Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh

Abstract

BackgroundExisting 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.MethodsIn this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh.ResultsOf 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.ConclusionThere 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.

Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand

“…They said that they had been provided with enough information, but we found that some did not clearly understand data sharing or had difficulty recalling the information provided about data sharing. This finding is congruent with an earlier empirical study on understandings of consent in our setting, where many respondents commented that they could not remember or understand everything that was explained to them about research [ 15 ]. We also found that the words “data”, “sharing” and “data sharing”, as we understand them in this context, and as they were translated into Thai, were not immediately understood by the clinical trial participants, and as a consequence they exhibited a wide range of interpretations of data sharing.…”

“…When recruiting participants into research, data sharing is yet one more piece of information to add to the twenty elements that Good Clinical Practice (GCP) guidelines stipulate should be provided about a healthcare study [ 41 ]. A study we conducted in Bangladesh showed that including all the GCP-required items in the information sheet did not lead to “informed” consent [ 15 ]. Empirical research in other LMIC settings also demonstrate that challenges arise when seeking appropriately informed consent [ 16 , 17 ].…”

“…However, to date there have been few empirical investigations into best practices in seeking broad consent for data sharing in LMICs, including considerations of how much information to provide to research participants and how best to explain concepts comprehensibly. Our experience, and the experience of others conducting research in LMICs shows that research participants often do not comprehend some aspects of research, including abstract and unfamiliar concepts [ 15 – 18 ].…”

Maximizing research study effectiveness in malaria elimination settings: a mixed methods study to capture the experiences of field-based staff

“…Malaria research in resource-poor settings often involves an overlap between research and clinical care [ 39 ]. Field research teams are often composed of health workers providing care to the community, such as the Pailin Referral Hospital employees and the VMWs who participated in this study.…”

Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda

“…From our experience conducting studies in low-income settings, participants rarely fully comprehend the information in the primary studies (Das et al 2014 ). Data sharing is a concept that is removed from the daily lives of many of our participants.…”