Education And Debate

An ethical dilemma: availability of antiretroviral therapy after clinical trials with hiv infected patients are ended

BMJ 1997; 314 doi: https://doi.org/10.1136/bmj.314.7084.887 (Published 22 March 1997) Cite this as: BMJ 1997;314:887
  1. Peter E Cleaton-Jonesb
  1. a Committee for Research on Human Subjects (Medical) University of the Witwatersrand Johannesburg South Africa
  2. b Committee for Research on Human Subjects (Medical), University of the Witwatersrand, Johannesburg, South Africa

    Article

    Guidelines on good clinical practice for drug trials clearly state that ethics committees must ensure that the safety, integrity, and human rights of the subjects participating in a particular trial are protected.1 Fundamental concepts are informed consent and risk or benefit to participants in a trial. For many clinical trials, ethical clearance is straightforward but those involving people infected with HIV generally are not.

    Here, we are dealing with a condition that is presently incurable with variable progression, drug treatment is expensive, and emotions run high. These matters are common to all countries, but those of us living in Africa have an added burden–Third World conditions and an estimated 13 million people infected with HIV, usually from heterosexual sex.2 In South Africa the most recent published results for the fifth unlinked anonymous national HIV survey show that HIV infection in women attending antenatal clinics has risen from a national average of 1.35% in 1991 to 7.57% in 1994.3 In some parts of the country the rate is as high as 14.35% and is increasing.3 Because of a shortage of resources, antiretroviral drugs for treating HIV are not provided by South African public …

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