Infectious disease experimentation involving human volunteers

Abstract

The current care of patients with infectious diseases owes a tremendous debt to healthy volunteers who allowed investigators to induce disease in them for the study of transmission, natural history, and treatment. We reviewed the English-language medical literature about the rarely discussed subject of the use of healthy volunteers in human-subject research in infectious diseases to determine the contributions of these experiments to the current understanding of disease transmission. The literature review focused on hepatitis, upper respiratory infections, and malaria, which represent the array of issues involved in this type of research. Researchers successfully induced infection through injecting, nebulizing, and feeding specimens to thousands of volunteers, who included authentic volunteers as well as soldiers and imprisoned subjects. These volunteers often undertook unforeseen and unpredictable risks during these experiments for the benefit of others. Future research in these areas must strike an adequate balance between the risks to participants and the benefits to society.