Human Challenge Studies in Endemic Settings : : Ethical and Regulatory Issues.
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Superior document: | SpringerBriefs in Ethics Series |
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TeilnehmendeR: | |
Place / Publishing House: | Cham : : Springer International Publishing AG,, 2020. ©2021. |
Year of Publication: | 2020 |
Edition: | 1st ed. |
Language: | English |
Series: | SpringerBriefs in Ethics Series
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Online Access: | |
Physical Description: | 1 online resource (145 pages) |
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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.