When the Baragwanath Perinatal HIV Research Unit submitted its list of items that needed to be financed as part of the forthcoming HIV vaccine trials, it made for interesting reading: included on the list is R600 for a sacrificial goat.

The Baragwanath Hospital unit, one of the two clinical sites chosen for the vaccine trials, is taking scientific research into a new realm by including the community in all stages of its project.  

Before the research process has even begun, the community advisory board, which includes youth and church groups, nurses and traditional healers, is already up and running. It will be educating the community about the vaccine, advising the scientists on how to work with the community, and helping to recruit and select volunteers to participate in the vaccine trials. It has already produced a comic book on the vaccine.

But if the project is to be a success, a goat must first be sacrificed to appease the spirits of the ancestors, say the traditional healers, and a ceremony is being arranged.

“This is our contribution to science,” said Eftyhia Vardas, who heads the Baragwanath HIV vaccine unit.  

This contribution of involving the community in making decisions is not only about checking that the research is carried out ethically, but also about ensuring that once the vaccine becomes available, it is understood and accepted by people, she said. One only needs to look at the part the public has played in fighting for access to Nevirapine, to realise how important it is to have the community on board should any constraints to post-trial access to the Aids vaccine be encountered.

Ever since HIV vaccine trials began in Africa in 1997, the scientific community has been thrown into tumult as its traditional western codes of conducting ethical research are no longer showing the way in guiding science and in protecting research participants. Researchers in developed countries are having to ask themselves whether it is ethical to conduct research in developing countries that they would not do back home.

The response so far has been simply to overlay the ethical guidelines drawn up by the Western world on all countries of the globe, but they are not always relevant to different cultural contexts which means that in the end they have limited impact in guiding research and in ensuring that participants are not exploited or harmed.  

The vaccine trials lead to an explosion of questions about whether their ethical guidelines were working and whether developing countries have the capacity in terms of personnel and review boards   to ensure that the guidelines are followed.

The answer has been to create a forum for discussing ethics which has researchers from developing countries at its centre. This Global Forum for Bioethics in Research, which met recently in Cape Town, agreed that there are often gaps between ethical guidelines and actual research.

The concept of community involvement was at the centre of discussions at the forum and with informed consent being the cornerstone of ethics, an example from South Africa is showing the way.

The University of Natal Psychology Department is investigating ways of ensuring that rural women, in particular, are not exploited in the trials which are due to begin in Durban – the second designated clinical site.

Doug Wassenaar, a psychologist at the University, said that in the build-up to HIV vaccine trials, there was a real concern emerging about whether women would have enough information about the process and enough autonomy to be able to give informed and voluntary consent.

“We have overwhelming information that for many women in sub-Saharan Africa, voluntariness and the experience of consent are either absent or compromised, particularly for those women most likely to be candidates for HIV vaccine trials,” he said.

Informed consent was a cornerstone of ethical research, he said, but   in practice it was often more concerned with legal indemnity than with a process supporting informed voluntary decision making.  

The nature of vaccine trials and the many risks involved meant it was important that genuine consent be sought, yet western notions and guidance on informed consent failed to engage with the experience of vulnerable research participants, especially rural women.

There was a need to bridge these two worlds, and the bridge had to be built on more than articles of faith and aspirational ethical codes and guidelines. It required intensive research into the social dynamics of the trial site research, which was informed by the experiences of women, to link science and bioethics.