Artificial Intelligence (AI) and Ethical Research
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 established a project to explore the ethical considerations when using artificial intelligence (AI) in research. AI is rapidly being deployed across all aspects of research, including as the intervention itself and in the design, planning, and analysis stages. As with all research involving human participants, research with AI should be grounded in existing ethical principles and governing regulations to protect participants.
The MRCT Center, in collaboration with WCG Clinical, convened a task force to develop resources to address ethical and regulatory challenges during the IRB review of clinical research protocols involving AI. This collaborative project includes representatives from academia, industry, AI technologists, and IRB ethicists, members, and chairs to develop resources designed to assess research protocols and evaluate the risk-to-benefit ratio of AI deployed across various aspects of clinical trials, including informed consent considerations, patient safety, and data privacy and confidentiality.
The MRCT Center is also exploring the expanding uses of data and AI in support of clinical trials, particularly the increasing use of digital twins and synthetic data to create virtual simulations of patient outcomes and evaluate the technical, ethical, and practical considerations involved.
OBJECTIVES
- Identify and analyze key ethical and regulatory considerations in clinical research involving AI.
- Develop practical and actionable resources to strengthen the capacity of IRBs, ethicists, investigators, and sponsors to protect participants in research as AI is deployed in research.
- Convene multidisciplinary discussions through task forces, panels, and webinars to address emerging ethical issues.
- Explore and develop guidance on the responsible use of digital twins, synthetic data, and other AI-driven research innovations.
KeY MILESTONES
- November 2024: Organized a panel session during the MRCT Center’s Annual Symposium on the Expanding the Uses of Data and AI in Support of Clinical Trials, beginning the Digital Twins and Synthetic Data workstream.
- March 2024: Convened the first meeting of subject matter experts for the MRCT Center & WCG task force for the ethical review of research protocols involving AI.
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