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

J Empir Res Hum Res Ethics. 2018 Jul;13(3):258-269. doi: 10.1177/1556264618771809. Epub 2018 May 13.

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,

Keywords: end of trial; equality; equity; ethics; vaccines.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Attitude*
  • Biomedical Research / ethics*
  • Child
  • Communication
  • Delivery of Health Care*
  • Ethics, Research
  • Ghana
  • Health Services
  • Humans
  • Information Dissemination
  • Malaria / prevention & control*
  • Malaria Vaccines*
  • Moral Obligations*
  • Pediatrics
  • Public Health
  • Stakeholder Participation*
  • Tanzania

Substances

  • Malaria Vaccines

Associated data

  • ClinicalTrials.gov/NCT00866619