On 19 October 2024, the new version of the Declaration of Helsinki was released.

In June 2024, the PREPARED project submitted written comments, which have been taken on board by the World Medical Association (WMA) Working Group who developed and revised the Declaration.

The Declaration was first issued in 1964 and is now one of the most influential ethics guidelines world-wide. It emphasizes the importance of conducting research safely and ethically, minimising risks, and ensuring the well-being of research participants.The WMA Working Group have made great efforts to consult all relevant stakeholders. Consultations were undertaken in workshops, for instance at meetings in Johannesburg, at the Vatican, Washington and Munich, and written consultations were open to all at several stages.

In June 2024, the PREPARED team submitted written comments. 

The PREPARED team commented on Articles 19 and 20 (the articles focused on vulnerable groups and individuals), and three changes were made following our recommendations:

• Article 19 focuses on the risks that those in situations of vulnerability can incur when they are involved in research. The drafters focused on potential harm, whilst we suggested that ‘being wronged’ should be retained from an older version. For instance, research that uses deceit can wrong research participants, even if it does not harm them. 
• To avoid the unnecessary exclusion of people in situations of vulnerability from research, the new Declaration allows their responsible inclusion. We requested the phrasing to be changed to “fairly and responsibly included in research”. This will ensure that people in situations of vulnerability will not be blocked from research unnecessarily, but it will also ensure that they are not over-researched; research participants in difficult situations should not have to endure fleeting visits by a procession of researchers who all want to extract information. 
• Article 20 expanded on protections for “some” individuals, groups, and communities that experience more vulnerability than others. We noted that the focus on “some” can be misleading as all those in situations of vulnerability should benefit from the protections. 

text text

PREPARED partners followed the work of the WMA Working Group.

In May 2024, our PREPARED colleagues from Shanghai and Bonn attended the Munich consultation for the Declaration of Helsinki. The discussions in Munich emphasised the need to promote inclusion in research while still ensuring protections for vulnerable populations. One conversation looked at the layered and complex nature of vulnerability, highlighting how it affects individuals in different ways. Another focused on how to improve engagement with diverse groups in research.

In May 2024, we also launched ‘Vulnerability Revisited’ at the PREPARED Conference in Amsterdam, a book which focuses on redefining the concept of “vulnerability” in research ethics so that no-one is left behind in research. 

In June 2024, when the final phase of the consultations on the Declaration opened, the team submitted a response on the two vulnerability articles, as noted above. In October 2024, our colleague from Seoul, Prof. Ock-Joo Kim, was present when the revised declaration was approved by the World Medical Association. She said: “It was very exciting to be present at the formal ceremony with delegates from national medical associations from around the world. We all wanted to get it right, because the Declaration will be used globally to maintain high ethical standards.”

We congratulate the Working Group on the 2024 revision of the Declaration of Helsinki and welcome the new version. 

Written by: Prof. Doris Schroeder, UCLan Cyprus and Corinna Pannofino, Trilateral Research.