There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and (...) informed consent process. The pilot was implemented in two schools and examined the acceptability of a package of interventions including economic support to families to keep their girls in school, pocket money for girls, youth club meetings on reproductive health, and community meetings to sensitize the community. Focus group discussions were conducted with girls who participated in the pilot, boys in their class and with parents. Individual semi-structured interviews were conducted with teachers, peer educators and community health workers involved in the coordination of the intervention as well as with religious and traditional leaders. Data were analyzed through thematic analysis. The findings indicate that inadequate use of recognized community communication channels during the community engagement process and dissemination of information about the pilot resulted in limited understanding of the pilot concept by the community. This surfaced through uncertainty and fear that the intervention may result in loss of control over daughters, worries about why money was provided unconditionally to girls, and suspicion of links to satanism. The sense of insecurity appeared to be exacerbated by low literacy levels, poverty, fear of loss of bride wealth, perceived disregard for local perceptions of social status, and scanty trust in the actors implementing the pilot. Inadequate use of locally appropriate channels in the dissemination of information created room for interpretation and facilitated development of mistrust, undermining the conditions for community engagement and actual informed consent. A key lesson learnt is the importance of taking seriously the complexity of local values and structures that may impact people’s capability to consent or not consent to a study in an informed manner. (shrink)

ABSTRACT Post-abortion care (PAC) research is increasingly being conducted in low- and middle-income countries (LMICs) to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma (...) around abortion and community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

One important ethical issue in randomised controlled trials is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. In this explorative study, in-depth semi-structured interviews (...) were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a “lottery” because they wanted all schools to receive equal or balanced benefits of the interventions. Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials should consider carefully how to explain randomisation. (shrink)

Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and (...) community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)