Informed Consent and Community Engagement in Genomic Research

Abstract

The introduction of genomic research to, and emergence of biobanks in, sub-Saharan African countries raise ethical issues that require urgent attention. Firstly, there are concerns about whether individuals and communities would agree to participate in this type of research especially considering how communitarianism may affect their decision-making process. Secondly, there are controversies over whether the informed consent process as it is applied to other biomedical researches would be appropriate for genomic research in sub-Saharan Africa. And thirdly, the components of engagement of culturally distinct communities in genomic research are not yet clarified. Although community engagement during the recruitment stage have been described, there is dearth of information on effective strategies beyond this stage and which model is the most appropriate for sub-Saharan African settings. Therefore, my research explored the opinions of indigenous potential research participants on involvement in genomic research and to storage and export of their biospecimens, assessed the roles of community leadership in and perceptions of community engagement and informed consent processes in genomic research and biomedical researchers’ views. To obtain data for my qualitative study which is based on a methodological design adapted from grounded theory, I interviewed thirty biomedical researchers recruited from a research institution situated within the selected community, four community leaders and two community health workers; and conducted fifteen focus group sessions comprising 50 potential research participants organized by age and sex, namely: 1) adult (>30 years) males, 2) adult females, 3) youth (18-30 years) males, and 4) youth females. A mixed age-group was conducted to probe different views between the age groups. The data were transcribed verbatim and analyzed iteratively using constant comparative method to develop themes with the aid of Atlas-ti. The potential research participants would not agree to donation, storage or export of their samples unless they trusted the researchers to use their samples in an ethical manner, but the biomedical researchers felt that they would agree if the community leaders approved of the research. There was consensus between the adult research participants and the biomedical researchers on the appropriateness of blanket consent type for genomic research but the community leaders, health workers and the youths prefer either reconsenting or delegated consent. Married adult female participants would consult their husbands before agreeing to participate. All participants agreed on the gatekeeping role of the community leadership. The themes on community engagement reflected a strategic model of four stages, namely: community approach, community interphase, community integration, and post-research cordiality, as the crucial phases for ensuring effective community participation. There was discordance and clear division between the adults and youths regarding the decision to participate in genomic research based on commitment to communal values. Adults based their decision to participate on altruism and furthering the common good while youths based their decision on personal benefits and preferences and considered the views and welfare of family members and neighbours. This discordance suggests a generational shift, so I conceptualized a model of relative solidarity, which is different from communal solidarity typical of African communitarianism, for genomic research participation. To foster relational ethics, protect prospective research participants and ensure the success of genomic research, I proposed a strategic model of flow dynamics between the researcher(s), the community leaders, and potential research participants for effective community engagement. These findings suggest the need for a closer look at strategies for implementation of community engagement and informed consent in genomic research in this region. I recommend further studies on this emerging area of medical research.