Improving Validity of Informed Consent for Biomedical Research in Zambia Using a Laboratory Exposure Intervention

Abstract

BackgroundComplex biomedical research can lead to disquiet in communities with limited exposure to scientific discussions, leading to rumours or to high drop-out rates. We set out to test an intervention designed to address apprehensions commonly encountered in a community where literacy is uncommon, and where complex biomedical research has been conducted for over a decade. We aimed to determine if it could improve the validity of consent.MethodsData were collected using focus group discussions, key informant interviews and observations. We designed an intervention that exposed participants to a detailed demonstration of laboratory processes. Each group was interviewed twice in a day, before and after exposure to the intervention in order to assess changes in their views.ResultsFactors that motivated people to participate in invasive biomedical research included a desire to stay healthy because of the screening during the recruitment process, regular advice from doctors, free medical services, and trust in the researchers. Inhibiting factors were limited knowledge about samples taken from their bodies during endoscopic procedures, the impact of endoscopy on the function of internal organs, and concerns about the use of biomedical samples. The belief that blood can be used for Satanic practices also created insecurities about drawing of blood samples. Further inhibiting factors included a fear of being labelled as HIV positive if known to consult heath workers repeatedly, and gender inequality. Concerns about the use and storage of blood and tissue samples were overcome by a laboratory exposure intervention.ConclusionSelecting a group of members from target community and engaging them in a laboratory exposure intervention could be a useful tool for enhancing specific aspects of consent for biomedical research. Further work is needed to determine the extent to which improved understanding permeates beyond the immediate group participating in the intervention.

Providing monetary and non-monetary goods to research participants: perspectives and practices of researchers and Research Ethics Committees in Zambia

“…Finally, a feeling among some researchers that offering goods to participants resulted in suspicion and mistrust between researchers and communities in Zambia must also be taken seriously. Misconceptions and suspicions of research seem to be a common occurrence in Zambia, as has been documented by others (Mwinga & Moodley, 2015;Zulu et al, 2014). Potential researchers in the country need to engage with this seemingly conflicting situation in which provision of goods has the potential to enhance collaborative partnerships and also contribute to mistrust.…”

“…The results suggest that, providing non-monetary offers (i.e. food offers, transportation, and educational materials) could be an important step in enhancing collaborative partnerships between researchers and communities, especially in the context of LMICs countries where monetary offers seem to evoke superstitions (Mwinga & Moodley, 2015;Zulu et al, 2014). Such collaborative partnerships are a necessary prerequisite for ethical research (Emanuel et al, 2004).…”

Impaired Barrier Function and Autoantibody Generation in Malnutrition Enteropathy in Zambia

“…HIV infected children were started on antiretroviral therapy before discharge from the ward. Adult volunteers were recruited in Misisi, Lusaka, using a 3-stage consent process as previously described ( Zulu et al, 2014 ). Children in the community were identified during the course of a community malnutrition screening programme ( Amadi et al, 2016 ) and caregivers provided written informed consent to join the study.…”

Ethical challenges in research on post-abortion care with adolescents: experiences of researchers in Zambia

“…To address many of the ethical challenges experienced by researchers who conduct PAC research with adolescents, it may be appropriate to adopt an "ecological approach" as the barriers to PAC research in Zambia exist at various levels. This approach stresses developing strategies that simultaneously address issues at individual, family, community, societal and institutional levels (Kumwenda, Nzala, & Zulu, 2017;Svanemyr, Amin, Robles, & Greene, 2015;Zulu et al, 2018;Zulu, Lisulo, et al, 2014;. Using the ecological approach would, for example, entail developing effective communication strategies that target dissemination of information regarding the grounds for legal abortion to adolescents, families, communities, IRBs and institutions more generally, such as the Ministry of Health.…”