Trials not reviewed by UNAIDS

The article by Ronald Bayer on placebo-controlled clinical trials for HIV is a thoughtful and well-crafted analysis of the ethical issues prompted by those trials. However, the article contains an error that should be corrected. Bayer writes that the placebo-controlled studies of HIV transmission “have been examined by local review committees and an ethics committee ofUNAIDS.”

In fact, the UNAIDS-sponsored trials were initiated by the earlier Global Programme on AIDS of WHO, before UNAIDS was established. UNAIDS does have an Ethical Review Committee (ERC), which I chair. The ERC prospectively reviews all protocols sponsored by UNAIDS. The committee did not examine the protocols of the UNAIDS-sponsored perinatal transmission studies, either before the trials were launched or after they were already in progress. At one of its meetings, after the controversy had erupted, the ERC did devote a brief session to discussion of the ethical concerns of those trials. There was no attempt to reach a consensus, and no clear consensus emerged.