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.