Domestic AIDS Vaccine Trials: Addressing the Potential for Social Harm to the Subjects of Human Experiments

Abstract

In 1998, the FDA approved the first large-scale human trials of a candidate AIDS vaccine in our nation's history. While the legal issues raised by these trials are manifold, the academic literature has focused almost exclusively on the potential for mass tort liability and the resulting hesitancy of biotech and pharmaceutical firms to enter the field. This Comment argues that another issue of vital concern demands attention: the potential for social harm to the human subjects of AIDS vaccine trials. After providing an overview of the current epidemiology of HIV/AIDS and explaining why a safe, effective AIDS vaccine represents the best way to control the pandemic, this Comment analyzes the scientific and social obstacles to production of such a vaccine. In order to know whether a candidate AIDS vaccine is truly effective, researchers will have to test the product in HIV-negative volunteers at high risk of infection. Since these volunteers may subsequently test positive for HIV on standard blood tests, they will be vulnerable to discrimination on that basis in such areas as employment, insurance, immigration, and incarceration. Moreover, by participating in vaccine trials, volunteers will be marking themselves as people at high risk of HIV infection, another basis for disparate treatment. Researchers have suggested that federal disability discrimination law may afford protection against research-related social harms. Through close analysis of the Americans with Disabilities Act of 1990 and the Supreme Court's decision in Bragdon v. Abbott, this Comment demonstrates that optimistic reliance on federal disability law is misplaced. The unique issues raised by domestic AIDS vaccine trials must be addressed in their own right. The Comment accordingly concludes with a broad range of legislative and regulatory proposals to protect trial participants and advance the AIDS vaccine research agenda.