Clinical trials require high levels of participation and low drop-out rates to be successful. Collecting blood samples from individuals recruited into clinical trials can be challenging when there is concerns about blood-taking. In addition to concerns regarding the feasibility of medical research, fears of 'blood-stealing' and 'blood-selling' have ethical implications related to cultural sensitivity and informed consent.
Results from our recent study which explores anxieties around blood-taking during a malaria treatment trial in The Gambia, shows that misunderstandings and emerging rumours can greatly hinder trial participation. This study was done in collaboration with the medical anthropology group at the Institute of Tropical Medicine, Antwerp. The results which emerge from this study is based on ethnographic research in one village selected because of the high reticence to screening for the clinical trial “Primaquine's gametocytocidal efficacy in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine’ study.”

This study was conducted in The Gambia between 2013 and 2014, funded by the Joint Global Health Trials Scheme (DFID/MRC/Wellcome Trust) lead by Prof Umberto D’Alessandro. Data collection tools included in-depth interviews, participant observation, informal conversations and group discussions. Although the trial recruitment was initially high in the village, some families refused screening when rumours started spreading that the trial team was taking too much blood. Concerns about 'loss of blood' were equated to loss of strength and lack of good food to replenish bodily forces. Families in the study village were concerned about the weakness of their body while they had to harvest their crops at the time of recruitment for the trial.

When asked about how these challenges were overcome, Prof Umberto D’Alessandro, Unit Director said ”We know that collecting blood samples for research has always been difficult, though we always try to explain very carefully to all potential study participants the reason for collecting blood  samples. It is extremely important to understand their anxieties and provide them with as much information as possible. Eventually, a potential study participant should be able to freely choose whether to participate in a research project but such decision should be based on correct information. This study will help us to better address this issue. ”

Thus, results from our case study recommends the provision of full and consistent information during the consent procedure, which is assumed to lead to more accurate knowledge of the purpose of the intervention and increased trial participation.

Acknowledgments

We thank the study participants from the Fulani village and MRCG staff for their kind assistance with this study. The main author thanks the Institute of Social Cultural Anthropology at the University of Oxford, Oxford, UK for the visiting fellowship.

More: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0160464 

Authors: Sarah O’Neill, Susan Dierickx, Joseph Okebe, Edgard Dabira, Charlotte Gryseels, Umberto D’Alessandro, Koen Peeters Grietens