HIV vaccine trials present special ethical concerns. First, HIV vaccine trials must go forward with less preclinical evidence of efficacy than other interventions. This is because a good animal model does not exist, HIV is highly variable and undergoes rapid mutation, and there is little information about how to build protection against HIV. Nevertheless, because of the enormous suffering caused by HIV, such trials are ethically appropriate if there are credible scientific reasons to believe the candidate vaccine may be effective.

Second, vaccine trial participants may mistakenly believe that they will receive protection from the vaccine and, therefore, may increase risky behaviors. This issue is a particular concern because, unlike most vaccines, HIV vaccines are unlikely to confer full immunity. While researchers need outcomes (i.e., seroconversions--positive HIV tests in persons who previously tested negative for HIV) to evaluate the efficacy of the vaccine candidate, they also have an obligation to protect research participants. Accordingly, researchers must provide high-quality riskreduction counseling and emphasize the uncertainty about the effectiveness of the candidate vaccine to all participants, even though, if such counseling were totally effective, the clinical trial would be undermined. To avoid this potential conflict, it may be necessary to have separate staff for the counseling and research aspects of the trial.

Finally, HIV vaccine trials pose unique risks to participants. Participants may be prevented from participating in future vaccine trials, and subsequently developed vaccines may be less effective for them. In addition, because participants may react positively to certain HIV antibody tests, they may be excluded from certain professions and activities, even if their seroconversion does not represent a true infection. Subjects may also face stigmatization from family or friends to whom they disclose information. Mere participation in some trials may identify the subject as someone at high risk of contracting HIV. Because of the high stakes if confidentiality is breached, researchers should take extra steps to protect the confidentiality of the information they collect in HIV vaccine trials.

In summary, the HIV epidemic has raised new ethical and policy dilemmas and has forced reconsideration of established guidelines and policies that apply to a much broader range of issues. In the future, controversies will likely continue to focus on addressing the global impact of HIV/ AIDS and what justice requires in healthcare access and research.

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