This open access book provides an extensive review of ethical and regulatory issues related to
human infection challenge studies with a particular focus on the expansion of this type of
research into endemic settings and or low- and middle-income countries (LMICs). Human challenge
studies (HCS) involve the intentional infection of research participants and this type of
research is rapidly increasing in frequency worldwide. HCS are widely considered to be an
especially promising approach to vaccine development including for pathogens endemic to LMICs.
However challenge studies are sometimes controversial and raise complex ethical issues some
of which are especially salient in endemic and or LMIC settings. Informed by qualitative
interviews with experts in infectious diseases and bioethics this book highlights areas of
ethical consensus and controversy concerning this kind of research. As the first volume to
focus on ethical issues associated with human challenge studies it sets the agenda for further
work in this important area of global health research contributes to current debates in
research ethics and aims to inform regulatory policy and research practice. Insofar as it
focuses on HCS in (endemic) settings where diseases are present and or widespread much of the
analysis provided here is directly relevant to HCS involving pandemic diseases including
COVID19.
