1. The Ethics of End-of-Trial Obligations in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania.
- Author
-
Ward CL, Shaw D, Anane-Sarpong E, Sankoh O, Tanner M, and Elger B
- Subjects
- Child, Communication, Ethics, Research, Ghana, Health Services, Humans, Information Dissemination, Pediatrics, Public Health, Tanzania, Attitude, Biomedical Research ethics, Delivery of Health Care, Malaria prevention & control, Malaria Vaccines, Moral Obligations, Stakeholder Participation
- 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.)
- Published
- 2018
- Full Text
- View/download PDF