Publication: Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh
Issued Date
2014
Resource Type
Language
eng
Rights
Mahidol University
Rights Holder(s)
BioMed Central
Bibliographic Citation
Malaria Journal. Vol.13, (2014), 217
Suggested Citation
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 Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh. Malaria Journal. Vol.13, (2014), 217. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/3074
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Thesis
Title
Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh
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