Acquired Immune Deficiency Syndrome (“AIDS”) has emerged as a health issue of global significance, and clinical research on Human Immunodeficiency Virus (“HIV”) and AIDS has become increasingly international in scope. A clinical trial of a vaccine designed to prevent the spread of the HIV raises important legal and ethical questions because injection drug users who were believed to be unsuitable subjects for study in the United States were singled out for research in Thailand. The protections for human subjects must not be compromised when U.S. pharmaceutical companies conduct research abroad, particularly where clinical trials are conducted in vulnerable populations. U.S. regulations, as well as international declarations and guidelines, require two primary protections for research subjects: individual voluntary informed consent, and prior review of proposed research by an independent ethical review committee. Ethical review committees should gauge the adequacy of informed consent by the substance of the information communicated between researcher and participant, and should not be satisfied with a mere signature on a consent form. The recent clinical trial of HIV vaccines in the United States and Thailand highlights the gaps and weaknesses in the current system of protections for human subjects. Members of the committees that reviewed the protocols for the AIDSVAX vaccine failed to properly consider the vulnerability of the subject population and the implications for informed consent. Countries that host research sponsors, as well as countries that host research volunteers, must share the responsibility of protecting human subjects. To strengthen the protections for human subjects, Thailand should enact comprehensive national legislation, and existing legislative protections in the United States should be expanded to reflect the increasingly international scope of biomedical research. As a case study, the AIDSVAX clinical trials can provide useful information for planning more equitable HIV vaccine trials in the future.
Joan M. Doherty,
Form over Substance: The Inadequacy of Informed Consent and Ethical Review for Thai Injection Drug Users Enrolled in HIV Vaccine Trials,
15 Pac. Rim L & Pol'y J.
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