The declaration of Helsinki recently turned 60, but don’t feel bad if you missed the celebrations. It probably passed unnoticed by most people not working in the medical field – and possibly even a good few in the field.
If you’re not familiar with the declaration – adopted by the World Medical Association on October 19 1964 – here is an explainer on this highly influential document: how it emerged, how it evolved and where it may be heading.
What is the declaration of Helsinki?
The World Medical Association was set up in the late 1940s in response to atrocities committed in the name of medical research during the second world war. It was focused on promoting and safeguarding medical ethics and human rights.
Agreed at a meeting in Finland in 1964, the first version of the declaration included principles that have become the cornerstone of global research ethics. These include the importance of carefully assessing the risks and benefits of research projects, and seeking informed consent from those taking part in research.
The declaration has been hugely influential and has been incorporated into national guidelines relating to medical research around the world. (For example, in the UK it is cited in legislation and policy relating to research.)
However, it is not legally binding. It has also, at times, been the focus of controversy. For example, following an intense debate in the early 2000s – about the use of placebos in drug trials and the ethics of conducting research in low-income countries – the US Food and Drug Administration removed reference to the declaration in its own guidance.
The declaration updated
It has been revised several times (the new version is the eighth edition), reflecting an evolving understanding of medical ethics, contemporary debates about when research would be ethical, as well changes in the nature and landscape of research.
Some of these reflect important shifts in values and language. In 1964, the declaration stated that clinical research “should be conducted … under the supervision of a qualified medical man” – sexist language that has long since gone by the wayside.
The 2024 version refers to “research participants” rather than “research subjects” - in response to a wider shift to greater inclusion of patients and research volunteers as partners in research. There are also new references to concern for the environment and sustainability, as well as attention to issues relating to stored data and biomaterial, such as tissue samples.
Continuing uncertainty
Some questions remain. One change in the recent document emphasises the importance of including participants from different backgrounds in research, including those who are potentially “vulnerable” in one or more ways.
Older versions of the declaration emphasised avoiding research wherever possible involving children, older patients, pregnant women, those with mental illness and prisoners. This came from a need to learn from past scandals and avoid exploiting vulnerable groups.
However, more recently, it has been recognised that excluding these groups can cause even greater harm, since it leads to a lack of evidence on how best to treat some patients. This then leads to disparities in health. For example, a large proportion of medicines commonly used for children lack high-quality evidence to support them.
The 2024 declaration tries to balance the priority to include vulnerable groups in research with the need to protect and avoid research that could be feasibly performed in other groups.
However, this highlights a deeper problem. Ethical problems arise when research is inhibited or discouraged.
Regulation of research (as encouraged by the declaration) is hugely important, but it can also make it extremely difficult, time consuming and resource intensive to perform. Doctors may change practice based on experience, intuition or inspiration. If they do so outside of a trial, they are not required to seek the approval of any review body.
As noted by a British paediatrician Richard Smithells in the 1970s: “I need permission to give a drug to half of my patients [to find out whether it does more good than harm], but not [if I want] to give it to them all.”
One particular form of research that can be important to drive improvements in care are so-called comparative effectiveness trials. Within many areas of medicine, there are variations in practice, where some professionals will take one approach, while others will take another.
Depending on which doctor you happen to see, (perhaps which clinic you attend, or which day of the week you become unwell), you might receive one treatment or the other.
Since variations like this affect many patients, it would be important to determine which is the better option, potentially involving a randomised controlled trial, where one group of patients is randomly selected to receive the treatment and another group (the control group), a placebo. These trials take years to conduct and are very expensive to run.
However, the declaration seems to encourage a one-size-fits-all approach and potentially implies that such trials should go through a formal and lengthy research ethics approval process, with participants providing explicit informed consent. However, many ethicists and researchers have argued in favour of a more slimmed-down regulatory approach focusing on what matters: do trials meaningfully add risk or burden to those that patients would have encountered outside the trial. And would taking part in research restrict patients’ ability to make meaningful decisions, and to make choices that would ordinarily have been offered?
For example, imagine a trial of two different antiseptics that are commonly used for surgery. Being involved in the trial wouldn’t impose additional risk (since patients ordinarily receive those antiseptics), and it wouldn’t remove an ordinary choice, since it would be rare for medical professionals to ask patients which antiseptic they would like.
The Declaration of Helsinki may be 60 years old, but it continues to both stimulate debate and inspire ethical practice in medical research. It has been newly revised but it is likely that innovations in research, such as the growing use of AI in medicine, will require further changes in the years ahead. It isn’t time to retire it yet.
Dominic Wilkinson receives funding from The Wellcome Trust. He is a member of the British Medical Association Medical Ethics Committee (the views in this article are his own).
This article was originally published on The Conversation. Read the original article.
