001430853 000__ 03699cam\a2200565\a\4500 001430853 001__ 1430853 001430853 003__ OCoLC 001430853 005__ 20230308003209.0 001430853 006__ m\\\\\o\\d\\\\\\\\ 001430853 007__ cr\un\nnnunnun 001430853 008__ 200904s2021\\\\sz\\\\\\ob\\\\000\0\eng\d 001430853 020__ $$a9783030414801$$q(electronic bk.) 001430853 020__ $$a3030414809$$q(electronic bk.) 001430853 020__ $$z3030414795 001430853 020__ $$z9783030414795 001430853 0247_ $$a10.1007/978-3-030-41480-1$$2doi 001430853 035__ $$aSP(OCoLC)1192491583 001430853 040__ $$aYDX$$beng$$epn$$cYDX$$dGW5XE$$dOCLCF$$dNLW$$dSFB$$dOCLCQ$$dOCLCO$$dOCLCQ$$dYWS 001430853 049__ $$aISEA 001430853 050_4 $$aR853.C55 001430853 08204 $$a174.2/8$$223 001430853 1001_ $$aJamrozik, Euzebiusz. 001430853 24510 $$aHuman challenge studies in endemic settings :$$bethical and regulatory issues /$$cEuzebiusz Jamrozik, Michael J. Selgelid. 001430853 260__ $$aCham, Switzerland :$$bSpringer Open,$$c[2021] 001430853 300__ $$a1 online resource 001430853 336__ $$atext$$btxt$$2rdacontent 001430853 337__ $$acomputer$$bc$$2rdamedia 001430853 338__ $$aonline resource$$bcr$$2rdacarrier 001430853 4901_ $$aSpringerBriefs in ethics,$$x2211-8101 001430853 504__ $$aIncludes bibliographical references. 001430853 5050_ $$a1. 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. 001430853 5060_ $$aOpen access.$$5GW5XE 001430853 520__ $$aThis open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19. 001430853 650_0 $$aClinical trials$$xMoral and ethical aspects. 001430853 650_0 $$aClinical trials$$xLaw and legislation. 001430853 650_0 $$aCommunicable diseases$$xResearch. 001430853 650_0 $$aHuman experimentation in medicine$$xMoral and ethical aspects. 001430853 650_6 $$aÉtudes cliniques$$xAspect moral. 001430853 650_6 $$aMaladies infectieuses$$xRecherche. 001430853 650_6 $$aExpérimentation humaine en médecine$$xAspect moral. 001430853 655_0 $$aElectronic books. 001430853 7001_ $$aSelgelid, Michael J. 001430853 77608 $$iPrint version:$$aJamrozik, Euzebiusz.$$tHuman challenge studies in endemic settings.$$dCham, Switzerland : Springer Open, [2021]$$z3030414795$$z9783030414795$$w(OCoLC)1137833914 001430853 830_0 $$aSpringerBriefs in ethics. 001430853 852__ $$bebk 001430853 85640 $$3Springer Nature$$uhttps://link.springer.com/10.1007/978-3-030-41480-1$$zOnline Access$$91397441.2 001430853 909CO $$ooai:library.usi.edu:1430853$$pGLOBAL_SET 001430853 980__ $$aBIB 001430853 980__ $$aEBOOK 001430853 982__ $$aEbook 001430853 983__ $$aOnline 001430853 994__ $$a92$$bISE