Jeyaraman Madhan, Jeyaraman Naveen, Ramasubramanian Swaminathan, Balaji Sangeetha
Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai 600077, India.
Department of Orthopaedics, Government Medical College, Omandurar Government Estate, Chennai 600002, India.
World J Methodol. 2025 Mar 20;15(1):94833. doi: 10.5662/wjm.v15.i1.94833.
This article explores the ethical considerations surrounding the reporting of off-label and experimental treatments in medical case reports, with a focus on fields such as oncology, psychiatry, and pediatrics. It emphasizes the balance between innovation and evidence-based medicine, highlighting the critical role of case reports in disseminating clinical experiences and advancing medical knowledge. The discussion delves into the ethical framework guiding case reporting, including principles of patient autonomy, informed consent, non-maleficence, beneficence, justice, and transparency. Challenges such as negative outcome reporting, commercial interests, and the balance between innovation and caution are examined. Recommendations for ethical vigilance, the development of comprehensive guidelines, and the role of regulatory bodies are proposed to ensure patient safety and uphold scientific integrity. The article concludes by underscoring the importance of a collaborative effort among clinicians, researchers, ethicists, and regulatory bodies to foster the responsible advancement of medical science while adhering to the highest ethical standards.
本文探讨了医学病例报告中关于非标签治疗和实验性治疗报告的伦理考量，重点关注肿瘤学、精神病学和儿科学等领域。它强调了创新与循证医学之间的平衡，突出了病例报告在传播临床经验和推进医学知识方面的关键作用。讨论深入探讨了指导病例报告的伦理框架，包括患者自主、知情同意、不伤害、有益、公正和透明等原则。还审视了诸如负面结果报告、商业利益以及创新与谨慎之间的平衡等挑战。提出了关于伦理警觉、制定综合指南以及监管机构作用的建议，以确保患者安全并维护科学诚信。文章最后强调了临床医生、研究人员、伦理学家和监管机构之间合作努力的重要性，即在坚持最高伦理标准的同时促进医学科学的负责任发展。
