@article{1430853,
      recid = {1430853},
      author = {Jamrozik, Euzebiusz. and Selgelid, Michael J.},
      title = {Human challenge studies in endemic settings : ethical and  regulatory issues /},
      publisher = {Springer Open,},
      address = {Cham, Switzerland :},
      pages = {1 online resource},
      year = {2021},
      abstract = {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.},
      url = {http://library.usi.edu/record/1430853},
      doi = {https://doi.org/10.1007/978-3-030-41480-1},
}