The Association of Clinical Research Professionals

Responsible Oversight of Artificial Intelligence for Clinical Research Professionals

This special-edition white paper, published in January 2025, is written to assist the clinical research community in understanding the application and implications of artificial intelligence in a rapidly evolving landscape.

Across every industry, the adoption of artificial intelligence (AI) is increasing rapidly year after year. This growth and greater accessibility raise caution for its use in high-risk applications, such as in clinical research. Responsible oversight by clinical research professionals will be crucial, encompassing regulatory issues, organizational oversight, and professional standards.

“The clinical research community is poised for successful and responsible use of AI. Our unique blend of ethics, resiliency, flexibility, curiosity, and vision for a better future has made us successful not only in advancing clinical care, but also in advancing how we advance clinical care,” says David Vulcano, LCSW, MBA, CIP, RAC, FACRP, Vice President, Research Compliance & Integrity, HCA Healthcare, and author of this white paper.

PUBLICATION HIGHLIGHTS

  • Trends in General Oversight – The theme of emerging regulations governing the deployment and use of AI is reviewed—with examples of actual laws. The publication highlights common themes in oversight frameworks, addresses the paradigm shift AI brings in cybersecurity, and emphasizes the importance of stakeholder collaboration.

  • Research on AI as a Clinical Product – The application of existing medical device regulations to AI is explored. The white paper also covers laws, regulations, and ethics in relation to AI research when the definition of a medical device is not met. It concludes with privacy regulations, emphasizing the protection of personal data, especially in the context of secondary data use for training AI models.

  • AI-Enhancement to Research Processes – This section describes how AI is currently being used from lessons learned and is relevant to all clinical research professionals. It is supplemented in the appendix with more than three dozen real-world vignettes from use cases across various stages of the research process, drawn from published literature and unpublished cases provided for this publication.

  • The Impact on the Workforce and Our Profession – Much discussion remains on how AI will impact the clinical research workforce. While the future remains unknown, it seems certain that clinical research professionals who continuously update their knowledge on the benefits, limitations, risks, and implementation strategies of these AI tools will be best poised for success.

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CURATED RESOURCE CENTER

ACRP has launched an Artificial Intelligence Resource Center with commentaries on AI’s current impacts in the field and its potential future uses for improving efficiencies and effectiveness in clinical trials.

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