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[e-drug] Ethics of clinical trials in developing countries (3)

E-DRUG: Ethics of clinical trials in developing countries (3)

dear E-druggers,

It seems to me that there may be a chicken and egg problem here - I would
argue that it would be very desirable for there to be "local ethics
committee" approval for wherever the study is conducted.  In the USA this is
required so that both my institution's ethics committee and the ethics
committees at all of the performance sites must approve the protocol.  It is
common for local committees to add additional stipulations.  If the research
is supported by the NIH it is mandatory that there be local approval even if
the performance site is outside of the USA.

In developing countries how prevalent are ethics committees?  What if the
study is not being conducted at a major medical institution - are there
applicable committees?  In the USA there are commercial ethics committees
which will review protocols for private practitioners who may not be under
the jurisdiction of any institutional ethics committee.  Are there similar
resources available in developing countries?


J. Philip Miller, Professor of Biostatistics
Washington University School of Medicine
Director of Biostatistics Core, Siteman Cancer Center
Mail: Campus Box 8067, 660 S. Euclid Ave
St. Louis, MO 63110
Physical Address: 3349 Barnard
Phone: 314-362-3617, 314-362-3728 (fax)
email: jphilipmiller@wustl.edu 
web: http://www.biostat.wustl.edu/~phil

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