Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans

The World Medical Association (WMA) has announced the adoption the 2024 Revision of the Declaration of Helsinki (DoH), the global reference for medical research involving human participants, at its General Assembly in Helsinki, Finland.

Newly inaugurated President of the WMA, Dr Ashok Philip said, “This landmark revision of the Declaration of Helsinki highlights the World Medical Association’s 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.

“This was a mammoth revision process spanning 30 months, and the World Medical Association extends its heartfelt thanks to everyone who participated,” continued Dr Ashok Philip, President of the World Medical Association.

Under the leadership of Dr. Jack Resneck Jr., Chair of the WMA Declaration of Helsinki revision workgroup, the revision team concluded that some areas of the document had to be updated to ensure the Declaration’s continued relevance. The 2024 revision of the Declaration of Helsinki provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research.

“Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says that as physicians, it’s part of our moral obligation to ensure that our patients and the participants in research are respected and treated with dignity,” said Dr Jack Resneck Jr.

“The revised Declaration of Helsinki calls on everybody involved in the research enterprise now to uphold those principles, whether they are individuals or teams or organizations across the medical research activity,” he continued.

Dr Resneck Jr. highlighted some new language in the sixth paragraph of the Declaration as important, saying, “To really address the theme of distributive and global justice, this change means that the Declaration of Helsinki calls on researchers to carefully consider how the benefits, the risks, the burdens of research are distributed.”

The substantive changes to the Declaration of Helsinki can be categorised in two areas:

• Participant-centered inclusion, respect and protection, including recognition of participant vulnerability, calls for community engagement, pursuit of global justice, obtaining informed consent, and use of participant-centered language.
• Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens.

More information

• See the Declaration of Helsinki 2024 full text here.
• See JAMA Viewpoint Revisions to the Declaration of Helsinki on Its 60th Anniversary A Modernized Set of Ethical Principles to Promote and Ensure Respect for Participants in a Rapidly Innovating Medical Research Ecosystem, by Dr Jack Resneck Jr.
• Listen to JAMA Author Interview with Dr Jack Resneck Jr. Declaration of Helsinki Addresses New Ethical Challenges
• See WMA Declaration of Helsinki 2024 interview with Dr Jack Resneck Jr
• Read Background information on the Declaration of Helsinki here