E-drug:American research without a requirement for American
IRB review (cont)
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Dear colleagues,
I have been involved in ethical reviews of clinical researches involving
human subjects in my previous institution in Indonesia.
There are occasions where clinical trial protocols are not cleared by the
home institutions in a developed country, but these protocols are submitted
to be undertaken in our institution. There are a lot of pressures to the
committee to clear such protocols, even if the committee think that the
protocol may not meet the ethical (often scientific as well) principles.
Such pressure derives from various factors, desires for having prestige by
undertaking clinical research with foreign support, expectation of obtaining
financial benefits in the era of self financing mechanisms in many medical
institutions, etc.
Even we have noticed earlier a big community trials involving pregnant
women, where the protocols were actually not approved by the ethics
committee. Such situation can not be improved alone from the developing
countries perspective. Collaborative efforts involving international donors,
companies, and medical institutions from developed countries and developing
countries are needed, to promote good and ethical clinical trials in
developing countries.
Budiono Santoso
WHO
Manila
SANTOSOB@wpro.who.int
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