Human Challenge Studies in Endemic Settings : (Record no. 306038)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05332nam a22004333i 4500 |
| 001 - CONTROL NUMBER | |
| control field | EBC6310312 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240122001231.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d | |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 231124s2020 xx o ||||0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783030414801 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9783030414795 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (MiAaPQ)EBC6310312 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (Au-PeEL)EBL6310312 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1243532476 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | MiAaPQ |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | MiAaPQ |
| Modifying agency | MiAaPQ |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | QH332 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Jamrozik, Euzebiusz. |
| 245 10 - TITLE STATEMENT | |
| Title | Human Challenge Studies in Endemic Settings : |
| Remainder of title | Ethical and Regulatory Issues. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Cham : |
| Name of producer, publisher, distributor, manufacturer | Springer International Publishing AG, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2020. |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | �2021. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (145 pages) |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | SpringerBriefs in Ethics Series |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 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. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Description based on publisher supplied metadata and other sources. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Electronic 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 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Selgelid, Michael J. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Jamrozik, Euzebiusz |
| Title | Human Challenge Studies in Endemic Settings |
| Place, publisher, and date of publication | Cham : Springer International Publishing AG,c2020 |
| International Standard Book Number | 9783030414795 |
| 797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN) | |
| Corporate name or jurisdiction name as entry element | ProQuest (Firm) |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | SpringerBriefs in Ethics Series |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=6310312">https://ebookcentral.proquest.com/lib/bacm-ebooks/detail.action?docID=6310312</a> |
| Public note | Click to View |
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