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Third Forum - Meeting Report                              Page 1, 2
21 - 23 February 2002
CAPE TOWN, SOUTH AFRICA

     
 

Page 1, 2

Meeting Report
The ethics of conducting clinical research in developing countries have lately aroused heated debate, largely among those in the developed world. It is hardly surprising that passions are running high when the ethical principles guiding clinical trials have been predominantly created in developed countries. But where are the voices of the developing countries themselves in all this? What are their views on the best ways to protect research participants?

The Global Forum on Bioethics in Research - an informal partnership of several organizations with a shared interest in this area - enables developing-country perspectives to take centre stage. At its annual gatherings, developed and developing country participants come together for frank and wide-ranging discussions centered on practical issues. At the recent Forum in Cape Town, which was organised by the UK Medical Research Council, the problems of pursuing ethical purism were readily apparent. Or as one participant put it: "We can’t simply give principles as if shining light down from above; we have to start from the practical and then move to the principle".

The Forum drew the participants - 120 individuals from some 40 nations including 20 African countries - into a process of thinking about very complex ethical issues. This helped them discover where their own values lay and how these values could translate into a new approach for handling ethical challenges. In conducting research, the questions on the science alone are difficult, and when the layer of ethics is added to that, it is often very difficult for the researcher to know which is the best way to proceed.

 

 

 

 

12 - 14 FEBRUARY 2004
CAPE TOWN, SOUTH AFRICA

A follow-up Workshop will be held in February 2004 to explore developments in this area since the publication of the Report.  The Workshop, co-hosted by the South African MRC and the Nuffield Council on Bioethics

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Sometimes, when faced with difficult choices, those concerned may decide that the most ethical route would be not to proceed with the study at all. But if the outcome of the study would , for example, be a vaccine which would save the lives of a great number of children, then the decision has to be carefully balanced. Is it ethical to block research that would assist many just because it does not meet the ‘gold standard’ of ethics?

"You get stuck sometimes and you need to find a balance. In the end you have to see where to compromise," was the view of one delegate from a developing country.

The Global Forum, unlike other bioethics gatherings, did not begin at the point of lofty philosophical principles but rather with the practical everyday problems that scientists faced, and from this starting block it beat a path through to an ethical principle. Along the way, there were many twists and turns with groups considering the case studies sometimes coming up with completely divergent views on what would be the ethical route to take at each juncture of complicated cases - for example, what would happen to people who had been harmed through participating in a drugs trial? How would researchers arrive at a decision that one group of children would not be vaccinated for the purposes of their study?

A recurring theme was the gap that exists between ethical guidelines and actual health research practice. In clinical trials, for example, the risks and possible benefits, both during and after the trial, are not always disclosed.

There are a myriad of guidelines, but many participants were concerned that they are all set within a framework of predominantly Western thinking, which means that their potential to guide research in developing countries is limited. The question was raised as to why having a few developing country representatives on the committees which have traditionally prepared the guidelines was not enough. The answer that came from developing country participants was that it was difficult to influence the thinking of such committees in a fundamental way and there was a need for engagement of developed and developing country representatives on equal terms. Only an entirely new approach could move the process from the centre, but that depended on shaping national guidance frameworks in developing countries.

Another question asked throughout the forum was do existing guidelines work and do countries have the capacity to follow them?

HBE

John E. Fogarty International Center

Medical Research Council

NIH

NICHD

National Eye Institute


OPAS Brazil

National Institute on Drugs Abuse


Center for Disease Control and Prevention

Wellcome Trust

 National Institute of Dental and Craniofacial Research
 


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