E-drug: American research without a requirement for American IRB review (cont)
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Copy of letter sent to NBAC
Dear sir/madam,
I am appalled that an amendment to the draft code of international
ethics tabled at the meeting of 22nd November omits the requirement
"AS WELL AS BY A U.S. IRB" in a draft proposal that now reads
"Clinical trials conducted in developing countries and subject to
U.S. research regulations must, as a minimum, be given prior approval
by an
independent ethics review committee in the country where the research
will take place."
This is a move that is either cynical or inept and 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.
For your body to endorse this proposal would suggest that it is morally
bereft and would rightly invite international opprobrium.
Yours faithfully
Neil Hunt
Neil Hunt, Lecturer in Addictive Behaviours; Director of Research, KCA
Kent Institute of Medicine and Health Sciences
Research and Development Centre
University of Kent at Canterbury
Canterbury
Kent CT2 7PD
Email: N.Hunt@ukc.ac.uk
Tel/voicemail: +44 (0) 1227 824090
Fax: +44 (0) 1277 824054
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