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Title: Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh
Authors: Debashish Das
Cheah, Phaik Yeong
Fateha Akter
Dulal Paul
Akhterul Islam
Rasheda Samad
Ridwanur Rahman
Amir Hossain
Arjen Dondorp
Day, Nicholas P
White, Nicholas J
Mahtabuddin Hasan
Aniruddha Ghose
Ashley, Elizabeth A
Abul Faiz
Mahidol University. Faculty of Tropical Medicine. Mahidol-Oxford Tropical Medicine Research Unit
Keywords: Open Access article;Consent;Ethics;Clinical trials;Bangladesh;Malaria
Issue Date: 2014
Citation: Malaria Journal. Vol.13, (2014), 217
Abstract: Background: Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods: In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Results: Of 16 participants, the vast majority (81%) were illiterate. All subjects had a ‘therapeutic misconception’ i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients’ perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants’ satisfaction with treatment and nursing care. Conclusion: There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings
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