This open access book provides an extensive review of ethical and regulatory issues related to challenge studies, with a particular focus on the expansion of this type of research in low- and middle-income countries (LMICs). Human challenge studies (HCS) involving the intentional infection of research participants are increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to low- and middle-income countries LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of consensus and controversy. As the first volume to focus on ethical issues associated with human challenge studies, this book contributes to current debates in research ethics, informs regulatory policy, influences biomedical research practice, and sets the agenda for further work in this important area of global health research.weiterlesen