The Ethical Conduct of Clinical Trials of HIV Vaccines

Abstract

Clinical trials of candidate HIV vaccines pose virtually all of the problems possible in vaccine trials. Resolving them consistently with accepted ethical principles is likely to make trials logistically more difficult, longer, and more expensive than usual. Yet few of these problems are unique to HIV vaccines. What is unique are the social risks that research subjects may face. The major obstacles to testing vaccine candidates in human beings are the same ones that have hindered vaccine development-insufficient knowledge about the virus and the human immune response. The necessarily urgent search for a vaccine to prevent HIV infection does not require subjecting people to unnecessary risks. This article outlines key ethical obstacles to identifying candidate vaccines to test, with special attention to clarifying the benefits and risks of testing experimental vaccines in healthy research subjects. Assuming that such obstacles can be overcome, the article examines how ethical principles governing biomedical research may apply to the design and conduct of clinical trials to ensure independent review of proposed research, identify measures of vaccine effectiveness, identify and monitor suitable research subjects, provide adequate counseling, protect confidential information, and assure compensation for injury and access to any successful vaccine.