WCG, a provider of solutions that improve and accelerate clinical research, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) have partnered to lead a multi-stakeholder task force to address ethical and regulatory challenges in the Institutional Review Board (IRB) review of clinical research protocols that use artificial intelligence (AI).

The task force represents diverse stakeholders from across the clinical research ecosystem, including representatives from academic medical centers and universities, biotechnology and pharmaceutical companies, AI technology researchers, and IRB ethicists, members, and chairs. This multidisciplinary group’s collective insights aim to shape guidelines and resources addressing the layered ethical and practical implications of applying AI in clinical research.

The task force will evaluate AI’s use in various aspects of clinical trials, including protocol design, consent considerations, patient privacy and confidentiality, and participant recruitment. It will also evaluate AI when it is being studied as an investigational product for use in medical care. The task force aims 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.

“We are excited to partner with WCG to bring together a panel of multidisciplinary experts to examine the complexity that the use of AI in clinical research introduces,” said Barbara Bierer, MD, faculty director, MRCT Center. “Together, we will develop approaches, tools, and resources to guide IRB review that rely on strong ethical principles that prioritize participant safety and well-being. These resources will be made public and will be of use not only to IRB members but also to investigators, sponsors, and potential participants.”

In the coming months, the task force will review current use cases of AI in clinical trials, focusing on areas where there is a current lack of consistent review due to the novel nature of the technology. The group’s mandate is to develop clear, actionable guidelines that can be implemented by researchers and IRBs alike.

“Artificial intelligence has the potential to transform clinical research and improve health outcomes, but it also poses new and complex ethical challenges that require careful consideration and oversight,” stated Donna Snyder, MD, MBE, executive physician, WCG. “WCG’s vision is to enable the ethical and efficient use of AI in clinical research, while ensuring the protection of human dignity, autonomy, and welfare.”

The task force is expected to release its initial findings and recommendations early next year.