KEY TAKEAWAYS
- In late 2024, the Declaration of Helsinki underwent its most radical update in 60 years, including a revision to protect healthy volunteers.
- However, critics suggest there is still a way to go and that other aspects of research ethics need to be incorporated, such as how to ensure the benefits of clinical research are felt by trial participants and their communities.
The World Medical Association (WMA) recently updated a key ethical framework, the Declaration of Helsinki, at a scale not seen since the Declaration’s inception in 1964. As reported by Cathleen O’Grady in Science, the WMA hope that the changes will help to drive new standards in research equity.
“Humans”, not “subjects”, and the importance of healthy volunteers
As outlined by O’Grady, the 2024 revisions, which mark the tenth time the document has been updated, struck a new tone, with the Declaration’s title now referring to “human participants” rather than “human subjects”. The revisions, published in JAMA with accompanying editorial, also include the first ever mention of healthy volunteers, rather than considering only patient participants in research.
The 2024 revisions, which mark the tenth time the document has been updated, struck a new tone, with the Declaration’s title now referring to “human participants” rather than “human subjects”.
Expanded scope
These important steps forward are not the only signs of the Declaration’s expanded scope and ambition. Other changes include:
- a direction that all those involved in medical research should adopt the Declaration’s principles, not just doctors.
- a focus on ensuring vulnerable groups are included in medical research. Previous guidance aimed at protecting groups such as pregnant people inadvertently led to their exclusion from clinical trials. The revised Declaration notes that this can exacerbate disparities and that the harms of exclusion and inclusion should both be considered.
Radical, but complete?
The WMA General Assembly unanimously supported the 2024 update, which Dr Ashok Philip, President of the WMA, described as a “landmark revision”. However, as reported by O’Grady, some feel the revisions should have gone even further and that there are still key omissions, namely:
- Benefits for participants and the wider community: the update does not look at ways to ensure that trial participants and their communities benefit from research.
- Other types of research: the Declaration’s focus remains medical research, with epidemiological and behavioural studies not yet covered.
- Data protection: the use of data from insurance or pharmaceutical company databases in research, and related issues of informed consent, are not discussed.
Nevertheless, the Declaration of Helsinki remains a cornerstone of ethical conduct in medical research, and the latest revisions provide an important focus on the dignity of research participants. Chair of the revision workgroup, Dr Jack Resneck Jr, calls on all involved in medical research to uphold these renewed principles.
————————————————–
