Browsing by Author "De Vries, Jantina"

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    Open Access
    Developing a Principles-Based Framework to Link the Governance of Genomics Research and Biobanking in Africa to Global Health Justice
    (2019) Munung, Nchangwi Syntia; De Vries, Jantina; Pratt, Bridget
    Background Genomics research has introduced significant transformations in the way health research is traditionally structured. Firstly, genomics research often requires long-term storage of biological samples for future unspecified uses. Secondly, the stored samples may be shared with researchers across the globe for the purposes of research. Thirdly, genomics researchers are increasingly required to make their research data publicly available for use by other researchers and institutions from around the world. Whilst data and sample sharing offers significant benefits for global health research, in Africa, it is taking place amidst a background of:structural inequities in health and health research between Africa and High Income Countries (HICs). There are also concerns around the exploitation of African researchers and study populations, mainly hinged on historical experiences in global health research, what has been termed scientific imperialism or “extractive” research. It is therefore not surprising that the rise in genomics research and biobanking studies in Africa has been accompanied by strong calls to address the ethical legal and social issues (ELSIs) raised by genomics research and biobanking in Africa. Some of these ELSIs focus on individual-level issues (micro-justice), others go beyond that to include broader societal ELSIs (macro-level justice) such as: secondary access to samples and data, benefit sharing, exploitation of African researchers and populations, intellectual property and the ownership of samples and data. One way of addressing these macro-level justice-related ELSIs is through governance. Aim and Objectives The aim of this study isto develop a governance framework that could be used to address macrolevel-justice-ELSIs in genomics research and biobanking in Africa. To achieve this aim, I put forth the following specific objectives: 1. To identify principles, values and norms that could promote justice and fairness in genomics research and biobanking in Africa; 2. To develop a principles-based governance framework for genomics research and biobanking in Africa that links its policies to the promotion of justice; 3. To investigate how the governance of current day genomics research and biobanking projects in Africa have considered concerns of justice and fairness; 4. To explore the views of key stakeholders on fair and just governance mechanisms for genomics research and biobanking in Africa. Methodology To develop the governance framework, I used the normative practice-oriented bioethics (NPOB) approach. This required adopting a number of methodologies, both conceptual and empirical. The conceptual work used the convergence approach and consisted of a theoretical analysis of two theories of global health justice, namely: shared health governance (by Jennifer Ruger) and global governance for health (by Larry Gostin); as well as the African philosophy of Ubuntu. Through the conceptual and normative analysis, I identified a number of principles that could inform the governance of genomicsresearch and biobanking in Africa. These principles were used to propose a governance framework that could address macro-level justice ELSIs in genomics research and biobanking programs in Africa. Following the development of the governance framework, we used empirical bioethics research methods to probe whether and how the framework’s principles could be practically promoted in genomics research and biobanking consortia in Africa and to revise the framework where necessary. To do this, I used the reflective equilibrium approach. This included checking the proposed framework’s principles and recommendations against current governance practices of a genomics research consortia in Africa as well as well as prompting various stakeholders to think of how these principles could be applied in practice, or how the have been applied within genomics research consortia in Africa. Using the Human Heredity and Health in Africa (H3Africa) Consortium as a case study, as well as two qualitative research methods: content analysis of H3Africa governance documents and one-on-one in-depth interviews (n=15), I checked the framework’s principles against the empirical data and revised as, and when necessary (reflective equilibrium). Results The conceptual analysis led to the identification of the following nine principles: solidarity, reciprocity, furthering the ideals of health justice (FIHJ), shared sovereignty, shared resources, transparency, shared responsibility; mutual trust and mutual collective accountability. These principles were used to develop a principles-based governance framework for genomicsresearch and biobanking. Because I wanted develop a governance framework that is practically implementable, I made recommendations on how each principle could be actualised genomics research in Africa. Analysis of the empirical data showed that the majority of the framework’s principles and or recommendations were being promoted or prioritized by H3Africa ELSI governance. Equally, many H3Africa the principles and recommendations were considered by various H3Africa stakeholders to be critical in promoting justice and fairness in genomics research and biobanking projects in Africa. This suggests that our framework’s requirements are not just theoretical but could be implemented in practice and that there was some buy-in by stakeholders involved in genomics projects in Africa. A key area of deviation between the principles-based framework and the empirical data was the involvement of study populations in decision making (e.g. decision making on sample and data use; research priority setting etc.) The empirical data however showed that there was little involvement of study populations in decision-making within the H3Africa consortium, our case study. Whilst the different stakeholders acknowledged the importance of including study populations in governance processes, there were parallel concerns about its practicability. Despite these, the conceptual analysis and interview data confirms that there is need to first and foremost consider study populations as a key stakeholder group that should be involved in decision making, including decisions on secondary use of samples and data and in the development of biobank policies that will directly affect them. A new principle emerged from the empirical data. This was the principle of mutual respect. Following the reflective equilibrium approach, the framework was revised to include mutual respect as a core guiding principle. Conclusion Using the normative practice oriented bioethics approach, I have developed a novel, principlesbased governance framework for genomics research and biobanking in Africa. This framework, which was derived following a conceptual analysis of the governance theories, as well as the reflective equilibrium approach, seeks to address justice-related-(macro-level)- ELSI sin genomics research and biobanking in Africa. It and is grounded in theories of global health justice and the African moral theory of Ubuntu. Although the framework was developed to support the governance of genomics research and biobanking in Africa, its principles are likely to be applicable to other forms of global health research.
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    Open Access
    Ethical challenges in obtaining informed consent for the genomic study of rheumatic heart disease: a qualitative study
    (2016) Masiye, Francis; De Vries, Jantina; Mayosi, Bongani
    INTRODUCTION: Advances in genetic and genomic research have introduced new challenges in obtaining informed consent for research in low and middle-income settings. However, there are only few studies that have explored challenges in obtaining informed consent in genetic and genomic research in Africa and none in South Africa. To start filling this gap, we conducted an empirical study to investigate the efficacy of informed consent procedures for a genomic study on Rheumatic Heart Disease (RHDGen) at the University of Cape Town in South Africa. The main aim of the study was to understand the ethical challenges in obtaining informed consent in the RHDGen study. METHODS: We used a qualitative study methodology involving in-depth interviews and participant observations. Our research participants were RHDGen cases and controls as well as research staff involved in the recruitment of RHDGen research participants. In total, we conducted 32 in-depth interviews with RHDGen research participants, 2 in-depth interviews with research staff and 57 direct observations of the consent procedures of RHDGen research participants. The in-depth interviews were conducted in English, audio-recorded and transcribed verbatim. All the data were analysed using thematic content analysis. The study was conducted in 3 sites within Cape Town, South Africa, and these sites were the Groote Schuur Hospital in Observatory, the Vanguard Community Health Centre in Bonteheuwel and the Heideveld Community in the Cape Flats.
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    Expectations and Preferences of Parents and Adolescents Regarding Feedback of Individual Genetic Findings in an HIV-TB Genomic Research Project in Botswana
    (2022) Ralefala, Dimpho; De Vries, Jantina; Kasule, Mary; Matshaba, Mogomotsi
    Background: There has been tremendous progress in the use of genomics1 in biomedical research and medical care since the launch of the Human Genome Project in 1990. However, it has also introduced new ethical challenges regarding the feedback of findings generated in genomic sequencing. While some would argue in support of the return of individual findings generated from genomics research, participants' preferences regarding which findings should be fed back differs. Most literature discusses feedback of findings in high income countries and very few address this issue in lower and middle-income countries (LMICs). As a result, it remains unclear whether and how individual findings from genomic studies in Africa should be fed back, who should provide these results and when. Methods: In order to contribute to addressing this gap, an empirical study was conducted to explore expectations and preferences for feedback of individual genetic findings in an HIV-TB genomics research project in Botswana. A qualitative study methodology involving deliberative focus group discussions (dFGDs) and in-depth interviews (IDIs) was used. Participants for this study were adolescents involved in an HIV-TB genomics study being conducted at the Botswana-Baylor Children's Clinical Centre of Excellence (BBCCCE). Parents and caregivers of children enrolled in that same genomic study were also enrolled in this study. A total of 93 participants (44 adolescents and 49 parents and caregivers) were enrolled in 12 dFGDs (6 groups of adolescents and 6 groups of parents and caregivers). Each group of participants met twice within a week, resulting in a total of 24 dFGD meetings. Participants of the dFGDs and in-depth interviews were selected purposively. Additionally, indepth interviews were conducted with 12 dFGD participants (6 adolescents and 6 parents or caregivers). The dFGDs and IDIs were conducted in Setswana, audio-recorded, transcribed and translated into English. Data were imported into NVivo 12 and analysed using the framework approach for qualitative data analysis. Results: The study findings revealed that participants' desire to receive individual genetic results is underpinned by their cultural values, mainly solidarity and reciprocity. Participants viewed research participation as a mutual relationship and considered the return of research results to be one way of reciprocating their efforts. This seems to be underpinned by the principle of Ubuntu which advocates for solidarity and reciprocity within communities. Participants noted that when reciprocity obligations are respected, participants feel valued and expressed that not respecting reciprocity expectations could undermine participants' trust and participation in future studies. Almost all participants wanted to receive individual genetic results. While parents and caregivers wanted to receive individual genetic results regardless of their severity, preventability or actionability, adolescents were reluctant to receive results for genetic conditions that are severe and non-preventable, especially if they are also unactionable. Participants advanced different reasons for feedback of results including for awareness, improving lifestyle, accepting one's' situation, and preparing for the future. The findings also reveal the importance of taking into account participants' context, relations and empowerment when making decisions about whether and which results ought to be fed back. When asked about practical considerations for feedback of results, both adolescents and parents expressed that they would prefer to receive individual genetic results in person, with adolescents preferring researchers to provide feedback, while parents preferred feedback from doctors associated with the study. Adolescents and parents both expressed that feedback should be supported by counselling, but they differed on the timing of feedback. Most participants shared that they would like to be informed about the possibility of discovering individual genetic results during the consent process and that consent be obtained for feedback during the enrolment process. They further expressed that in cases where prior consent to feedback was not obtained, then participants should be re-contacted where lifesaving genetic information is discovered. Participants emphasized the need for researchers to ensure that participants' decisions regarding feedback of results are well-informed. Autonomy, transparency, and communication were identified as key values to uphold during the consent process. Conclusion: In conclusion, expectations of solidarity and reciprocity could translate into an obligation to feedback selected individual genetic results in African genomics research. Decisions on practicalities for feedback of results should take into account participants' context and considerations of participants' preferences. For example, in settings like BBCCCE it might be feasible for the study team to relay participants' results to treating doctors in the same centre, while also organising counselling services if necessary. However, in cases where a study is done in a public facility with limited resources, that could be difficult to implement. Consequently, researchers may have to take up the responsibility of feeding back individual results as well as providing genetic counselling in such settings. To make these decisions, researchers should engage with relevant stakeholders including policymakers and local Institutional Review Boards (IRBs) so as to make informed decisions regarding the feasibility and acceptability of their approach to feedback of results. Obtaining participants' consent for feedback of results is important to ensure that their rights and wellbeing are protected in research. This is critical in building trust relationships between participants and researchers. Lastly, although this study is focused in Botswana, these findings could also be generalised to similar contexts in Africa and provide an authoritative voice to H3Africa to be able to mandate projects with potential to generate individual genetic results to make provisions to feedback these results to study participants.
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    Exploring how a genetic attribution to disease relates to internalised stigma experiences of Xhosa people with schizophrenia and rheumatic heart disease in South Africa
    (2019) Matshabane, Olivia Precious; De Vries, Jantina; Campbell, Megan
    Advances in genomics research have brought forth a number of psychosocial concerns. In Africa, in particular, one of the concerns relates to the potential impact of genomics research on stigma experienced by specific population groups. Using a mixed-methods approach, this study sought to explore how genetic causal explanation relates to the internalised stigma experiences of a sample of South African Xhosa people with schizophrenia (n= 36) and rheumatic heart disease (n= 46). Additionally, a pilot study was conducted with another sample of schizophrenia (n= 65) and rheumatic heart disease (n= 55) patients to translate and adapt an internalised stigma of mental illness scale into isiXhosa. The aim of the study was operationalised into three research questions, namely; 1. What causal attribution models do Xhosa people with schizophrenia and rheumatic heart disease employ to explain their illness and to what extent do genetic explanations play a role in these causal models? 2. What are the internalised stigma experiences of Xhosa people with schizophrenia and rheumatic heart disease? 3. How do the genetic causal explanations of Xhosa people with schizophrenia and rheumatic heart relate to their internalised stigma experiences, if at all? Through focus-group discussions participants were introduced to non-genetic and genetic causal explanations and then asked a series of open-ended questions eliciting their perceptions of disease causation, genetic causation and the possible implications these perceptions may have on internalised stigma they may have experienced. Next, an internalised stigma of mental illness scale (ISMI) was translated through a mixed-methods translation approach into Xhosa and adapted for use in both disease groups. Insights from this translation were used to gain an understanding of how the Xhosa language supports particular descriptions and conceptualisations of stigma experiences. Psychometric results provided further insights into particularly relevant internalised stigma items for each disease group. Findings from the FGDs and translation process suggested that firstly Xhosa people with schizophrenia and those with rheumatic heart disease have a general understanding of genetics and genetic attribution to disease. Secondly, and not withstanding this knowledge, these participants hold a multitude of disease explanations. In consideration of the alternative causal explanations, and the factors these participants are exposed to, the genetic explanation did not appear to relate to their internalised stigma. While there was evidence of stigma in the two disease groups - schizophrenia patients reporting more stigma than the rheumatic heart disease sample - this stigma was not often related to a genetic attribution of disease. Findings suggest that the link between genetic attribution and stigma is complex. Due to the variable nature of the evidence derived from the study we cannot conclude that a genetic attribution is not related to stigma, however the findings provide clues as to why this is an unlikely implication for Xhosa people in these disease groups. This finding is different to empirical research which has been conducted in North American and European contexts. Although research in Western and European contexts suggests that attributing a disease to genetics may have an impact on disease-stigma, there have been minimal efforts to explore that assumption in the African context. This study, being one of the first to explore that assumption in an African population group, did not find consistent evidence to support it.
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    Investigating the views and experiences of Fetal Medicine Practitioners offering late termination of pregnancy in the Western Cape
    (2021) Francois, Sydney; De Vries, Jantina; Palk, Andrea
    Introduction: Fetal medicine practitioners (FMPs) are responsible for making decisions about the appropriateness of a late termination of pregnancy (LTOP) based on their assessment of the severity of the prenatal diagnosis while also taking into account the practical, legal and ethical aspects. This study aimed to investigate the views and experiences of FMPs involved in LTOP decision-making in the Western Cape and how these views may guide decisions to offer LTOP. Specifically, the research questions guiding this study aimed to investigate FMPs views on the Choice on Termination of Pregnancy Act (CTOPA), No. 92 of 1996, as well as their attitudes towards the provision and ethics of LTOP. Methodology: A total of six semi-structured, individual face-to-face interviews were conducted between February and March 2020 in the privacy of the participant's office. All interviews were audio-recorded and transcribed. Interpretive phenomenological analysis was used as a framework to analyse the data and transcripts were managed using NVivo 12 software. Results and Discussion: Participants believed that the CTOPA is based on the principle of gradualism and that while women have reproductive choice, TOP becomes progressively restricted as gestation advances to protect the fetus. However, they felt that the specified cut-offs in the CTOPA are arbitrary and open to interpretation and believed there is a need for further documentation to guide practitioners as to which conditions should be considered for LTOP. When making a decision to offer LTOP, participants considered various factors including fetal age, whether a feticide was required and the prognosis. Participants considered that conditions which qualified as severe were untreatable and would have a significant, long-term negative impact on the individual's functioning and quality of life. When considering acceptability of LTOP, participants felt that LTOP was justified to prevent suffering for both the future child and for the parents. However, participants did not believe that LTOP was justified to prevent all disability. Lastly, participants valued societal consensus when making morally demanding decisions and believed that decisions around LTOP needed to be made by multidisciplinary teams to ensure objectivity, as well as to share the moral burden.