The Declaration of Helsinki: A Pillar of Medical Ethics Under Revision
Research has always been a cornerstone of scientific progress. This is equally true for medicine, where human subjects are involved. However, the absence of regulation in the past allowed for abusive practices, particularly targeting disadvantaged groups in contexts of war and oppression. In response to these concerns, numerous initiatives were undertaken to regulate medical research. This led to the adoption of the Declaration of Helsinki in 1964, which has evolved over the decades to address contemporary challenges. But did you know that the Declaration is currently undergoing revision?
Yes, consultations have taken place, and the revised version will be presented during the World Medical Assembly in October 2024.
In August 2024, a regional consultation took place with North America, hosted by the American Medical Association. During this consultation, a session “Maximizing impact: Communications, advocacy and implementation” was organized by the World Medical Association. WMA was represented by its President, Dr Lujain Alqodmani, and its Secretary General, Dr Otmar Kloiber. Other organizations involved included the Council for International Organizations of Medical Sciences (CIOMS), represented by Prof. Dr. Hans Van Delden; the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP), represented by Professor Cheiko Kurihara; and Professor Lara Bloom from the International Alliance of Patient Organizations (IAPO)
Introduced by Dr Alqodmani, the session particularly focused on the importance of community engagement, the need to protect the legitimacy of the Declaration of Helsinki, and the call for greater inclusivity.
Dr Alqodmani emphasized the importance of co-creation and partnerships in the development of the Declaration of Helsinki. She stressed the need to move beyond the traditional doctor-patient relationship to include broader interactions with society. Expressing her satisfaction with the inclusion of community engagement in the latest revisions, Dr Alqodmani sees this as a significant step toward establishing frameworks that support both post-trial access and the creation of social value.
Dr Kloiber provided an historical overview of policy revision procedures within the WMA. He recalled that revisions were traditionally conducted in a closed manner. This non-inclusive approach led to heated controversies, particularly during the 1996 revision when a rushed amendment regarding the use of placebos was made without adequate consultation. This prompted the WMA to adopt a more open revision process. However, while the WMA has become more inclusive over the years, it remains crucial for the World Medical Association to preserve ownership of the Declaration of Helsinki to safeguard its integrity and authority.
Although the Declaration of Helsinki is an essential resource in its field, it is not the only document addressing research ethics. For example, the CIOMS International Ethical Guidelines for Health-Related Research Involving Humans and the WMA Declaration of Taipei also address ethical issues.
CIOMS was established by UNESCO and WHO in the aftermath of World War II, specializes in bioethics and pharmacovigilance. While the CIOMS guidelines are more detailed and useful for research ethics committees, they remain aligned with the Declaration of Helsinki, reducing potential conflicts, as highlighted by the CIOMS representative, Hans van Delden, full professor of medical ethics, University Medical Center, Utrecht University, the Netherlands,
A central question raised by Chieko Kurihara, BA, Ethics Working Group of the International Federation of Pharmaceutical Physicians and Pharmaceutical Medicines Development (IFAPP) concerned the status of the Declaration of Helsinki. “Should it be considered the highest ethical principle or merely a minimum requirement?” Ms Kurihara also stressed the need to link the Declaration of Helsinki with other ethical guidelines, such as the Taipei Declaration, to support data-driven research
Patient representatives were also consulted in this inclusive revision process. Lara Bloom, board member, International Alliance of Patient Organizations, expressed her enthusiasm for recent language changes in the revision of the Declaration of Helsinki, which better respect the rights and autonomy of individuals. She welcomed the shift from the term “subjects” to “participants” and the removal of gendered language. However, she hopes that future revisions will adopt more inclusive language, such as using “people with lived experiences” instead of “patients” in research contexts, to acknowledge the full humanity of those involved.
Dr Jack Resneck Jr., Chair, Declaration of Helsinki Revision Workgroup, thanked all the speakers for their inputs and the variety of perspectives brought to the meeting. He stated that many speakers have managed to simultaneously acknowledge the privilege it is to be in positions to contribute to the revision of the Declaration of Helsinki, to think about this document that has so much influence, and at the same time, they have managed to call out where they think we can do better, which is important.
The Declaration of Helsinki remains a crucial document in research ethics. Although there are other ethical texts, it continues to be the reference for high-level principles that all medical researchers must follow. As society, technology, and contexts evolve, the Declaration requires periodic revisions to stay relevant and reflect contemporary ethical standards. Like the current one, future revisions must be inclusive, allowing diverse stakeholder participation.
However, as emphasized by the speakers, it is essential that the Declaration retains its authority and legitimacy, with structured revisions only when necessary. Once revised, the work does not stop there. Public awareness of the importance of the Declaration of Helsinki and its impact on their lives must be raised. It must also be continuously adapted to new realities through a collective effort involving the entire medical community.
