Circumcision and HIV prevention research: an ethical analysis

A large randomised controlled trial in 3274 men between the ages of 18 and 24 years showed that circumcision resulted in a significant 60% reduction in HIV infection. If these results were to be confirmed by two continuing (unpublished) trials there would be grounds to advocate circumcision as a public health intervention in high prevalence areas. Several ethical issues arose in relation to this trial such as the decision not to disclose participants HIV status to them during the trial the decision to pay participants and early termination at the request of the trials monitoring board. We address the ethical implications for future HIV prevention research both for biological interventions such as vaccine and microbicide trials and for behavioural interventions such as counselling. First is there an ethical obligation to provide all male participants in future trials of HIV vaccines and other preventive methods with circumcision (as well as counselling and access to condoms)? Second should future prevention trials select or stratify participants by circumcision status? Third should the design of such trials be altered in light of the established effectiveness of circumcision--eg by requiring circumcision for the control groups? (excerpt)