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The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of... This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) (NCT00866619]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system, (c) design a gradual exit strategy with opportunities to address unplanned events, (d) endorse a principled approach of continuity of care when designing a health care service handover, and (e) devise an actionable post-trial treatment access pathway with diverse stakeholder representatives. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Empirical Research on Human Research Ethics SAGE

The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania

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Publisher
SAGE
Copyright
© The Author(s) 2018
ISSN
1556-2646
eISSN
1556-2654
DOI
10.1177/1556264618771809
Publisher site
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Abstract

This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) (NCT00866619]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system, (c) design a gradual exit strategy with opportunities to address unplanned events, (d) endorse a principled approach of continuity of care when designing a health care service handover, and (e) devise an actionable post-trial treatment access pathway with diverse stakeholder representatives.

Journal

Journal of Empirical Research on Human Research Ethics – SAGE

Published: Jul 1, 2018

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