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

Bibliographic Details
Main Author: Jamrozik, Euzebiusz.
Other Authors: Selgelid, Michael J.
Format: eBook
Language:English
Published: Cham : Springer International Publishing AG, 2020.
Edition:1st ed.
Series:SpringerBriefs in Ethics Series
Subjects:
Electronic books.
Online Access:Click to View
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.

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