2013 was an auspicious year for medical research. A new vaccine for malaria was developed, there was a revolution in DNA analysis, and there was a major advance in human cloning when stem cells were produced from cloned human embryos.
But ethicists interested in medical research also had much to feast on in 2013 because the Declaration of Helsinki - one of the most important statements ever published about the ethics of using human participants in research - was updated at the end of the year.
The declaration celebrates its 50th anniversary in 2014 and it has been revamped to provide more guidance to physicians as they traverse the moral maze of 21st-century medical research. But not everyone is celebrating. Many physicians and ethicists have already criticised the new declaration, as they have previous incarnations.
No one seriously doubts the need for ethical oversight of medical research involving people. A quick glance at the more infamous research trials conducted by Nazi doctors and other physicians in the 20th century quickly puts paid to any such suggestion. But the Declaration of Helsinki, following in the footsteps of the Nuremberg Code, lays down some specific rules – as well as some general principles – which all physicians involved in medical research must abide by. Once broad principles are fleshed out, furore invariably follows.
Protecting vulnerable groups
However the declaration is a hugely important document. And there are some valuable new additions. In particular, there is a new focus on protecting “vulnerable groups”. Vulnerable research participants come in all shapes and sizes, but it is poor people living in developing countries who will benefit most from this new focus. This is because a growing number of universities and pharmaceutical companies based in the developed world now conduct research in developing countries. This is not necessarily problematic, but there is an increased risk of exploitation.
The declaration also now makes clear that medical research involving vulnerable groups should only take place if the research is responsive to the health needs of the group and if the research cannot be carried out on non-vulnerable groups.
It also specifically states that if a medical intervention is identified as beneficial in a trial, then the people who participated in it should be able to access it after the trial has finished. There has been much controversy of late about the need for post-trial access to successful interventions because it seems unethical to test something in a particular group then fail to provide ongoing access once it has been shown to be effective.
Previous versions of the declaration allowed the use of placebos in certain situations and the new version seems to open up the possibility of using them more frequently. Placebos can be great way to find out whether a new drug actually works. But using them to test a new intervention can be ethically problematic if another intervention, which has already been shown to work, could be used instead. However, researchers haven’t been given the green light – much to the annoyance of some – and “extreme care must be taken to avoid abuse of this option”.
A greater focus on the protection of the vulnerable might also help researchers avoid the problems that recently arose in two large cervical cancer screening studies in India that were investigated when concerns were raised about the large number of participants in the control groups who died from cervical cancer.
We can’t all agree
All of this will no doubt invite more criticism from some – it is a further narrowing of principles after all. But the drafters of the declaration have done the right thing in producing a document that is more focused. They should also be thanked for producing a document which conforms more closely with other research ethics guidelines and reduces the possibility that researchers will end up having to choose between seemingly contradictory ethical requirements.
What is needed now is to give the declaration more bite. Israel has incorporated the declaration into national law and many other countries have created legislation which makes direct reference to the document. Others should follow suit.
In the middle of the last century the Doctors’ Trial exposed the brutality of the medical research that was conducted by Nazi physicians in concentration camps across Europe. The World Medical Association responded by publishing a document that outlined the rules that should govern research involving human beings. As it celebrates its half-centenary the Declaration of Helsinki ought to be commended for its achievements and lauded for its attempt to protect research participants from the worst excesses of medical science.