The Ethics of Health Care Delivery in a Pediatric Malaria Vaccine Trial: The Perspectives of Stakeholders From Ghana and Tanzania.
This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk-benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.
['Ward|Claire Leonie|CL|', 'Shaw|David|D|', 'Anane-Sarpong|Evelyn|E|', 'Sankoh|Osman|O|', 'Tanner|Marcel|M|', 'Elger|Bernice|B|']
D001290:Attitude D035843:Biomedical Research D002675:Child, Preschool D003695:Delivery of Health Care D003906:Developing Countries D026690:Ethics, Clinical D032984:Ethics, Research D005869:Ghana D006295:Health Resources D006296:Health Services D006801:Humans D007223:Infant D008288:Malaria D017780:Malaria Vaccines D009042:Motivation D010372:Pediatrics D011203:Poverty D012107:Research Design D012111:Residence Characteristics D000073597:Stakeholder Participation D013636:Tanzania D055990:Therapeutic Misconception
ethics vaccines undue inducement disparity therapeutic misconception