Publication: Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand
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Issued Date
2015
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eng
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Mahidol University
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BioMed Central
Bibliographic Citation
Malar Journal. Vol.14, (2015), 342
Suggested Citation
Pornpimon Adams, Sukanya Prakobtham, Chanthima Limphattharacharoen, Pitchapa Vutikes, Srisin Khusmith, Krisana Pengsaa, Polrat Wilairatana, Jaranit Kaewkungwal Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand. Malar Journal. Vol.14, (2015), 342. doi:10.1186/s12936-015-0854-5 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/3079
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Title
Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand
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Abstract
Background: Malaria 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.
Methods: Proposals 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.
Results: All 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.
Conclusions: This 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.