Clinical trials in "developing" countries: is there a special "Third World" ethic?
Rothman, D.J.
Zeitschrift für Arztliche Fortbildung und Qualitatssicherung 97(10): 695-702
2003
ISSN/ISBN: 1431-7621 PMID: 14997587 Document Number: 554452
With increasing frequency, clinical trials are carried through in countries of the "third world". In particular, recent studies aimed at establishing the efficacy of new AIDS therapies, or AIDS vaccines, applied lower ethical standards than those formulated by the Declaration of Helsinki of the World Medical Association, and accepted in the US and internationally,--although American researchers and institutions were involved in these studies. The paper reconstructs the controversies following the publication of these studies, and analyses the conditions for the existence of such double standards of research ethics. Particular attention is given to the concept of informed consent and the difficulties to put it into practice in different cultural contexts.