What are some of the potential ethical problems with this study?

Investigators sponsored by the NIH and private foundation are conducting an HIV vaccine trial in a sub-Saharan African nation. In the trial, HIVnegative adolescents will be randomized to receive either an experimental vaccine or a placebo. They will be instructed on ways to prevent HIV infection and provided with condoms. They will be followed for fi ve years to see if either group has a higher HIV infection rate. They will be tested for HIV on a regular basis and interviewed concerning their sexual activities and other risky behaviors. If they develop HIV, they will be treated according to the standard of care in the sub-Saharan nation, which includes access to only some of the HIV medications available in the developing world. Subjects who develop HIV will receive free medication for a maximum of one year. There are no plans to compensate subjects for research-related injuries. Interviews with some of the subjects participating in the trial revealed a profound lack of understanding of the purpose of the study and its procedures. Many participants thought they were receiving treatment for HIV rather than an HIV vaccine. A data monitoring committee found that people who received the vaccine had an increased risk for arthritis and diabetes.

• What are some of the potential ethical problems with this study?

• Should an HIV vaccine be tested on adolescents?

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