The Declaration of Helsinki focuses on research ethics and, like me, is 60 years old. It was first adopted by the World Medical Association (WMA) in June 1964 at their meeting in Helsinki, hence the name. The WMA describe the Declaration as ‘the global reference for medical research involving human participants’. As medical research ethics developments are often influential for other disciplines and sectors, even though medical research ethics do not always translate smoothly to social research contexts, the Declaration is also a key reference for social research in general.

The Declaration has been revised a number of times, most recently in October 2024. The latest revisions are the culmination of an extensive global consultation process over 30 months involving physicians, patients, members of research ethics committees, and others. From my perspective, some of the revisions seem like the WMA are playing catch-up, e.g. it is only in this latest iteration that they have stopped talking about ‘human subjects’ and started talking about ‘participants’. (Regular readers may remember that I have ranted about this before.) But other revisions seem rather more forward-looking.

For a start, the 2024 revisions use the phrase ‘physicians and other researchers’, when previous iterations seemed to regard physicians as the only people who would be doing medical research. This is definite progress as of course it is not only physicians who are able to conduct medical research.

The Declaration’s position on harm to the environment has been strengthened from ‘minimise possible harm’ to recommend avoiding or minimising harm to the environment and striving for environmental sustainability. That is quite a big move, and an important one in the current global context.

The latest iteration specifies that ‘medical research takes place in the context of various structural inequities’ which was not previously mentioned. Also, the previous version specified that medical research ‘must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research’, but mostly focused on risks. The latest version uses ‘risks and burdens’ throughout, and widens ‘individuals and groups’ to ‘individuals, groups, and communities’.

A more radical statement is: ‘When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.’ This is laudable but may be difficult to implement as some countries still have little or no research ethics governance. Even so, I think it’s a worthwhile aim, and may even help to speed up the process of devising good quality research ethics governance systems for places where they do not yet exist.

The revised Declaration says quite a bit about research ethics committees (RECs) and their remit. The previous version from 2013 said that RECs must have the right to monitor ongoing studies (which just goes to show that the implementation of the Declaration has its limits, as many RECs still do not do this). The latest version says that RECs ‘must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research.’ That is quite a big shift. It suggests that the work of RECs may need to become more relational and dialogical, rather than being primarily compliance-based, which I think would be a good thing. However, it also has implications for the staffing and resourcing of RECs, as well as for the ethical work of researchers, because more monitoring etc means more time which means more money. I wonder where the WMA think that could come from.

Some of the revisions are specifically about medical procedures such as clinical trials, which are as important as any other revisions from the WMA’s perspective but are not as relevant to non-medical research. However, the revisions highlighted in this post, and no doubt others too, will reverberate through research ethics work around the world for years to come.