Abstract

Human challenge trials deliberately expose subjects to diseases upon consent to get more knowledge about the early stages of the disease and its transmission as well as to speed up testing of interventions. As human challenge studies are smaller, shorter and less expensive than other kinds of studies, by enabling a more efficient selection of vaccine candidates for further research and collection of significant data, they can imply relevant public health benefits. However, such studies are ethically sensitive because they are perceived encompassing high levels of risks both for participants and for third parties, which still encloses levels of uncertainty regarding these studies aftermaths. In this chapter, I will explore some HTCs’ pros and cons by presenting the main arguments of both positions with emphasis in some aspects of scientific and social value of the studies, risks for participants, risk minimization strategies, review, oversight, safety monitoring, follow up, policy and regulatory framework for these sort of trials.