| Sumario: | The article focuses on ethical and practical considerations surrounding the use of artificial intelligence (AI)-generated synthetic data derived from real-world data (RWD) in clinical research, particularly in rare disease contexts. It highlights the potential benefits of synthetic data, such as reducing patient enrollment burdens and improving demographic representation, while emphasizing the importance of assessing and mitigating biases inherited from original RWD sets using tools like APPRAISE. The discussion raises unresolved ethical questions about informed consent, patient education, and institutional review board (IRB) oversight related to synthetic data generation and use, including the concept of opt-out consent. Additionally, the article underscores the role of AI-based applications in improving the readability and accessibility of informed consent documents and patient education, advocating for institutional guidance to support these efforts.
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