E-DRUG: Clinical trials and ethics (7)
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Dear friends,
Clinical research programs that address the health problems of vulnerable
populations are absolutely needed, so I agree that, rather than limiting the number of settings where clinical trials may be conducted, we should take strict precautions to avoid abuses (e.g., vulnerable populations may be "used" to conduct researches at lower costs, in treatment-naïve populations and in a non-strictly regulated environments).
Independent ethical review should prevent unethical practices, in particular by enforcing the principle that "medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research" (art.17 of the Declaration of Helsinki, as updated at the 59th WMA General Assembly in Seoul, October 2008).
With regards to ethical review, I would like to support the point of view of those who recommend that clinical trials funded or sponsored by Northern
organizations in developing countries, should be subject to ethical review
both in the country/ies where the research takes place and in the country of the Sponsor: the complementarities of the points of view could ensure a
better protection of the subjects and populations, help to avoid
double-standard practices and prevent exploitative studies to be carried out by Northern Sponsors in the South.
I also would like to ask the opinion of those interested in clinical
research, about the recent decision of the US FDA to end the need to comply
with the Declaration of Helsinki for clinical trials conducted outside the US (a decision that seems to depart from the principle of avoiding double
ethical standards):
Regards,
Raffaella
Raffaella Ravinetto
Institute of Tropical Medicine Prince Leopold
Antwerpen, Belgium
rravinetto@itg.be