AI-Generated Synthetic Data Bypasses Ethics Reviews in Medical Research
2025-09-12

Medical researchers in Canada, the US, and Italy are using AI-generated synthetic data derived from real patient information in their experiments without ethics board approval. Institutions argue that since the synthetic data doesn't contain traceable patient information, it doesn't constitute human subject research under regulations like the US Common Rule. While accessing patient data to create the synthetic datasets requires ethics board approval, this is often waived due to low risk. This approach aims to protect patient privacy, accelerate research, and facilitate data sharing, but also raises ethical questions.
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