title: Ethical considerations in malaria research proposal review: empirical evidence from 114 proposals submitted to an Ethics Committee in Thailand.
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.
authors.affiliation: Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. pornpimon.ada@mahidol.ac.th.
authors.forename: Pornpimon
authors.initials: P
authors.lastname: Adams
authors.affiliation: Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. sukanya.pra@mahidol.ac.th.
authors.forename: Sukanya
authors.initials: S
authors.lastname: Prakobtham
authors.affiliation: Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. chantima.lim@mahidol.ac.th.
authors.forename: Chanthima
authors.initials: C
authors.lastname: Limphattharacharoen
authors.affiliation: Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. pitchapa.vut@mahidol.ac.th.
authors.forename: Pitchapa
authors.initials: P
authors.lastname: Vutikes
authors.affiliation: Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. srisin.khu@mahidol.ac.th.
authors.forename: Srisin
authors.initials: S
authors.lastname: Khusmith
authors.affiliation: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. krisana.pen@mahidol.ac.th.
authors.forename: Krisana
authors.initials: K
authors.lastname: Pengsaa
authors.affiliation: Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. polrat.wil@mahidol.ac.th.
authors.forename: Polrat
authors.initials: P
authors.lastname: Wilairatana
authors.affiliation: Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand. jaranit.kae@mahidol.ac.th.
authors.forename: Jaranit
authors.initials: J
authors.lastname: Kaewkungwal
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000706:statistics & numerical data*; D002648:Child; D003906:Developing Countries; D026724:Ethical Review; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D008288:Malaria; D011247:Pregnancy; D012107:Research Design / Q000706:statistics & numerical data*; D013785:Thailand