Nuffield council calls for ethical framework for developing world rese
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《英国医生杂志》
A sound ethical framework for research in developing countries is crucial for ensuring that participants are safe from exploitation, says a report from the Nuffield Council on Bioethics.
But some of the measures introduced to try to offer such protection—such as arguing that participants should have access to the same standards of care made available in developed countries—are 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 report抯 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 council抯 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 information—which covered two pages of text and involved translation problems for words like "randomisation" 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 acceptable—for 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.(Lynn Eaton)
But some of the measures introduced to try to offer such protection—such as arguing that participants should have access to the same standards of care made available in developed countries—are 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 report抯 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 council抯 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 information—which covered two pages of text and involved translation problems for words like "randomisation" 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 acceptable—for 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.(Lynn Eaton)