Sixty years of ethical evolution: The 2024 revision of the Declaration of Helsinki (DoH)

On October 19, 2024, the 75th General Assembly of the World Medical Association (WMA) in Finland adopted the latest version of the Declaration of Helsinki (DoH)—Ethical Principles for Medical Research Involving Human Participants [1] (hereafter referred to as “the Declaration”). This revision process took 30 months, with the working group comprising representatives from medical associations in 19 countries and regions. From April 2022 to September 2024, the working group held eight regional expert meetings and two times global consultations, gathering suggestions from both experts and the general public [2]. Besides, the working group developed regular online meeting working mechanisms.

Basically, the general ethical principles for respecting and protecting human participants are stable over time, while more tailored interpretations and justifications should be adapted in a timely manner. The revision focused on alignment with wide-accepted ethical guidelines at the international level, emphasizing coherence with other related documents within, and beyond the WMA. The Declaration emphasises the overarching principles and does not delve into many specifics; however, its core principles remain universally applicable.

While these revisions represent significant progress, some also reflect substantial compromises. Notably, to strengthen the protection of research participants’ rights and well-being, the Declaration reaffirms that “These purposes can never take precedence over the rights and interests of individual research participants” and requires all stakeholders, including individuals, teams, and organizations involved in medical research to adhere to ethical principles that respect for and protect of research participants [7]. Given the WMA's mandate as a global organization of physicians, the term “medical research” was retained rather than adopting broader terminology such as “health-related research.” However, the document refers to “physicians,” or “physicians and other researchers” in constituent paragraphs, acknowledging both the critical role of physicians in medical practices and the specialized division of roles in research involving human participants. Compared to the 2013 version, the new Declaration strengthens researchers' responsibilities and protections for research participants (e.g., Articles 9, 10, 12, 17, 21, 23, 32, and 34), increasing the instances of the word “must” from 46 to 58 and clarifying the distinction between “should” and “must.”

Renaming “subjects” as “participants” not only mandates respect for participants' rights and agency but also calls for a partnership between researchers and participants. Developing such partnership requires that physicians/researchers strictly fulfill their duties, with the best interests of patients, including those participating in research, as the priority, promoting and protecting their health, well-being, and rights, and safeguarding participants' life, health, dignity, integrity, autonomy, privacy and confidentiality. Furthermore, researchers must consider fair equitable distribution of risks, benefits, and burdens, and more actively to enable engagement from various stakeholders—especially participants and their communities—who can express and share their priorities and values. The term “enable,” chosen after extensive discussions, implies that researchers should actively engage and interact meaningfully with participants and their communities. In this regard, participants can even initiate research by interacting meaningfully with researchers, voicing health needs, and inspiring research questions and directions. Researchers' proactive engagement not only entails formulating relevant scientific questions but also creating and providing opportunities for potential participants to engage in research.

With this partnership in mind, special attention has been given to particularly vulnerable individuals, groups and communities. The Declaration defines vulnerability as potentially arising from “factors that may be fixed or contextual and dynamic,” emphasizing that such populations should not be arbitrarily excluded. Instead, if such individuals are to be included, researchers must uphold a fair and responsible approach, ensuring compliance with three specific protective measures. This approach shifts from traditional exclusion for protection to inclusion for protection, respecting these populations' unique health needs and priorities as a key aspect of respect for marginalized groups.

Regarding the ethical guidelines for the use of data or biological material in medical research, the revisions only reflect a minimum consensus, leaving quite a lot room for improvement. The ethical issues surrounding the use of data or biological material in medical research settings, especially concerning data governance and dynamic informed consent, were key points of focus. The final revision aligns with the WMA's Declaration of Taipei by emphasizing the risk of re-identifying previously deidentified data [8]. It assigns Research Ethics Committees the responsibility to carefully oversee informed consent processes, especially when existing data and specimens are reused in medical research, as well as in particular situations when obtaining informed consent is impossible or impractical. However, the revisions do not fully address the urgent need for solutions in data governance and dynamic information in the emerging context of big data and AI in healthcare [9].

Although the Declaration has yet to establish specific ethical guidelines for cutting-edge fields like medical AI, it provides general principles and a foundation for further development [10]. The Declaration itself undergoes regular revisions, and over the next decade, as ethical governance in related fields continues to improve, it is likely that a more refined and unified global ethical consensus will emerge. Achieving this, however, will require active engagement and thorough collaboration among all stakeholders.

Haihong Zhang: Conceptualization (equal); writing—original draft (lead); writing—review and editing (equal). You Wu: Writing—original draft (lead). Haibo Wang: Conceptualization (equal); resources (lead); supervision (lead); writing—review and editing (equal). Weili Zhao: Writing—review and editing (equal). Yali Cong: Conceptualization (lead); supervision (lead); writing—review and editing (equal).

Professor Haibo Wang is a member of the Health Care Science Editorial Board. To minimize bias, he was excluded from all editorial decision-making related to the acceptance of this article for publication. The remaining authors declare no conflicts of interest.

Tsinghua University Start-up Fund, Grant/Award Number: 53335000124.

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