ETHICAL, BEHAVIORAL, AND SOCIAL ASPECTS OF HIV VACCINE TRIALS IN DEVELOPING-COUNTRIES

Issue.-Several investigators are preparing to conduct efficacy trials of human immunodeficiency virus (HIV) vaccines in the developing world . Failure to adequately address the unique ethical, behavioral, and so cial issues that surround vaccine testing in that setting will jeopard ize the success of these trials and future acquired immunodeficiency s yndrome (AIDS) research in the host nation. Description of the Project .-Twelve investigators from Africa, Asia, North America, and South Ame rica reviewed previous experience with HIV trials in developing countr ies and explored potential solutions to these issues. Conclusions.-Hos t country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for cond ucting the trial include the following: (1) researching vaccines activ e against developing world HIV isolates; (2) establishing and maintain ing an adequate technological infrastructure; (3) assessing the feasib ility of recruitment in countries where the existence of HIV may be de nied; (4) designing methods to obtain informed consent from each indiv idual subject, rather than exclusively from family members or communit y elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and t reatment groups; (7) making available laboratory methods to distinguis h between natural HIV infection and vaccine-induced seropositivity; an d (8) guaranteeing that an effective vaccine is available free of char ge to the placebo group and at affordable prices to other host country residents.