The World Medical Association (WMA) has updated its cornerstone ethical principles for medical research to modernize protections and reinforce respect for the rights and interests of human participants, while including new language on global justice, public health, vulnerability and consent for personal data collection and reuse.
For 60 years, these principles—dubbed the Declaration of Helsinki for the city in Finland where WMA members assembled to formally adopt them—have guided ethical conduct for medical research involving human participants on a global scale.
The WMA General Assembly, whose constituent members represent more than 10 million physicians, recently met to adopt additional revisions crafted by an AMA-led work group from 19 countries. Through eight regional and topical meetings on many continents and two global public-comment periods, the work group gathered feedback from other experts and stakeholders including researchers, patients, bioethicists, regulators, medical leaders and others.
The AMA delegation to the World Medical Association plays a major role in proposing and authoring global policy issues including medical ethics, access to high-quality medical care, the physician workforce, public health, medical education, and advocacy for physicians’ and patients’ rights. As the predominant U.S. medical association, the AMA is the only national medical association eligible for membership in the World Medical Association, which was founded in 1947 in the wake involvement by physicians in medical atrocities during World War II.
The landmark amendments to the Declaration of Helsinki highlight the commitment “to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies,” said WMA President Ashok Philip, MD, in a statement.
Jack Resneck Jr., MD, chair of the WMA Declaration of Helsinki revision work group and a former AMA president, expounded on these latest changes in a JAMA® Viewpoint article and in a podcast interview with JAMA Editor-in-Chief Kirsten Bibbins-Domingo, PhD, MD, MAS.
Last revised more than a decade ago, the Declaration of Helsinki “takes on complex ethical issues with inherent conflicts, strives for brevity while some thirst for specificity, exists in global political environments, and seeks to address a rapidly innovating research ecosystem,” wrote Dr. Resneck, who chairs the dermatology department at the University of California, San Francisco.
The 2024 revision “represents a meaningful renewal of this seminal ethical document that demands respect for and protection of all medical research participants,” added Dr. Resneck.
Research participants—not “subjects”
Several key revisions augment respect for individuals participating in medical research as partners and co-creators in the advancement of science and knowledge. In one key change, WMA replaced the term “subjects” with “participants” throughout the document. New language further calls for “meaningful engagement with potential and enrolled participants and their communities … before, during and following medical research.”
Another change sought to broaden the Declaration of Helsinki’s focus beyond physicians.
New language states that “principles should be upheld by all individuals, teams and organizations involved in medical research, as [they] are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.”
While some have questioned the WMA’s authority to address nonphysicians, the Declaration of Helsinki is not just about physician self-regulation, Dr. Resneck wrote in his JAMA essay.
“The medical profession’s morals and broader ethics include a duty to ensure respect for the health, dignity, integrity, autonomy, and privacy of research participants,” he wrote, no matter who is conducting that research.
The WMA also amended parts of the document addressing “physicians and other researchers” to recognize the large, physician-led, interdisciplinary teams that often conduct medical research.
“This acknowledges that many of the outlined responsibilities (and rights of participants) apply regardless of the training and profession of the researcher or research team member,” Dr. Resneck wrote.
Subscribe to free AMA email newsletters
Get the latest news from the AMA on the topics that matter to you—delivered to your inbox.
Look at who benefits, who’s burdened
The medical research enterprise cannot be solely responsible for resolving inequities, noted Dr. Resneck. However, “passionate testimony during regional meetings described ongoing failures of some researchers and sponsors to ethically address this challenge,” he added.
For this reason, new language calls on researchers to “carefully consider how the benefits, risks and burdens of research are distributed” to address inequities and global justice.
Updates broaden the purposes of medical research to include advancing public health. However, in light of Nazi war crimes and other historical medical abuses that led to the Declaration of Helsinki, the workgroup retained existing language which states that while individual research participants do choose to subject themselves to risk for the good others after free and informed consent, those broader public health purposes “can never take precedence over the rights and interests of individual research participants.”
Don’t exclude “vulnerable” by default
A Declaration of Helsinki provision outlining protections for vulnerable individuals and groups generated substantial discussion during regional and topical meetings.
“Impassioned and consistent feedback contended that starting with a default of exclusion for all those in positions of vulnerability had resulted in enormous gaps in medical knowledge about certain populations,” exacerbating inequities, wrote Dr. Resneck. This was especially true for women, children, and people from historically marginalized racial and ethnic groups.
New language “recognizes that vulnerability may be contextual and dynamic and experienced at varying levels,” he explained. The work group also retained language that protects particularly vulnerable individuals, including those who are incapable of giving free and informed consent,
Obtain consent for personal data use
One of the more substantial rewrites involved the section previously focused on informed consent for biobanking. Prior language failed to adequately address the growing risks and need for consent and privacy protections related to the increased use of stored personal data after trials. Augmented intelligence (AI), machine learning, genetic data collection, capacity to reidentify deidentified data, and commercial and political data misuse all contribute to these concerns, wrote Dr. Resneck.
“New language calls for free and informed consent for the collection, processing, storage and foreseeable secondary use of biological material and data and for ethics committee approval and monitoring of such databases and biobanks,” he wrote.
This updated section also cross-references the WMA Declaration of Taipei, “which includes more detailed guidelines on rights of individuals and principles of governance for health databases and biobanks broadly,” he added.
Other revisions acknowledge the impact of the global COVID-19 pandemic. One provision states that the Declaration of Helsinki’s principles should be upheld during public health emergencies, even if such circumstances call for urgent interventions.
Three JAMA editors—Dr. Bibbins-Domingo, Deputy Editor Linda Brubaker, MD, MS, and Executive Editor Greg Curfman, MD—also have weighed in with an editor’s note, “The 2024 Revision to the Declaration of Helsinki: Modern Ethics for Medical Research.” It is part of a special package in the journal that includes the full text of the 2024 declaration. The other published JAMA Viewpoint articles are:
- “Revisions to the Declaration of Helsinki on Its 60th Anniversary.”
- “Declaration of Helsinki—Revisions for the 21st Century.”
- “The Revision of the Declaration of Helsinki Viewed From the Americas.”
- “Future-Proofing Research Ethics—Key Revisions of the Declaration of Helsinki 2024.”
- “Revisiting the Declaration of Helsinki—A Patient-Centered Perspective.”
- “The Revised Declaration of Helsinki—Considerations for the Future of Artificial Intelligence in Health and Medical Research.”
Learn more about AMA leadership and policy development through the World Medical Association.
