topic, the National Bioethics Advisory Commission recommended that independent bodies in both the United States and the host country ensure that studies are consistent with ethical requirements in both countries. Where necessary, the commission recommended, resources should be given to the host country to perform this review. The Department of Health and Human Services (DHHS) is now soliciting comments on ways to improve international research by better identifying equivalent principles and practices for protecting human subjects in research conducted abroad (DHHS, 2005).

Before HIVNET 012 began, two IRBs provided oversight of the study’s design and protocol. The U.S.-based IRB, at Johns Hopkins University, was the Joint Committee on Clinical Investigation (JCCI). The Ugandan-based IRB, of the Uganda National Council for Science and Technology, was the AIDS Research Committee (ARC). Both IRBs approved the protocols and consent forms for the study, and continued their oversight during its implementation.

The decision to participate in research must be voluntary as well as informed. Even when risks are reasonable and investigators obtain informed consent, soliciting certain people as participants may nonetheless be unacceptable. Studies should not enroll people who are not fully capable of resisting the request to become participants—such as prisoners and other institutionalized or otherwise vulnerable persons—merely because they are accessible.

The historical emphasis on protecting people from exploitation, however, has failed to anticipate a time when, at least for some areas of medical research, people would demand the right to join certain studies because they might provide access to an innovative therapy, or provide the only chance for medical care for life-threatening diseases. In international research, some commentators have suggested that the general absence of adequate health care in resource-limited-settings can make the offer of enrollment in a research trial nearly impossible to resist. Studies in resource-limited countries, therefore, demand a high level of justification. Studies that exploit a population’s vulnerability—such as those that recruit people in poorer countries solely to benefit people in wealthier countries—should not be done. If, on the other hand, studies in resource-limited countries are designed to address important health problems in those same countries and could not be performed elsewhere, then the research is justified, and the consent process is used to help ensure that subjects are genuinely informed before volunteering (National Bioethics Advisory Commission, 2001a,b).

This chapter focuses on four ethical issues related to HIVNET 012: