II. A Brief History of Research Ethics Violations and Regulation

As Lurie and Wolfe pointed out in the New England Journal of Medicine

"Some officials and researchers have defended the use of placebo-controlled studies in developing countries by arguing that the subjects are treated at least according to the standard of care in these countries, which consists of unproven regimens or no treatment at all. This assertion reveals a fundamental misunderstanding of the concept of the standard of care. In developing countries, the standard of care (in this case, not providing zidovudine to HIV-positive pregnant women) is not based on a consideration of alternative treatments or previous clinical data, but is instead an economically determined policy of governments that cannot afford the prices set by drug companies...

Acceptance of a standard of care that does not conform to the standard in the sponsoring country results in a double standard in research. Such a double standard, which permits research designs that are unacceptable in the sponsoring country, creates an incentive to use as research subjects those with the least access to health care." [1]

[1] Peter Lurie and Sidney M. Wolfe, 1997. "Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries." The New England Journal of Medicine 337(12):853-856.

P14Zidovudine, one of the antiretroviral therapy drugs used to treat mother-to-child transmission of HIV, but which was not provided to ART trial participants in Africa. Photo by Mike Blyth. Copyright Creative Commons, some rights reserved.