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More Information on Ethics and Clinical Trials

Ethics Require the Inclusion of Condoms and Counseling in Anti-HIV Microbicide Trials

This letter, by Health Research Group Deputy Director Peter Lurie, M.D., MPH and Director Sidney Wolfe, M.D., appeared in the American Journal of Public Health, July 2000.

Potts is correct that in anti-HIV microbicide trials, "the number of volunteers [in the trial] who are going to be infected will be the same" whether or not condoms and counseling are provided.[1] But, more importantly, the number of people who are not infected would be considerably higher if condoms and counseling were provided, because those interventions would prevent some infections.

Potts worries that more subjects would be needed for a study with condoms and counseling than for a study without these interventions. This can be addressed, however, by more actively recruiting participants and by using group sequential designs. Would Potts agree to a trial that was suboptimal scientifically in order to speed it up? If not, why is he willing to countenance studies that are suboptimal ethically for the same reason?

As a substitute for intratrial condoms and counseling, Potts suggests, the microbicide could be guaranteed to the community after it is proved effective. This raises several concerns. First, why are interventions and microbicides mutually exclusive? Researchers should ensure both intratrial interventions and posttrial availability of effective microbicides. Second, the physician-researcher's primary responsibility is to the study participants. According to the Declaration of Helsinki, "[c]oncern for the interests of the subject must always prevail over the interests of science and society."[2] The ethical requirement for beneficence is not some charitable obligation that researchers themselves can decide how (and with whom) to satisfy; it is an obligation toward the study participants.

Third, Potts' "solution" assumes that the microbicide will prove effective, a rather theoretical claim given that a decade of anti-HIV microbicide research, including 2 large clinical trials, has not yielded an eddective product. This assumption puts the theoretical saving of lives in the future over the certain saving of trial participants' lives in the present. What will Potts say to the participants in an unsuccessful microbicide trial, conducted without condoms or counseling, who become HIV-positive?

Fortunately, Potts' proposal is unlikely to hold sway. Although we find the UNAIDS vaccine trial ethics guidance document to be deeply flawed (see our critique at it does make clear that "[a]ppropriate risk-reduction counseling and access to prevention methods should be provided to all vaccine trial participants, with new methods being added as they are discovered and validated."[3]

Peter Lurie, M.D., M.P.H.

Sidney M. Wolfe, M.D.



[1] Potts M. Thinking about vaginal microbicide testing. Am J Pub Health. 2000;90: 188-90.

[2] World Medical Association. World Medical Association Declaration of Helsinki: recommendations guiding physicians in biomedical research involving human subjects. Available at: Accessed May 4. 2000.

[3] Joint United Nations Programme on HIV/AIDS. G/1idance Document on Ethical Considerations in HIV Preventive Vaccine Research. Available at: Accessed May 4. 2000.

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