Moral Standards for Research in Developing Countries: From "Reasonable Availability" to "Fair Benefits"‪.‬

Over the last decade, clinical research conducted by sponsors and researchers from developed countries in developing countries has grown very controversial. (1) The perinatal HIV transmission studies that were sponsored by the National Institutes of Health and the Centers for Disease Control and conducted in Southeast Asia and Africa inflamed this controversy and focused it on the standard of care--that is, on whether treatments tested in developing countries should be compared to the treatments provided locally or to the best interventions available anywhere. (2) Since then, this debate has expanded to include concerns about informed consent. A subject that has received less discussion but is potentially even more important is the requirement that any drugs proven effective in the trial be made available to the host population after the trial. (3) There seems to be general agreement that "reasonable availability" is necessary in order to ensure that the subject population is not exploitated.