Using iterative learning to improve understanding during the informed consent process in a South African psychiatric genomics study.

Equity in Global Health Research.

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.

In global health research and genomics research specifically, community engagement has gained prominence in enhancing ethical conduct, particularly in managing the risk of stigmatization, but there is minimal scientific evidence on how to do this effectively. This article reports on community engagement evaluation strategies in two African genomics studies: the Stigma in African Genomics Research study and the Genomics of Schizophrenia in South African Xhosa People (SAX) study. Within the Stigma in African Genomics Research study, a self-report rating scale and open-ended questions were used to track participant responses to an experiential theatre workshop. The workshop focused on participant experiences of living with schizophrenia or rheumatic heart disease (RHD). While the schizophrenia group reported more alienation and less stigma resistance than the RHD group, both groups demonstrated increased stigma resistance over time, after participating in the workshops. Hearing from others living with and managing the same illness normalised participants' own experiences and encouraged them. Within the SAX study, a short rating scale and qualitative feedback methods were used to evaluate a Mental Health Literacy Day targeting mental health stigma. Information talks about (i) the symptoms of schizophrenia and treatment options and (ii) the illness experiences of a patient in recovery were rated as the most helpful on the day. Audience members reported that these talks challenged negative perceptions about severe mental illness. Three important learnings emerged from these evaluations: firstly, integration of evaluation strategies at the research study planning phase is likely to promote more effective community engagement. Secondly, a combination of quantitative and qualitative methods that draw on simple descriptive statistics and thematic analysis can provide nuanced perspectives about the value of community engagement. Thirdly, such evidence is necessary in establishing and promoting the science of community engagement in genomics research and health research more broadly.

BackgroundCell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during this consent process?Methods760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent.ResultsApproximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape (as opposed to the Western Cape), and older participants (aged between 40 and 59 years), were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness (schizophrenia vs control) nor education (primary vs secondary school) were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit.ConclusionsThese findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies.

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1 Netherlands Society for Tropical Medicine and International Health (NVTG), Wageningen, The Netherlands 1 2 Institute for Medical Technology Assessment, ErasmusMC, Rotterdam, The Netherlands 3 Department of Public Health, University Medical Centre Nijmegen, Nijmegen, The Netherlands 4 ETC Crystal, Leusden, The Netherlands 5 Institute of Health Policy and Management, ErasmusMC, Rotterdam, The Netherlands

Confirming comprehension of informed consent as a protection of human subjects

Community-based participatory research (CBPR) and participatory action research (PAR) methodologies incorporate community engagement throughout the research process to reduce health inequities, support research capacity, and ensure that research supports community goals. To foster true reciprocity between academic institutions and community members, ethics training required by academic institutions should be culturally and linguistically adapted to partnering communities in low- and middle-income countries (LMICs). Current ethics resources have been adapted for non-academic populations. However, these ethics resources do not yet effectively allow community researchers in LMICs to develop their own framework or tailor trainings to their specific communities. A framework guiding the adaptation of ethics training methods specific to conducting CBPR and PAR in LMICs is necessary in developing research capacity in LMICs. Such adaptive ethics training models could also be beneficial for research conducted among marginalized populations in HICs.

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board (CAB) is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants.

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BackgroundA requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.AimsThe aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.MethodsIn an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process.ResultsIn total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location.ConclusionsThe findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.