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Challenges for Ethics Review Committees in Regulating Medical Artificial Intelligence Research Publisher



Esmaili A1 ; Rahmani A2 ; Alijanpour A3 ; Jayervand F4 ; Akhondzardaini R5 ; Sharifi MH6 ; Shams SE7 ; Rashvandi H8 ; Yeganegi M9 ; Shahbazi A10 ; Aghili K11 ; Neamatzadeh H12
Authors
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Authors Affiliations
  1. 1. Department of Emergency Medicine, School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  2. 2. Department of Plastic Surgery, School of Medicine, Iranshahr University of Medical Sciences, Iranshahr, Iran
  3. 3. Department of General Surgery, School of Medicine, Babol University of Medical Sciences, Babol, Iran
  4. 4. Department of Obstetrics and Gynecology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  5. 5. Student Research Committee, Department of Health Management, Policy and Economics, Faculty of Management and Medical Information Sciences, Kerman University of Medical Sciences, Kerman, Iran
  6. 6. Department of Cardiology, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
  7. 7. Department of Pediatrics, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
  8. 8. Student Research Committee, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
  9. 9. Department of Obstetrics and Gynecology, School of Medicine, Iranshahr University of Medical Sciences, Iranshahr, Iran
  10. 10. Student Research Committee, School of Medicine, Ilam University of Medical Sciences, Ilam, Iran
  11. 11. Department of Radiology, School of Medicine, Shahid Rahnamoun Hospital, ShahidSadoughi University of Medical Sciences, Yazd, Iran
  12. 12. Mother and Newborn Health Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

Source: Indian Journal of Surgical Oncology Published:2025


Abstract

The integration of artificial intelligence (AI) into medical research poses significant challenges for Ethics Review Committees (ERCs), especially concerning clinical trials and ethical assessments. This review identifies 23 primary challenges ERCs encounter in regulating medical AI, categorized into five sections that explore limitations faced by ERCs, researchers, and regulatory bodies, along with the complexities of rapidly advancing AI technologies. Key issues include the intricacies of AI systems, risks related to personal data re-identification, and the impact of multi-subject data on algorithm outputs. Ethical concerns about algorithmic bias, data ownership, and AI commercialization are also highlighted. The variation in regulatory frameworks across regions further complicates these challenges, highlighting the urgent need for revised guidelines tailored to AI research. The article stresses the necessity for interdisciplinary collaboration and ethics education for all stakeholders in AI, advocating for continuous reviews and enhanced engagement to ensure informed consent and address potential unintended consequences. Ultimately, it calls for the adaptation of ethical oversight mechanisms to support innovation while upholding ethical standards in the quickly evolving field of medical AI. © The Author(s), under exclusive licence to Indian Association of Surgical Oncology 2025.
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