Rules of engagement: perspectives on stakeholder engagement for genomic biobanking research in South Africa

Background: Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement (CE) for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective CE in genomic biobanking in Africa. Methods: To begin to address this vacuum, 17 in-depth face to face interviews were conducted with South African experts in genomic biobanking research and CE to provide insight into the process, benefits and challenges of CE in South Africa. Emerging themes were analysed using a contextualised thematic approach. Results: Several themes emerged concerning the conduct of CE in genomic biobanking research in Africa. Although the literature tends to focus on the local community in CE, respondents in this study described three different layers of stakeholder engagement: community level, peer level and high level. Community level engagement includes potential participants, community advisory boards (CAB) and field workers; peer level engagement includes researchers, biobankers and scientists, while high level engagement includes government officials, funders and policy makers. Although education of each stakeholder layer is important, education of the community layer can be most challenging, due to the complexity of the research and educational levels of stakeholders in this layer. Conclusion: CE is time-consuming and often requires an interdisciplinary research team approach. However careful planning of the engagement strategy, including an understanding of the differing layers of stakeholder engagement, and the specific educational needs at each layer, can help in the development of a relationship based on trust between the research team and various stakeholder groups. Since the community layer often comprises vulnerable populations in low and middle income countries (LMICs), co-development of innovative educational tools on genomic biobanking is essential. CE is clearly a component of a broader process best described as stakeholder engagement

Does the operations of the National Health Insurance Scheme (NHIS) in Ghana align with the goals of primary health care? Perspectives of key stakeholders in northern Ghana

In 2005, the World Health Assembly (WHA) of the World Health Organization (WHO) urged member states to aim at achieving affordable universal coverage and access to key promotive, preventive, curative, rehabilitative and palliative health interventions for all their citizens on the basis of equity and solidarity. Since then, some African countries, including Ghana, have taken steps to introduce national health insurance reforms as one of the key strategies towards achieving universal health coverage (UHC). The aim of this study was to get a better understanding of how Ghana's health insurance institutions interact with stakeholders and other health sector programmes in promoting primary health care (PHC). Specifically, the study identified the key areas of misalignment between the operations of the NHIS and that of PHC.; Using qualitative and survey methods, this study involved interviews with various stakeholders in six selected districts in the Upper East region of Ghana. The key stakeholders included the National Health Insurance Authority (NHIA), district coordinators of the National Health Insurance Schemes (NHIS), the Ghana Health Service (GHS) and District Health Management Teams (DHMTs) who supervise the district hospitals, health centers/clinics and the Community-based Health and Planning Services (CHPS) compounds as well as other public and private PHC providers. A stakeholders' workshop was organized to validate the preliminary results which provided a platform for stakeholders to deliberate on the key areas of misalignment especially, and to elicit additional information, ideas and responses, comments and recommendations from respondents for the achievement of the goals of UHC and PHC.; The key areas of misalignments identified during this pilot study included: delays in reimbursements of claims for services provided by health care providers, which serves as a disincentive for service providers to support the NHIS; inadequate coordination among stakeholders in PHC delivery; and inadequate funding for PHC, particularly on preventive and promotive services. Other areas are: the bypassing of PHC facilities due to lack of basic services at the PHC level such as laboratory services, as well as proximity to the district hospitals; and finally the lack of clear understanding of the national policy on PHC.; This study suggests that despite the progress that has been made since the establishment of the NHIS in Ghana, there are still huge gaps that need urgent attention to ensure that the goals of UHC and PHC are met. The key areas of misalignment identified in this study, particularly on the delays in reimbursements need to be taken seriously. It is also important for more dialogue between the NHIA and service providers to address key concerns in the implementation of the NHIS which is key to achieving UHC

Advancing non-communicable diseases research in Ghana: key stakeholders’ recommendations from a symposium

There has been a growing increase in the prevalence of non-communicable diseases (NCDs) globally with reports suggesting that the fastest increase in NCD deaths in the world will occur in sub-Saharan Africa (SSA) over the next 5 to 15 years. Despite the projected increase in NCD-related deaths, there is little coordinated research in many West African nations, including Ghana, to quantify and study this burden and to translate the research findings into policy and practice. To address these challenges, the Noguchi Memorial Institute for Medical Research and the Navrongo Health Research Centre, both in Ghana, with support from the Wits NCD Research Leadership Training Program organized a two-day symposium to discuss the advancement of NCD research in the West African sub-region. The aim was to propose the way forward for strengthening applied research that can inform the development of health policies and programs focused on NCDs. Participants were drawn from academia, research and health institutions, early career researchers and postdoctoral fellows. We present the key themes that emerged from the symposium and some strategies for advancing NCD research in West Africa. These include interdisciplinary collaboration between NCD researchers in the region, generation of accurate data on disease burden and strengthening stakeholder and public engagement on NCDs.Keywords: non-communicable diseases, health research, collaboration, public engagement, networkFunding: Funding for the symposium was provided by NIH Fogarty International Center–Grant numberD43TW008330, under the Wits Non-Communicable Disease Research Leadership Training Program

Informed consent in genomic research and biobanking: taking feedback of findings seriously.

Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and biobanking in Africa. This study was part of a multi-country qualitative case study conducted in three African countries: Ghana, Uganda and Zambia under the auspices of the Human Heredity and Health in Africa initiative (H3Africa). Our study suggests that while participants are willing to give consent for their samples and associated data to be used for future research purposes, they expect to receive feedback about the progress of the research and about the kinds of research being undertaken on their samples and data. These expectations need to be anticipated and discussed during the consent process which should be seen as part of an ongoing communication process throughout the research process

Promoting ethics and integrity in research and innovation for development in Africa : the role of Africa’s science granting councils : a discussion paper prepared for the Science Granting Councils Initiative (SGCI) master class of 2021

The paper advocates for Science Granting Councils (SGC) to enhance ethics and integrity activities as part of their responsibilities for supporting ethical conduct of research and innovation. SGCs should play a leading role in facilitating development of, or revision of research policies to ensure that ethics and integrity issues are addressed satisfactorily. The African science enterprise through SGCs, needs to adapt to growing concerns if it is to remain relevant. The paper provides an in- depth report of current and existing challenges within the purview of the Science Granting Councils, which was provided to SGCs from 15 participating African countries at the SGCI Masterclass event

Strengthening the role of African Science Granting Councils in promoting ethics and integrity in research and innovation

“Ethics and Integrity in Research and Innovation in Development” was the theme of the 2020 Science Granting Council’s (SGC) Masterclass. African SGCs need to enhance their activities and roles as part of their responsibilities in supporting ethical conduct of research and innovation. The African science enterprise through SGCs, needs to adapt to growing concerns if it is to remain relevant. SGCs should play a leading role in facilitating development of, or revision of research policies to ensure that ethics and integrity issues are addressed satisfactorily. This policy brief is a response to the growth in research being conducted in African countries.United Kingdom’s Foreign, Commonwealth and Development Office (FCDO)Swedish International Development Cooperation Agency (Sida)South African’s National Research Foundation (NRF)German Research Foundation (DFG

Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model [Commentary]

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned

The H3Africa policy framework: negotiating fairness in genomics

Human Heredity and Health in Africa (H3Africa) research seeks to promote fair collaboration between scientists in Africa and those from elsewhere. Here, we outline how concerns over inequality and exploitation led to a policy framework that places a firm focus on African leadership and capacity building as guiding principles for African genomics research

A scoping review of ethics review processes during public health emergencies in Africa

Background: The COVID-19 pandemic forced governments, multilateral public health organisations and research institutions to undertake research quickly to inform their responses to the pandemic. Most COVID-19-related studies required swift approval, creating ethical and practical challenges for regulatory authorities and researchers. In this paper, we examine the landscape of ethics review processes in Africa during public health emergencies (PHEs). Methods: We searched four electronic databases (Web of Science, PUBMED, MEDLINE Complete, and CINAHL) to identify articles describing ethics review processes during public health emergencies and/or pandemics. We selected and reviewed those articles that were focused on Africa. We charted the data from the retrieved articles including the authors and year of publication, title, country and disease(s) reference, broad areas of (ethical) consideration, paper type, and approach. Results: Of an initial 4536 records retrieved, we screened the titles and abstracts of 1491 articles, and identified 72 articles for full review. Nine articles were selected for inclusion. Of these nine articles, five referenced West African countries including Liberia, Guinea and Sierra Leone, and experiences linked to the Ebola virus disease. Two articles focused on South Africa and Kenya, while the other two articles discussed more general experiences and pitfalls of ethics review during PHEs in Africa more broadly. We found no articles published on ethics review processes in Africa before the 2014 Ebola outbreak, and only a few before the COVID-19 outbreak. Although guidelines on protocol review and approval processes for PHEs were more frequently discussed after the 2014 Ebola outbreak, these did not focus on Africa specifically. Conclusions: There is a gap in the literature about ethics review processes and preparedness within Africa during PHEs. This paper underscores the importance of these processes to inform practices that facilitate timely, context-relevant research that adequately recognises and reinforces human dignity within the quest to advance scientific knowledge about diseases. This is important to improve fast responses to PHEs, reduce mortality and morbidity, and enhance the quality of care before, during, and after pandemics

Policy makers, regulators and researchers’ perspectives on genomics research and the capacity of the National Health Research Act of 2013 to regulate genomics research in Zambia

Background: Health research in sub-Saharan Africa takes place against a lengthy history of exploitation and unfair collaboration. This has involved the export of samples and data from the continent for the benefit of institutions and researchers elsewhere. In this paper, we report the perspectives of people involved in conducting genomics research in Zambia and the capacity of the Health Research Act (HRA) of 2013 in regulating genomics research. Methods: We approached 14 purposively selected stakeholders involved in the development or implementation of the HRA in Zambia for in-depth interviews. These were members of research ethics committees, genomics researchers, Ministry of Health policy makers and institutional lawyers. Results: Participants reported that there are benefits in genomics research for Zambia such as diagnosing and treatment of diseases. Participants also expressed concerns, most of which were ethical in nature. Prominent concerns were on consent. Participants’ main concern was the possible misuse of samples in the future. These concerns resonated with the HRA, which prohibits the use of broad consent for the collection of samples and data for future unspecified research. The implications of this is that Zambians may not participate in any kind of health research for which the storage, sharing and re-use of data or samples is envisaged. The restrictive nature of HRA means that genomics research may be excluded from future health research collaborations, thus isolating the country from potentially beneficial health research. Some policy makers also worried the samples and data that comes from such research may be difficult to access by local scientists. Conclusion: In this article, we describe the views of Zambian policymakers on genomics research and the capacity of HRA in regulating genomics research. Our findings are relevant for the Zambian audience, and other African countries that are aiming to regulate health research, especially genomics research.</ns4:p