E-drug: American research without a requirement for American IRB review (cont)
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Hello: You make an excellent point of raising concern over the
possibility of IRB's from developing countries "will enable
contentious, risky or just plain poor research to be undertaken on
populations who lack the proper protections that are rightly expected
in the US and other developed countries."
However, I wonder what the basis is for such claim[s]?" The IRB
requirements in the U.S. are rarely more than window dressing for the
clinical research product approval process these days [my personal
opinion, without offering substantiated evidence at this point]. I
might also add, that maybe, just maybe, IRB's in developing countries
are quite capable of "protecting" their fellow countrymen. And,
hopefully, these IRB's from developing countries will insist that
clinical research on their populations include the requirement that
any clinical research data be collected in strict accordance with GMP
standards [something that the developing countries avoid like the
Plague!]. Reliable, accurate data. Now, wouldn't that be nice for a
change. Just my two cents worth.
Tom
Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2044 Plumas Street Reno, NV 89509-3708
Phone: 775-829-1799
admin@worldccr.org http://worldccr.org
[Perhaps a parallel scenario is one found in Australia where
Aboriginal communities require people wishing to be involved in
research with Aborigines to satisfy the requirements of their own
Aboriginal ethics committees, rather than hospital or university
ethics committees. BS]
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