Title Human challenge studies in endemic settings : ethical and regulatory issues / Euzebiusz Jamrozik, Michael J. Selgelid

Published Cham, Switzerland : Springer Open, [2021]

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Description 1 online resource Series SpringerBriefs in ethics, 2211-8101 SpringerBriefs in ethics. Contents 1. Introduction -- 2. Methods -- 3. History of human challenge studies -- 4. ethical issues -- 5. Community engagement, ethics review, and regulation -- 6. Case studies -- 7. Conclusions -- Acknowledgements Summary 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 Analysis Bioethics Infectious Diseases Vaccine Development and Health Moral Philosophy and Applied Ethics Internal Medicine Pharmacology Development Studies human challenge studies Open Access capacity building in low-income countries capacity building in middle-income countries malariotherapy intentional infection ethics of challenge studies challenge studies in endemic settings challenge studies and vulnerable populations Falciparum malaria challenge studies in Africa Infectious & contagious diseases Immunology Development studies Bibliography Includes bibliographical references Subject Clinical trials -- Moral and ethical aspects Clinical trials -- Law and legislation. Communicable diseases -- Research Human experimentation in medicine -- Moral and ethical aspects Clinical trials -- Law and legislation Clinical trials -- Moral and ethical aspects Communicable diseases -- Research Human experimentation in medicine -- Moral and ethical aspects Form Electronic book Author Selgelid, Michael J. ISBN 9783030414801 3030414809

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