Medical researchers at some institutions in Canada, the United States and Italy are using data created by artificial intelligence (AI) from real patient information in their experiments without the need for permission from their institutional ethics boards, Nature has learnt. To generate what is called synthetic data, researchers train generative AI models using real human medical information, then ask the models to create data sets with statistical properties that represent, but do not include, human data.

Typically, when research involves human data, an ethics board must review how studies affect participants’ rights, safety, dignity and well-being. However, institutions including the IRCCS Humanitas Research Hospital in Milan, Italy, the Children’s Hospital of Eastern Ontario (CHEO) in Ottawa and the Ottawa Hospital, and Washington University School of Medicine (WashU Medicine) in St. Louis, Missouri, have waived these requirements for research involving synthetic data.

Philip Payne, who is the university’s vice-chancellor for biomedical informatics and data science, and director of its Institute for Informatics, Data Science and Biostatistics, says that synthetic data sets are not considered "human-subject research" under the 1991 US federal Common Rule, which governs ethical standards for research involving people. This, he adds, is because the data don’t contain any real or traceable patient information.

Source https://www.nature.com/articles/d41586-025-02911-1

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