Ethics Review of Human Research Involving Artificial Intelligence (AI)
Artificial Intelligence (AI) refers to machine-based systems that learn from data and “learn” to perform tasks such as making predictions. Using algorithms and models, AI systems can process vast amounts of information to make recommendations or decisions that influence real or virtual environments. AI can be narrowly focused on completing a specific task but can also be purposed more generally, aiming to replicate human intelligence across multiple domains.

In 2024, the MRCT Center – in collaboration with WCG Clinical – convened a task force to address ethical and regulatory challenges in the IRB review of clinical research protocols involving AI. The task force includes representatives from academia, industry, AI technologists, and IRB ethicists, members, and chairs.

The task force will evaluate AI’s use in various aspects of clinical trials, including protocol design, consent considerations, patient safety, privacy and confidentiality, and participant recruitment. In addition, it will examine AI when it is being studied as an investigational product for use in medical care. The group’s mandate is to create guidelines and tools to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.
OBJECTIVES
- Define and analyze the current critical ethical and regulatory challenges when reviewing clinical research involving AI.
- Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, ethicists, and investigators to protect participants in research as AI’s role continues to grow.
- Identify new practical and actionable resources and tools needed by stakeholders.
KeY MILESTONES
- March 2024: Convened first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.
project Leadership & sTAFF
- Barbara Bierer, MD., Faculty Director, MRCT Center
- Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
- Trevor Baker, MS, Program Manager, MRCT Center