Jeyaraman M, Jeyaraman N, Ramasubramanian S, Balaji S. Navigating the ethical terrain: Off-label and experimental treatments in medical case reports. World J Methodol 2025; 15(1): 94833 [DOI: 10.5662/wjm.v15.i1.94833]
Corresponding Author of This Article
Madhan Jeyaraman, MS, PhD, Assistant Professor, Research Associate, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Velappanchavadi, Chennai 600077, India. madhanjeyaraman@gmail.com
Research Domain of This Article
Medical Ethics
Article-Type of This Article
Editorial
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Madhan Jeyaraman, Naveen Jeyaraman, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Chennai 600077, India
Swaminathan Ramasubramanian, Sangeetha Balaji, Department of Orthopaedics, Government Medical College, Omandurar Government Estate, Chennai 600002, India
Author contributions: All authors contributed important intellectual content to the manuscript, reading and approving the final manuscript.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Madhan Jeyaraman, MS, PhD, Assistant Professor, Research Associate, Department of Orthopaedics, ACS Medical College and Hospital, Dr MGR Educational and Research Institute, Velappanchavadi, Chennai 600077, India. madhanjeyaraman@gmail.com
Received: March 26, 2024 Revised: July 15, 2024 Accepted: July 18, 2024 Published online: March 20, 2025 Processing time: 186 Days and 22.8 Hours
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.
Core Tip: This article underscores the imperative of ethical integrity in reporting off-label and experimental treatments within medical case reports, advocating for a balanced fusion of innovation and evidence-based medicine. It calls for collective action in developing comprehensive ethical guidelines and enhancing regulatory oversight to prioritize patient safety and uphold scientific rigor.
