Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand

Abstract

BackgroundMalaria research is typically conducted in developing countries in areas of endemic disease. This raises specific ethical issues, including those related to local cultural concepts of health and disease, the educational background of study subjects, and principles of justice at the community and country level. Research Ethics Committees (RECs) are responsible for regulating the ethical conduct of research, but questions have been raised whether RECs facilitate or impede research, and about the quality of REC review itself. This study examines the review process for malaria research proposals submitted to the Ethics Committee of the Faculty of Tropical Medicine at Mahidol University, Thailand.MethodsProposals for all studies submitted for review from January 2010 to December 2014 were included. Individual REC members’ reviewing forms were evaluated. Ethical issues (e.g., scientific merit, risk–benefit, sample size, or informed-consent) raised in the forms were counted and analysed according to characteristics, including study classification/design, use of specimens, study site, and study population.ResultsAll 114 proposals submitted during the study period were analysed, comprising biomedical studies (17 %), drug trials (13 %), laboratory studies (24 %) and epidemiological studies (46 %). They included multi-site (13 %) and international studies (4 %), and those involving minority populations (28 %), children (17 %) and pregnant women (7 %). Drug trials had the highest proportion of questions raised for most ethical issues, while issues concerning privacy and confidentiality tended to be highest for laboratory and epidemiology studies. Clarifications on ethical issues were requested by the ethics committee more for proposals involving new specimen collection. Studies involving stored data and specimens tended to attract more issues around privacy and confidentiality. Proposals involving minority populations were more likely to raise issues than those that did not. Those involving vulnerable populations were more likely to attract concerns related to study rationale and design.ConclusionsThis study stratified ethical issues raised in a broad spectrum of research proposals. The Faculty of Tropical Medicine at Mahidol University is a significant contributor to global malaria research output. The findings shed light on the ethical review process that may be useful for stakeholders, including researchers, RECs and sponsors, conducting malaria research in other endemic settings.

Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review

“…Most studies reported that ethical issues were especially common in clinical trials, including in the ethical review process, standard of care, incentives and reimbursement, and insurance and indemnity [ 17 – 20 ]. A previous study stratified the ethical issues raised in a broad spectrum of research proposals submitted to the Faculty of Tropical Medicine Ethics Committee (FTM-EC) at Mahidol University [ 20 ]. The findings of the study described ethical considerations in the review process, but did not focus on ICP issues.…”

“…The findings of the study described ethical considerations in the review process, but did not focus on ICP issues. The ICP is particularly critical in studies that use new or linked specimens or data in human research subjects, and deficits in the ICP are often identified in a REC review [ 20 – 22 ]. This study focused particularly on ICP in malaria research, since (a) about one-third of proposals submitted to FTM-EC were related to malaria and FTM has been one of the institutes contributing significantly to global research publication on malaria, and (b) ICP in malaria research is crucial as malaria studies are generally conducted among the vulnerable, including children, ethnic groups, refugee and cross-border populations, who are mostly illiterate and reside in remote, limited healthcare-access and/or low-resource settings.…”