학술논문
Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries
Document Type
Academic Journal
Author
Source
JAMA, The Journal of the American Medical Association. Jan 26, 1994, Vol. v271 Issue n4, p295, 7 p.
Subject
Language
ISSN
0098-7484
Abstract
Planners of HIV vaccine trials in developing countries should consider the ethical and social issues of the host country and the behavioral practices of its population. Host countries should be selected in consultation with country scientists and government officials. Subject selection should adequately represent the proportion of women and local minorities in the population. Public education and behavior modification counseling should be conducted even if it may alter the effectiveness of the vaccine. Informed consent must be obtained from all subjects and compensation must not be excessive so that people are coerced into participating in the trial. All materials, measurements and interventions must be sensitive to local and cultural customs. Confidentiality must be maintained to avoid discrimination against volunteers because of their participation. Effective vaccines should be made available free of charge or at reduced prices to the host country.
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 social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future acquired immunodeficiency syndrome (AIDS) research in the host nation. Description of the Project.--Twelve investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues. Conclusions.--Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial include the following: (1) researching vaccines active against developing world HIV isolates; (2) establishing and maintaining an adequate technological infrastructure; (3) assessing the feasibility of recruitment in countries where the existence of HIV may be denied; (4) designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or community elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and treatment groups; (7) making available laboratory methods to distinguish between natural HIV infection and vaccine-induced seropositivity; and (8) guaranteeing that an effective vaccine is available free of charge to the placebo group and at affordable prices to other host country residents.
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 social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future acquired immunodeficiency syndrome (AIDS) research in the host nation. Description of the Project.--Twelve investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues. Conclusions.--Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial include the following: (1) researching vaccines active against developing world HIV isolates; (2) establishing and maintaining an adequate technological infrastructure; (3) assessing the feasibility of recruitment in countries where the existence of HIV may be denied; (4) designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or community elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and treatment groups; (7) making available laboratory methods to distinguish between natural HIV infection and vaccine-induced seropositivity; and (8) guaranteeing that an effective vaccine is available free of charge to the placebo group and at affordable prices to other host country residents.