Navigating the ethical terrain: Off-label and experimental treatments in medical case reports.

Madhan Jeyaraman, Naveen Jeyaraman, Swaminathan Ramasubramanian, Sangeetha Balaji
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Abstract

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.

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