000			05332nam a22004333i 4500
001			EBC6310312
003			MiAaPQ
005			20240122001231.0
006			m o d |
007			cr cnu||||||||
008			231124s2020 xx o ||||0 eng d
020			_a9783030414801 _q(electronic bk.)
020			_z9783030414795
035			_a(MiAaPQ)EBC6310312
035			_a(Au-PeEL)EBL6310312
035			_a(OCoLC)1243532476
040			_aMiAaPQ _beng _erda _epn _cMiAaPQ _dMiAaPQ
050		4	_aQH332
100	1		_aJamrozik, Euzebiusz.
245	1	0	_aHuman Challenge Studies in Endemic Settings : _bEthical and Regulatory Issues.
250			_a1st ed.
264		1	_aCham : _bSpringer International Publishing AG, _c2020.
264		4	_c�2021.
300			_a1 online resource (145 pages)
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
490	1		_aSpringerBriefs in Ethics Series
505	0		_aIntro -- Preface -- Acknowledgments -- Executive Summary -- Background -- Key Points of Consensus -- Unresolved Issues -- Conclusion -- Contents -- 1 Introduction -- 1.1 Focus of This Report -- 1.2 Methods -- 1.2.1 Literature Review -- 1.2.2 Qualitative Interviews -- 1.2.3 Synthesis and Validity Checking -- References -- 2 History of Human Challenge Studies -- 2.1 Experimental Infection in the 18th-19th Century -- 2.2 Early Challenge Studies with Vector-Borne Diseases -- 2.3 Malariotherapy -- 2.4 Infamous 20th Century Cases and the Rise of Modern Research Ethics -- 2.5 Late 20th Century -- 2.6 Capacity Building in Low- and Middle-Income Countries -- References -- 3 Ethical Issues -- 3.1 Intentional Infection -- 3.2 Benefits -- 3.2.1 Scientific Rationale and Social Value -- 3.2.2 Benefit Sharing -- 3.2.3 Capacity Building -- 3.2.4 Potential Individual Benefits of Participation in Endemic Settings -- 3.3 Burdens for Participants -- 3.3.1 Limits to Risk -- 3.3.2 Minimising Risks -- 3.3.3 Risks to Participants in Endemic Settings -- 3.3.4 Long-Term Risks and Lasting Harms -- 3.3.5 Uncertainty -- 3.3.6 Other Burdens for Participants -- 3.3.7 Participant Behaviour -- 3.4 Risks to Third Parties -- 3.4.1 Third-Party Risks and Studies of Transmissibility -- 3.5 Participant Selection -- 3.5.1 Vulnerable Populations in Human Challenge Studies -- 3.5.2 Consent -- 3.5.3 Education Level -- 3.5.4 Children -- 3.6 Payment of Participants -- 3.6.1 Undue Inducement -- 3.6.2 Other Ethical Issues Related to Payment -- References -- 4 Community Engagement, Ethics Review, and Regulation -- 4.1 Community Engagement -- 4.2 Ethical Review -- 4.2.1 Ethical Frameworks for Human Challenge Studies -- 4.2.2 Potential Models for Special Ethical Review -- 4.3 Regulation -- 4.3.1 International Regulations -- 4.3.2 Regulating Challenge Strains.
505	8		_a4.3.3 Challenge Studies and Licensure of New Interventions -- 4.3.4 Regulation of Over-Volunteering -- 4.3.5 Laws Criminalising Intentional Infection -- References -- 5 Case Studies: Challenge Studies in Low- and Middle-Income Countries -- 5.1 Cholera and Shigella Challenge Studies in Thailand -- 5.1.1 Rationale and Review Process -- 5.1.2 Recruitment, Participant Selection, Consent, and Payment -- 5.1.3 Burdens (Including Risks to Participants and Third Parties) -- 5.1.4 Summary and Outcomes -- 5.2 Falciparum Malaria Challenge Studies in Africa -- 5.2.1 Rationale and Review Process -- 5.2.2 Recruitment, Participant Selection, Consent, and Payment -- 5.2.3 Burdens (Including Risks to Participants and Third Parties) -- 5.2.4 Summary and Outcomes -- 5.3 Vivax Malaria Challenge Studies in Colombia -- 5.3.1 Rationale and Review Process -- 5.3.2 Recruitment, Participant Selection, Consent, and Payment -- 5.3.3 Burdens (Including Risks to Participants and Third Parties) -- 5.3.4 Summary and Outcomes -- 5.4 Summary of Case Studies -- 5.4.1 Rationale and Review Process -- 5.4.2 Recruitment, Participant Selection, Consent, and Payment -- 5.4.3 Burdens (Including Risks to Participants and Third Parties) -- References -- 6 Conclusions -- 6.1 Lessons Learned to Date -- 6.2 Points of Consensus -- 6.3 Controversies and Unresolved Issues -- 6.3.1 Burdens and Benefits -- 6.3.2 Participant Selection and Payment -- 6.3.3 Governance -- 6.4 Future Directions -- References.
588			_aDescription based on publisher supplied metadata and other sources.
590			_aElectronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2023. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
655		4	_aElectronic books.
700	1		_aSelgelid, Michael J.
776	0	8	_iPrint version: _aJamrozik, Euzebiusz _tHuman Challenge Studies in Endemic Settings _dCham : Springer International Publishing AG,c2020 _z9783030414795
797	2		_aProQuest (Firm)
830		0	_aSpringerBriefs in Ethics Series
856	4	0	_uhttps://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=6310312 _zClick to View
999			_c306038 _d306038