Key Ethical Questions for Consideration and Research Practice Recommendations to Support Synthetic Data Research.

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 red...

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Publicado en:American Journal of Bioethics Vol. 26; no. 8; pp. 59 - 62
Autor principal: Hendricks-Sturrup, Rachele
Formato: commentary Journal Article
Publicado: Taylor & Francis Ltd Aug2026
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Taylor & Francis Ltd
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        atl: Key Ethical Questions for Consideration and Research Practice Recommendations to Support Synthetic Data Research.
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        au: Hendricks-Sturrup, Rachele
        affil: Duke University
      sug:
        subj:
          Artificial Intelligence Ethical Issues
          Data Science
          Research Ethics
          Clinical Trials
          Patient Selection
          Research Subject Recruitment
          Conceptual Framework
          Bioethics
          Data Quality
          Privacy and Confidentiality
          Study Design
          Decision Making
          Research Question
          Consent (Research)
      ab: 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.
      pubtype: Academic Journal
      doctype:
        commentary
        Journal Article
      ougenre: Article
    language: English
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