Academic journal article Washington International Law Journal

Form over Substance: The Inadequacy of Informed Consent and Ethical Review for Thai Injection Drug Users Enrolled in HIV Vaccine Trials

Academic journal article Washington International Law Journal

Form over Substance: The Inadequacy of Informed Consent and Ethical Review for Thai Injection Drug Users Enrolled in HIV Vaccine Trials

Article excerpt


Acquired Immune Deficiency Syndrome ("AIDS") has become a health epidemic that no community, nation, or continent can ignore. AIDS is the "first modern infectious disease to strike the developed and developing world simultaneously and to give both a large stake in finding a cure."1 As biomedical research becomes increasingly international in scope, clinical trials often involve several nations that are socially, politically, and economically distinct.2 When clinical research is conducted in both developed and developing nations, a system of protections is necessary to ensure that the treatment of human subjects does not vary with the location of the research.

Federal regulations in the United States and most international guidelines require two fundamental protections for research subjects: (1) individual voluntary informed consent, and (2) prior review of proposed research by an independent ethical review committee.3 These protections are necessary to ensure that the autonomy of research participants is respected, that volunteers consider the risks and benefits of participation, and that the benefits and burdens of research are equitably distributed.

A recent clinical trial of a vaccine designed to prevent the spread of Human Immunodeficiency Virus ("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.5 At the time of the research, injection drug users were subjected to coercive government programs in Thailand that did not exist in the United States.6 Given the study populations and social conditions in Thailand at the time of the study, it would have been more appropriate to conduct the research solely in the United States. When protocol review committees slavishly adhere to regulatory forms without properly considering substantive ethical issues and the local research context, inappropriate research may proceed. Approval by ethical review committees of HIV vaccine trials in Thailand represents one example of the form of legal and ethical analysis prevailing over substance.

If the United States and Thailand continue to collaborate in the search for an HIV vaccine, the protections for human subjects that are enforced in the United States must be equally robust when applied in Thailand. Part II of this Comment provides background information on the HIV clinical trials, and considers the ethical and legal implications of international biomedical research. Part III argues that U.S. regulations provide one source of protection to human subjects in Thailand, given the absence of Thai legislation. However, Part IV illustrates that in the case of the HIV vaccine clinical trials in Thailand, U.S. regulations governing informed consent were ineffectively applied. Part V suggests several approaches to strengthen existing protections for human subjects in future clinical trials.


Vaccines represent one possible way to curb the spread of HIV/AIDS. Most vaccines currently being explored in the context of HIV are preventive vaccines, which teach the body to recognize and defend itself against the viruses that cause the disease.7 Preventive vaccines cannot cure someone who has HIV or AIDS, but may prevent infection or slow the progression of HIV to AIDS.8 Clinical trials of vaccines are research studies in which new therapies for AIDS and HIV infection are tested in humans to assess whether the drugs or vaccines actually work as intended.9 Clinical trials of HIV vaccines progress through three phases. After a vaccine is shown to be safe in humans at a particular dosage level (Phase I), and initial evidence shows that it might be effective (Phase II), it may proceed to large-scale efficacy trials (Phase III).10

This Comment focuses on the challenges of conducting a Phase III HIV vaccine clinical trial. …

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