WCG, the global leader in providing solutions that measurably improve and accelerate clinical research, and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) are partnering 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.

As AI continues to play an increasingly important role in society and clinical research, the task force will evaluate its 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 is committed to being at the forefront of AI ethics, by collaborating with researchers, regulators, sponsors, and other stakeholders to ensure that AI is used in a responsible and trustworthy manner. 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. For more information about the project, please visit https://mrctcenter.org/project/ethics-ai/.

About The MRCT Center

The MRCT Center is a research and policy center created to address clinical trials' conduct, oversight, ethics, and regulatory environment, focusing on multisite, multinational trials. To do the work, we function as an independent convener to engage diverse stakeholders from industry, academia, patients and patient advocacy groups, nonprofit organizations, and regulatory agencies; we create multidisciplinary teams to identify challenges in the pre-competitive and to deliver ethical, actionable, and practical solutions for the global clinical trial enterprise. Since 2009, the MRCT Center’s efforts have implemented best practices, greater transparency, and improved research participant safety and engagement. The majority of our resources and tools are freely and openly available. With a history of convening workshops, conferences, and other forums for multistakeholder discussion, often of complex issues with representatives with competing interests, The MRCT Center is well positioned to help lead this effort.

About WCG

WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes, while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives. For more information, please visit wcgclinical.com or follow us on LinkedIn or X @WCGClinical.