Infectious Disease Challenge Studies: Ethical Issues In Causing Disease For Medical Knowledge

By Daniel Kavanagh, Ph.D., Currien MacDonald, MD, CIP, Lindsay McNair, MD, MPH, MSB

Infectious disease “challenge” studies, in which healthy participants are deliberately infected with pathogens to investigate the cause, prevention, and treatment of infectious diseases, hold great potential for delivering high-quality data about new interventions. Infectious challenge studies may be used to address a variety of scientific questions, such as demonstrating a causative role for a specific infectious agent in a particular disease, testing the ability of a drug to prevent or ameliorate disease, or testing the efficacy of a prophylactic vaccine.