Intended for healthcare professionals

Rapid response to:


Revising the Declaration of Helsinki

BMJ 2013; 346 doi: (Published 08 May 2013) Cite this as: BMJ 2013;346:f2837

Rapid Response:

Re: Revising the Declaration of Helsinki

As this editorial has aptly summarised, "research on vulnerable people should be carried out only if the same answers cannot be obtained another way".

Indeed, vulnerable populations need protection from harm and exploitation and at first sight, this new requirement might sound like a good idea. For instance, who would want to argue that a refugee in a war-torn country or a terminally ill infant should be enrolled in a clinical trial that can be undertaken on non-vulnerable participants?

One would assume that a ban on such research would provide added protection to the already disadvantaged. However, such a ban would also create new injustices at least for those vulnerable populations that are able to consent as the following two examples show.

The case of direct health benefits
Poor, pregnant women with HIV in Africa are probably one of the best examples of a vulnerable population in need of protection. Yet, in the complex ethical debates about the HIV transmission prevention studies, nobody demanded that these women should be stopped from taking part in the studies because they had not yet been conducted on a non-vulnerable population. However, this is what the draft revision of the Declaration of Helsinki would require.

Even research with a very high likelihood of immediate direct health benefit could not be conducted on a vulnerable population unless it had already been carried out on a non-vulnerable population. This would disadvantage vulnerable populations twice. First they are disadvantaged already due to the source of their vulnerability, and second they would now be blocked from accessing a research study with immediate health benefits. This would be unjust for those vulnerable populations who are able to consent as the women in the HIV transmission prevention studies.

The case of minimal risk and minimal burden research
Some types of research carry minimal risk and minimal burden, for instance, genetic studies with reliable procedures for data protection. Another example of a highly vulnerable population would be sex workers working in a slum with no access to health care. What would happen, if the new draft of the Declaration of Helsinki were accepted with regard to minimal risk and minimal burden research on vulnerable populations?

In collaboration between the University of Nairobi and the University of Manitoba, a clinic in the Majengo slums of Nairobi has been conducting genetic and epidemiological studies on sexually transmitted diseases for several decades. Access to the clinic is restricted to sex workers who – in return for sample donation – receive comprehensive and long-term health care, including anti-retrovirals [1, 2]. Women interviewed at the clinic all expressed their appreciation for the clinic, the services and the personnel. ("Whatever kind of sickness I get, I am treated. So this clinic has a lot of benefits") [2].

Research on sexually transmitted diseases does not have to be undertaken in the slums of Nairobi, it could be undertaken on non-vulnerable populations. And it would have to be if the latest draft revision of the Declaration of Helsinki were implemented. Yet, it would be highly patronizing to tell the clinic's research participants that their individual informed consent will now be overruled - for their own protection - by a ban on the kind of studies they are enrolled in. The research is minimally burdensome and minimally risky, yet carries considerable indirect health benefits for the participants.

Looking at these two examples, one has to conclude that the new requirement added to the Declaration of Helsinki could be unfair in the case of research with direct health benefits and patronizing in the case of research, which carries minimal risk and minimal burden. In both cases, those participants who are able to give informed consent should continue to be given the opportunity to decide for themselves.

(1) Lavery JV, Bandewar SVS, Kimani J, Upshur REG, Plummer FA, Singer PA. Relief of oppression: An organizing principle for researchers’ obligations to participants in observational studies in the developing world. BMC Public Health, 2010, 10(384).

(2) Schroeder D, Gefenas E, Chennells R, Fournier V, Feinholz D, Sirugo G. Realizing Benefit Sharing: Is there a Role forEthics Review? In: Schroeder D, Lucas CJ (eds) Benefit Sharing – From Biodiversity to Human Genetics, 179-201, 2013; Springer, Dordrecht.

Competing interests: No competing interests

08 May 2013
Doris Schroeder
Professor and Director of Centre for Professional Ethics
Eugenijus Gefenas (Vilnius University)
University of Central Lancashire UK and Charles Sturt University, Canberra
Brook 317, Preston PR1 2HE