm very open to feedback on it to inform future iterations of the recommendations it contains. My aim is to help IRBs build their capacity as regulatory bodies responsible for protecting human subjects in research. In this checklist, I also include a decision tree for human subjects and exempt category four (4) (secondary use) determinations, based off the Office of Human Research Protections (OHRP) current guidance.
It is free and open to the public, so I made it extremely general. This is just the beginning of a broader dialogue about how and why IRBs can and should be involved in the ethical oversight of AI Human Subjects Research. In the checklist, I also add my HSR decision tree and Exempt determination decision tree. I can't wait to see how this evolves through the evolution of AI HSR in the IRB world! :)