Human Challenge Studies in Endemic Settings : : Ethical and Regulatory Issues.

• Superior document: SpringerBriefs in Ethics Series
• Author: Jamrozik, Euzebiusz.
• TeilnehmendeR: Selgelid, Michael J.
• Place / Publishing House: Cham : : Springer International Publishing AG,, 2020.; ©2021.
• Year of Publication: 2020
• Edition: 1st ed.
• Language: English
• Series: SpringerBriefs in Ethics Series
• Physical Description: 1 online resource (145 pages)

Table of Contents

Intro -- 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.

4.3.3 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.