But some of the measures introduced to try to offer such protectionsuch as
arguing that participants should have access to the same standards of care made
available in developed countriesare impractical and can undermine potential
research opportunities, it says. The conclusions follow a discussion paper
issued by the council in 2002 and a subsequent meeting in Cape Town, South
Africa, in February 2004, attended by 58 participants from 28 countries,
including India, China, Kenya, and Botswana.
The discussion paper published by the council looks at the current laws
governing research in developing countries, including the 1964 Declaration of
Helsinki, which has since been amended five times by the World Medical
Association and clarified by the Council for International Organizations of
Medical Sciences. Research in developing countries is crucial, the paper says,
for improving health care. But researchers in these countries often cannot
conduct their own research, making partnership with more developed countries
essential. The existing guidelines, meant to clarify that relationship, are
"markedly inconsistent," says Professor Peter Smith of the department
of infectious and tropical diseases at the London School of Hygiene and Tropical
Medicine, who is a member of the reports steering group. "In addition,
faithful adherence to some of the provisions within the guidelines is often
unachievable," he said. "The possibility that researchers may forgo
conducting valuable research in developing countries because sponsors in
developed countries . . . may judge it incompatible with specific provisions of
guidance continues to be a cause for concern," says the Nuffield
councils report. Many researchers were unsure whether the Helsinki
declaration was intended as completely binding or whether it was more of a
"gold standard" that they should merely aim for. And even though the
idea that everyone should give consent to being involved in research, the
practicalities of this were sometimes very difficult in some settings in
developing countries.
In one trial of a malaria treatment, for example, in Malawi, artesunate
suppositories were offered as an immediate initial treatment for children
suspected of having malaria. The intention was, eventually, to use them before
the child was transported to a larger hospital where diagnosis of malaria could
be confirmed. However, they had to be trialled in a hospital setting, and the
children were often already semiconscious by the time researchers saw them. The
researchers found it unrealistic to convey the detailed consent
informationwhich covered two pages of text and involved translation problems
for words like "randomization" and "drug
absorption"particularly when the mother was worried about her ill child.
There has also been considerable debate about whether trial participants
should receive the best standard of care available worldwide or the best
available in their country. Similarly, if a treatment is already available in
the developed world, but not in the country where the trial is taking place,
debate continues about whether that treatment should be offered to participants,
or just a placebo. The paper suggests that situations may exist where use of a
placebo is acceptablefor example, when the existing treatments (such as for
river blindness, for which a new drug was tested in the mid-1980s) were known to
have potentially harmful side effects.
Another controversial area, says the report, is whether a drug company should
continue to provide treatments once the trial ends. In Brazil, for example, the
government insisted that drug companies had to provide a product for HIV/AIDS
treatment if the drug proved effective in the trial. Initially this jeopardised
the research, because the companies were reluctant to agree to this, but they
eventually complied and the trial went ahead. One company provided two years
supply of enfuvirtide (T20) free after the trial ended.
Related links: www.nuffieldbioethics.org
(Source: BMJ, March 19, 2005)
Printer-friendly version