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World J Methodol. Dec 20, 2025; 15(4): 107699
Published online Dec 20, 2025. doi: 10.5662/wjm.v15.i4.107699
Evolving ethos of medical research: A retrospective analysis of the declaration of Helsinki (1964-2024)
Jovan Yi Jun Liau, Vishal G Shelat
Jovan Yi Jun Liau, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore 308232, Singapore
Vishal G Shelat, Department of General Surgery, Tan Tock Seng Hospital, Singapore 308433, Singapore
Author contributions: Shelat VG contributed to conceptualization; Shelat VG and Liau JYJ contributed to writing; Shelat VG contributed to supervision.
Conflict-of-interest statement: All authors declare that there is no conflict of interest.
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: Vishal G Shelat, Adjunct Associate Professor, FRCS, Department of General Surgery, Tan Tock Seng Hospital, 11 Jalan Tan Tock Seng, Singapore 308433, Singapore. vgshelat@gmail.com
Received: March 28, 2025
Revised: April 20, 2025
Accepted: June 7, 2025
Published online: December 20, 2025
Processing time: 129 Days and 22.9 Hours
Abstract

The World Medical Association’s Declaration of Helsinki (DoH) serves as a key document of ethical guidance advocating principles of medical research involving human participants. Since its inception in 1964, the DoH has undergone several revisions, reflecting a dynamic evolution in our understanding of research ethics, spurred by gaps identified within the document, harms discovered, challenges identified during ongoing research activities, scientific advancements and societal shifts in values. The DoH addresses a challenge and a conflict that may arise between two key aspects of medical research: On one hand, the fundamental obligation of physicians to do no harm, and on the other, the essential need to ensure the efficacy and safety of medical interventions by testing them on human research participants or healthy volunteers. With each revision, increasing emphasis is given to distributive justice and beneficence and not only to patient autonomy. Despite being a comprehensive and concise document, occasional criticism is reported, such as with regards to the impracticability of obtaining informed consent amongst other challenges. This essay will examine the key changes across the DoH's iterations, highlighting the progressive strengthening of participant protection and the evolving relationship between research, societal benefit, and individual rights.

Keywords: Ethics; Declaration of Helsinki; World medical association; Medical research; Informed consent

Core Tip: The current 2024 revision of the Declaration of Helsinki (DoH) marks the 11th version of the DoH since its inception in 1964. Throughout the past 60 years, many notable controversies in medical ethics have arisen, such as the Tuskegee syphilis study and the harvesting of the HeLa cell line. Following these incidents, iterations of the DoH have increasingly emphasized distributive justice and beneficence, rather than focusing solely on patient autonomy. This essay will examine the key changes across the DoH's iterations, highlighting the progressive strengthening of participant protection and the evolving relationship between research, societal benefit, and individual rights.