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Effectively addressing ethical issues in precision medicine research in Africa requires a holistic social contract that integrates biomedical knowledge with local cultural values and Indigenous knowledge systems. Drawing on African epistemologies such as ubuntu and ujamaa and on our collective experiences in genomics and big data research for sickle cell disease, hearing impairment, and fragile X syndrome and the project Public Understanding of Big Data in Genomics Medicine in Africa, we envision a transformative shift in health research data governance in Africa that could help create a sense of shared responsibility between all stakeholders in genomics and data-driven health research in Africa. This shift includes proposing a social contract for genomics and data science in health research that is grounded in African communitarianism such as solidarity, shared decision-making, and reciprocity. We make several recommendations for a social contract for genomics and data science in health, including the coproduction of genomics knowledge with study communities, power sharing between stakeholders, public education on the ethical and social implications of genetics and data science, benefit sharing, giving voice to data subjects through dynamic consent, and democratizing data access to allow wide access by all research stakeholders. Achieving this would require adopting participatory approaches to genomics and data governance., (© 2024 The Hastings Center.)

Competing Interests: We declare no competing interests. AW is supported by the National Institutes of Health (National Heart, Lung, and Blood Institute U24HL135600).

Background: Sickle cell disease (SCD) is a prevalent inherited blood disorder. Globally, approximately 515 000 babies are born with SCD annually, with 75% of these births occurring in Africa. Integrating newborn screening (NBS) for SCD into primary healthcare structures, such as immunisation programmes, holds significant promise, with dried blood spots (DBS)-point-of-care technologies (POCT) like HaemoTypeSC offering cost-effective screening solutions. However, scaling up DBS-POCT for NBS of SCD in Africa remains challenging., Objective: This study aims to explore individual, organisational and external factors that may influence the reliability, feasibility, acceptability, adoption and sustainability of using DBS-POCT with HaemoTypeSC for NBS of SCD at primary healthcare centres in African countries., Method: This qualitative study will be conducted in seven African countries that are part of the SickleInAfrica consortium sites. The study design is informed by the Consolidated Framework for Implementation Research (CFIR) and the Implementation Outcome Model. Participants will be mothers whose babies have been diagnosed with SCD, healthcare professionals and policy-makers. In-depth interviews and focus group discussions will be used for data collection. Data analysis will be through thematic analysis., Ethics and Dissemination: Research ethics approvals have been obtained from the seven countries. Written informed consent will be obtained from all participants. The study results will be disseminated in peer-reviewed scientific journals, scientific conferences, reports to national ministries of public health and webinars., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The increasing availability of large volumes of personal data from diverse sources such as electronic health records, research programmes, commercial genetic testing, national health surveys and wearable devices presents significant opportunities for advancing public health, disease surveillance, personalized medicine and scientific research and innovation. However, this potential is hampered by a lack of clarity related to the processing and sharing of personal health data, particularly across varying national regulatory frameworks. This often leaves researcher stakeholders uncertain about how to navigate issues around secondary data use, repurposing data for different research objectives and cross-border data sharing., Method: We analysed 37 data protection legislation across Africa to identify key principles and requirements for processing and sharing of personal health and genetic data in scientific research. On the basis of this analysis, we propose strategies that data science research initiatives in Africa can implement to ensure compliance with data protection laws while effectively reusing and sharing personal data for health research and scientific innovation., Results: In many African countries, health and genetic data are categorized as sensitive and subject to stricter protection. Key principles guiding the processing of personal data include confidentiality, non-discrimination, transparency, storage limitation, legitimacy, purpose specification, integrity, fairness, non-excessiveness, accountability and data minimality. The rights of data subjects include the right to be informed, the right of access, the right to rectification, the right to erasure/deletion of data, the right to restrict processing, the right to data portability and the right to seek compensation. Consent and adequacy assessments were the most common legal grounds for cross-border data transfers. However, considerable variation exists in legal requirements for data transfer across countries, potentially creating barriers to collaborative health research across Africa., Conclusions: We propose several strategies that data science research initiatives can adopt to align with data protection laws. These include developing a standardized module for safe data flows, using trusted data environments to minimize cross-border transfers, implementing dynamic consent mechanisms to comply with consent specificity and data subject rights and establishing codes of conduct to govern the secondary use of personal data for health research and innovation., (© 2024. The Author(s).)

Sickle cell disease (SCD) is a single gene blood disorder characterised by frequent episodes of pain, chronic anaemic, acute chest syndrome, severe disease complications and lifelong debilitating multi-system organ damage. Genetic testing and screening programs for SCD and the sickle cell trait (SCT) are valuable for early diagnosis and management of children living with SCD, and in the identification of carriers of SCT. People with SCT are for the most part asymptomatic and mainly identified as through genetic testing or when they have a child with SCD. This qualitative study explored perceptions towards genetic testing for SCD and SCT in Cameroon, Ghana, and Tanzania. The results show a general preference for newborn screening for SCD over prenatal and premarital/preconception testing, primarily due to its simpler decision-making process and lower risk for stigmatization. Premarital testing for SCT was perceived to be of low public health value, as couples are unlikely to alter their marriage plans despite being aware of their risk of having a child with SCD. Adolescents were identified as a more suitable population for SCT testing. In the case of prenatal testing, major concerns were centred on cultural, religious, and personal values on pregnancy termination. The study revealed a gender dimension to SCD/SCT testing. Participants mentionned that women bear a heightened burden of decision making in SCD/SCT testing, face a higher risk of rejection by potential in-laws/partners if the carriers of SCT, as well as the possibility of  divorce if they have a child with SCD. The study highlights the complex cultural, ethical, religious and social dynamics surrounding genetic testing for SCD and emphasises the need for public education on SCD and the necessity of incorporating genetic and psychosocial counselling into SCD/SCT testing programs., (© 2024. The Author(s).)

Somatic gene therapy will be one of the most exciting practices of genetic medicine in Africa and is primed to offer a "new life" for persons living with sickle cell disease (SCD). Recently, successful gene therapy trials for SCD in the USA have sparked a ray of hope within the SCD community in Africa. However, the high cost, estimated to exceed 1.5 million USD, continues to be a major concern for many stakeholders. While affordability is a key global health equity consideration, it is equally important to reflect on other ethical, legal and social issues (ELSIs) that may impact the responsible implementation of gene therapy for SCD in Africa. These include informed consent comprehension, risk of therapeutic misestimation and optimistic bias; priorities for SCD therapy trials; dearth of ethical and regulatory oversight for gene therapy in many African countries; identifying a favourable risk-benefit ratio; criteria for the selection of trial participants; decisional conflict in consent; standards of care; bounded justice; and genetic tourism. Given these ELSIs, we suggest that researchers, pharma, funders, global health agencies, ethics committees, science councils and SCD patient support/advocacy groups should work together to co-develop: (1) patient-centric governance for gene therapy in Africa, (2) public engagement and education materials, and (3) decision making toolkits for trial participants. It is also critical to establish harmonised ethical and regulatory frameworks for gene therapy in Africa, and for global health agencies to accelerate access to basic care for SCD in Africa, while simultaneously strengthening capacity for gene therapy., (© 2023. The Author(s).)

Purpose: Sickle cell disease (SCD) is an inherited blood disorder characterized by unpredictable episodes of acute pain and numerous health complications. Individuals with SCD often face stigma from the public, including perceptions that they are lazy or weak tending to exaggerate their pain crisis, which can profoundly impact their quality of life (QoL)., Methods: In a qualitative phenomenological study conducted in Cameroon, Ghana, and Tanzania, we explored stakeholders' perceptions of SCD-related stigma using three analytical frameworks: Bronfenbrenner's Ecological Systems Theory; The Health Stigma and Discriminatory Framework; and A Public Health Framework for Reducing Stigma., Results: The study reveals that SCD-related stigma is marked by prejudice, negative labelling and social discrimination, with derogatory terms such as sickler, ogbanje (one who comes and goes), sika besa (money will finish), ene mewu (I can die today, I can die tomorrow), vampire (one who consumes human blood), and Efiewura (landlord-of the hospital), commonly used to refer to individuals living with SCD. Drivers of stigma include frequent crises and hospitalizations, distinct physical features of individuals living with SCD, cultural misconceptions about SCD and its association with early mortality. Proposed strategies for mitigating stigma include public health education campaigns about SCD, integrating SCD into school curricula, healthcare worker training and community engagement., Conclusion: The results highlight the importance of challenging stigmatizing narratives on SCD and recognizing that stigmatization represents a social injustice that significantly diminishes the QoL of individuals living with SCD., (© 2023. The Author(s).)

Background: Genetic and genomic research is revolutionizing precision medicine; however, addressing ethical and cultural aspects is crucial to ensure ethical conduct and respect for community values and beliefs. This study explored the beliefs, perceptions and concerns of the Aari community in South Ethiopia regarding genetic concepts, hereditary diseases and ethical research practices related to sample collection, storage and sharing., Methods: In-depth interviews and focus group discussions were conducted with community elders, health officials, tuberculosis patients and apparently healthy individuals. Data were thematically analysed using MAXQDA software., Results: Participants identified diseases such as podoconiosis, leprosy, goitre and epilepsy as hereditary and perceived some as 'curses' due to generational impact and social stigma. Disease susceptibility was attributed to divine intervention or factors such as malnutrition and sanitation. Although hereditary diseases were considered unavoidable, in some cases environmental factors were acknowledged. Participants shared personal examples to demonstrate inheritance concepts. Blood held cultural significance, and concerns about its potential misuse resulted in scepticism towards giving samples., Conclusions: This study emphasizes the significance of comprehending local beliefs and perceptions and stresses the need to establish effective communication, build trust and address underlying causes of hesitancy to improve recruitment and ensure ethical conduct., (© The Author(s) 2023. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)

Phylogenetic analyses of HIV are an increasingly accurate method of clarifying population-level patterns of transmission and linking individuals or groups with transmission events. Viral genetic data may be used by public health agencies to guide policy interventions focused on clusters of transmission or segments of the population in which transmission is concentrated. Analyses of HIV phylogenetics in high-income countries have often found that clusters of transmission play a significant role in HIV epidemics. In sub-Saharan Africa, HIV phylogenetic analyses to date suggest that clusters of transmission play a relatively minor role in local epidemics. Such analyses could nevertheless be used to guide priority setting and HIV public health programme design in Africa for sub-populations in which transmission events are more concentrated. Phylogenetic analysis raises ethical issues, in part due to the range of potential benefits and potential harms (ie, risks). Potential benefits include (1) improving knowledge of transmission patterns, (2) informing the design of focused public health interventions for subpopulations in which transmission is concentrated, (3) identifying and responding to clusters of transmission, (4) reducing stigma (in some cases) and (5) informing estimates of the (cost-)effectiveness of HIV treatment programmes. Potential harms include (1) privacy infringements, (2) increasing stigma (in some cases), (3) reducing trust in public health programmes, and (4) increased prosecution of legal cases where HIV transmission, homosexuality or sex work is criminalised. This paper provides analysis of relevant issues with a focus on sub-Saharan Africa in order to inform consultations regarding ethical best practice for HIV phylogenetics., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

We previously proposed a structure for recording consent-based data use 'categories' and 'requirements' - Consent Codes - with a view to supporting maximum use and integration of genomic research datasets, and reducing uncertainty about permissible re-use of shared data. Here we discuss clarifications and subsequent updates to the Consent Codes (v4) based on new areas of application (e.g., the neurosciences, biobanking, H3Africa), policy developments (e.g., return of research results), and further practical considerations, including developments in automated approaches to consent management., (© 2022. The Author(s).)

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries., (© 2022. The Author(s).)

To embrace the prospects of accurately diagnosing thousands of monogenic conditions, predicting disease risks for complex traits or diseases, tailoring treatment to individuals' pharmacogenetic profiles, and potentially curing some diseases, research into African genomic variation is a scientific imperative. African genomes harbor millions of uncaptured variants accumulated over 300,000 years of modern humans' evolutionary history, with successive waves of admixture, migration, and natural selection combining with extensive ecological diversity to create a broad and exceptional genomic complexity. Harnessing African genomic complexity, therefore, will require sustained commitment and equitable collaboration from the scientific community and funding agencies. African governments must support academic public research and industrial partnerships that build the necessary genetic medicine workforce, utilize the emerging genomic big data to develop expertise in computer science and bioinformatics, and evolve national and globalgovernance frameworks that recognize the ethical implications of data-driven genomic research and empower its application in African social, cultural, economic, and religious contexts.

The post-genomics era promises a revolution characterized by precision medicine and the integration of genomics into almost every area of biomedical research. At the same time, there are concerns that if care is not taken, the genomics revolution may widen global inequities in science and health. In Africa, these concerns are primarily linked to the underrepresentation of African populations in genomics research, limited genomics research capacity in Africa and associated macro-level justice issues such as benefit sharing, inequitable international research collaborations, and the contribution of genomics to the health and research priorities of Africa. Addressing these concerns requires an in-depth reflection on how the ideals of global justice and equity may be advanced in genomics research. To contribute to the limited but growing scholarship on global genomics equity, especially in the African context, we performed a conceptual analysis of three accounts of justice and governance namely, Ubuntu, shared health governance and global governance of health, with the aim of identifying principles that could inform genomics governance in Africa. We used a convergence approach in the conceptual analysis, resulting in the identification of nine principles namely: solidarity, furthering the ideals of health justice, reciprocity, shared decision-making, shared resources, shared responsibility, mutual trust, transparency, and mutual collective accountability. Examples of how the principles may be applied are provided. We recommend that these principles should form the foundation of any mechanism that seeks to systematically advance justice, fairness and equity in genomics research in Africa and more broadly, global health and science equity., (© 2022 John Wiley & Sons Ltd.)

Among the myriad causes of intellectual disability (ID), Fragile X Syndrome (FXS) is the leading genetic cause. Yet, little is known of how people affected by this condition make sense of it. The present study aimed to investigate the explanatory models for the causes of FXS in an extended family mainly affected by this condition and members of the village from which they originated in Cameroon. Using an ethnographic approach, 92 participants were interviewed (59 females and 33 males) through 10 focus group discussions and 23 in-depth interviews between April 2018 and February 2020. Data analysis revealed four explanatory models regarding the etiologies of FXS in the community. Firstly, the curse model described a curse from the chief because of the belief that his wives did not mourn his intellectually disabled servant. Secondly, the spiritual model relates FXS to a punishment from God. Thirdly, the socioeconomic model attributes FXS to events in the prenatal and perinatal periods. Finally, the genetic model describes the pattern of inheritance of the disease in the family. This paper helps to understand the explanatory disease models that exist for FXS in rural Cameroon and could inform genetic counseling practices, community genetic education, and policymakers when drafting protocols for public engagement activities., (© 2021 The Authors. Journal of Genetic Counseling published by Wiley Periodicals LLC on behalf of National Society of Genetic Counselors.)

Background: This study aimed to gain an understanding of the challenges faced by people with hearing impairment (HI) in Cameroon, their understanding of the causes of HI, and how challenges could be remedied to improve the quality of life of persons with HI. Methods: Semi-structured one-on-one in-depth interviews and observation of participant behaviour when answering questions were used to collect data from 10 HI professionals (healthcare workers and educationists), and 10 persons affected by HI (including caregivers). Results: The results show that the different groups associate the causes of HI to genetics, environmental factors, and a spiritual curse. There were reported cases of stigma and discrimination of persons with HI, with people sometimes referring to HI as an "intellectual disorder." Interviewees also highlighted the difficulty persons with HI have in accessing education and healthcare services and suggested the need for the government and health researchers to develop strategies for the prevention and early diagnosis of HI. These strategies include (1) the awareness of the general population regarding HI, (2) the development of facilities for the proper management and new-born screening of HI, and (3) the implementation of a premarital screening to reduce the burden of HI of genetic origin. Conclusions: This study confirms the difficult social interaction and access to proper management faced by persons with HI in Cameroon and further highlights the need to educate populations on the causes of HI for a better acceptance of individuals with HI in the Cameroonian society., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Wonkam-Tingang, Kengne Kamga, Adadey, Nguefack, De Kock, Munung and Wonkam.)

International collaborations have become the standard model for global health research and often include researchers and institutions from high income countries (HICs) and low- and middle-income countries (LMICs). While such collaborations are important for generating new knowledge that will help address global health inequities, there is evidence to suggest that current forms of collaboration may reproduce unequal power relations. Therefore, we conducted a qualitative study with scientists, researchers and those involved in research management, working in international health collaborations. Interviews were conducted between October 2019 and March 2020. We conducted 13 interviews with 15 participants. From our findings, we derive three major themes. First, our results reflect characteristics of equitable, collaborative research relationships. Here we find both relational features, specifically trust and belonging, and structural features, including clear contractual agreements, capacity building, inclusive divisions of labour, and the involvement of local communities. Second, we discuss obstacles to develop equitable collaborations. These include exclusionary labour practices, donor-driven research agendas, overall research culture, lack of accountability and finally, the inadequate financing of indirect costs for LMIC institutions. Third, we discuss the responsibilities for promoting science equity of funders, LMIC researchers, LMIC institutions, and LMIC governments. While other empirical studies have suggested similar features of equity, our findings extend these features to include local communities as collaborators in research projects and not only as beneficiaries. We also suggest the importance of funders paying for indirect costs, without which the capacity of LMIC institutions will continually erode. And finally, our study shows the responsibilities of LMIC actors in developing equitable collaborations, which have largely been absent from the literature., Competing Interests: N/A

There is growing interest for a communitarian approach to the governance of genomics, and for such governance to be grounded in principles of justice, equity and solidarity. However, there is a near absence of conceptual studies on how communitarian-based principles, or values, may inform, support or guide the governance of genomics research. Given that solidarity is a key principle in Ubuntu, an African communitarian ethic and theory of justice, there is emerging interest about the extent to which Ubuntu could offer guidance for the governance of genomics research in Africa. To this effect, we undertook a conceptual analysis of Ubuntu with the goal of identifying principles that could inform equity-oriented governance of genomics research. Solidarity, reciprocity, open sharing, accountability, mutual trust, deliberative decision-making and inclusivity were identified as core principles that speak directly to the different macro-level ethical issues in genomics research in Africa such as: the exploitation of study populations and African researchers, equitable access and use of genomics data, benefit sharing, the possibility of genomics to widen global health inequities and the fair distribution of resources such as intellectual property and patents. We use the identified the principles to develop ethical guidance for genomics governance in Africa., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V.)

COVID-19, caused by a novel coronavirus named SARS-CoV-2, was identified in December 2019, in Wuhan, China. It was first confirmed in sub-Saharan Africa in Nigeria on 27 February 2020 and has since spread quickly to all sub-Saharan African countries, causing more than 111,309 confirmed cases and 2,498 deaths as of 03 June 2020. The lessons learned during the recent Ebola virus disease (EVD) outbreaks in some sub-Saharan African countries were expected to shape and influence the region's responses to COVID-19 pandemic. However, some of the challenges associated with the management of the EVD outbreaks persist and create obstacles for the effective management of the COVID-19 pandemic. This article describes the commonalities between the EVD epidemics and COVID-19 pandemic, with a view to draw on lessons learned to effectively tackle the ongoing pandemic. Key successes, failures and lessons learned from previous EVD outbreaks are discussed. Recommendations on how these lessons can be translated to strengthen the COVID-19 response in sub-Saharan Africa are provided., (© 2020 John Wiley & Sons Ltd.)

Background: Fragile X Syndrome (FXS) is a neurogenetic condition that significantly impacts the lives of affected individuals and their families due to its association with intellectual disability (ID) and stigma., Method: In this paper, we present the findings of an ethnographic study in the community of a patient who received a genetic diagnosis for FXS in Cameroon. This study builds on data from 28 participants of a royal family and 58 from the community who participated in 20 in-depth interviews and nine focus group discussions., Results: We identified two types of stigma in this community: public stigma directed towards the royal family and associative stigma experienced by royal family members. We outline the stereotyping labels used for the family and its children with Fragile X Syndrome and describe the stigma-power dynamic between the community members and the royal family. First, most villagers use less stigmatizing terms to addressing FXS children from the chieftaincy because of their position in society. Secondly, due to their social position, the royal family uses their status to negotiate marriages with community members. From these observations, we can suggest that the primary role of stigma in this community is to keep people away from FXS and keep them down through domination and exploitation., Conclusion: We advocate that other researchers examine if the same pattern exists in other inheritable forms of ID and conduct more qualitative research on FXS in Africa., (© 2021 The Authors. Molecular Genetics & Genomic Medicine published by Wiley Periodicals LLC.)

Developments in genomics in the last decade has improved our understanding of the role of genetics in health and disease. One area where the impact of genomics is very noticeable is in oncology, specifically in terms of diagnosis and elucidating genetic predisposition to rare and common cancers. Sub-Saharan Africa (SSA) stands to benefit from cancer genomics, given recent spikes in the incidence of various types of cancers in the region. This mini review presents, from a health and science equity perspective, how genomics could shape cancer research and clinical care in SSA. We highlight some pan-African genomics and cancer initiatives that are facilitating cancer genomics research in SSA. We conclude with recommendations on how the ideals of equity may be advanced in cancer genomics initiatives in SSA., (Copyright © 2021. Published by Elsevier Ltd.)

Background: Whilst global health research often involves international collaborations, achieving or promoting equity within collaborations remains a key challenge, despite established conceptual approaches and the development of frameworks and guidelines to promote equity. There have also been several empirical studies documenting researchers' experiences of inequity and views on what is required to advance equity in global health collaborations. While these empirical studies provide critical insights, there has been no attempt to systematically synthetize what constitutes equity and how it can be achieved. To address this gap, we conducted a scoping review of qualitative studies, opinion and editorial pieces about what equity is and how it can be promoted in international collaborations., Methods: We conducted a scoping review to explore domains of equity in international health collaborations. This review included qualitative studies and opinion pieces or editorial pieces on equity in international health collaborations. We mapped the data and identified common themes using a thematic analysis approach., Results: This initial search retrieved a total of 7611 papers after removing duplicates. A total of 11 papers were included in this review, 10 empirical studies and 1 editorial piece. We conducted our search between October - November 2019. We identified 10 key domains which are important for promoting equity in international collaborations: funding; capacity building; authorship; sample ownership and export; trust; research agreement; acknowledging inequality; recognition and communication., Discussion: Our findings suggest that for international collaborations to be considered more equitable, it must at least consider the 10 domains we highlighted. The 10 domains map onto five key aspects of social justice theory, namely avoiding unequal power relations like subordination, group recognition and affirmation, promoting the well-being of all, inclusion in decision-making and ensuring self-development.

Benefit sharing is an ethical issue that underscores the need to find a balance between access to genetic resources and the provision of fair benefits in exchange for access. The Human Genome Organisation (HUGO) is one of the few initiatives to have engaged with the topic of benefit sharing in human genomics. However, there is a lack of clarity on what benefit sharing entails in human genomics research and how it could be implemented in practice. This paper reports on a qualitative study that explored the views and expectations of benefit sharing by a group of genomics researchers in sub-Saharan Africa. Overall, while there was little awareness of benefit sharing among the researchers, there was support for benefit sharing in human genetics, and this was based on principles of fairness, solidarity, and reciprocity. This in-depth explorative study demonstrates the need for genomics research consortia in Africa to have open discussions on benefit sharing and to develop ethics frameworks for benefit sharing in population genomics studies in Africa. HUGO's statement on benefit sharing and the Nagoya Protocol could provide guidance., (© 2020 by The Hastings Center. All rights reserved.)

Competing Interests: Competing interests: None declared.

Development of biobanks in Africa raises ethical questions related to particular features of African cancer research contexts, such as underresourced health care and research infrastructures and low-average research literacy. This article describes ethical challenges of informed consent, benefit sharing, and stigmatization and proposes navigating these challenges by developing a comprehensive governance framework to ensure African leadership in biobanking research programs in Africa., (© 2020 American Medical Association. All Rights Reserved.)

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.

Sickle cell disease (SCD) is one of the most prevalent genetic conditions in sub-Saharan Africa. It is a chronic, lifelong disease often characterized by severe pain. However, SCD has received little investment terms of health research, though there is currently a growing pool of SCD data from health and research facilities in different countries. To facilitate research on SCD in Africa, the SickleInAfrica consortium has established a SickleInAfrica registry. The registry will store a systematic collection of longitudinal data from persons with SCD across sub-Saharan Africa, and currently, participants are being enrolled in Ghana, Nigeria, and Tanzania. In establishing this registry, the SickleInAfrica consortium decided to actively identify and anticipate possible ethical issues that may arise in the development and management of the registry. This was motivated, in part, by the near absence of well documented ethical issues for registry research in Africa, more-so for registries enrolling participants across multiple countries and for a genetic condition. The consortium aims to establish standards for the equitable use of data stored in the registry. This paper presents a comprehensive report on the ethical considerations that came up in setting up a genetic disease registry across multiple African countries and how they were addressed by the SickleInAfrica consortium. Major issues included: active involvement of patients in the initiation and management of the registry; questions of assent and re-consent; the importance of ensuring that fears of exploitation are not replicated in African-African research collaborations; and the importance of public engagement in the management of registries. Drawing on this experience, SickleInAfrica plans to set up an ethics helpdesk for genetic disease registries and research in Africa., (Copyright © 2019 Munung, Nembaware, de Vries, Bukini, Tluway, Treadwell, Sangeda, Mazandu, Jonas, Paintsil, Nnodu, Balandya, Makani, Wonkam.)

Genomic research and biobanking are expanding globally, with a promise to fast-track the research needed to improve approaches to disease treatment and prevention through scientific collaborations such as the Human Heredity and Health in Africa (H3Africa) initiative. Integral to this type of research is the availability of samples and data for research. The need for broad access brings along a host of ethical concerns, including those related to privacy and confidentiality, as well as fairness and equity in access and capacity to utilise these samples between scientists from the high income and low income countries. Addressing these concerns while promoting genomic research, especially in Africa, requires the implementation of a sound governance framework. In this paper, we describe the contents of a Framework for Best Practice for Genomics Research and biobanking in Africa that was developed, under the auspices of the H3Africa initiative. This framework is broad enough to be used and adapted by African countries to facilitate the development of country-specific guidelines and to help improve the conduct and governance of genomics research., Competing Interests: No competing interests were disclosed., (Copyright: © 2018 Yakubu A et al.)

Although the world has experienced remarkable progress in health care since the last half of the 20th century, global health inequalities still persist. In some poor countries life expectancy is between 37-40 years lower than in rich countries; furthermore, maternal and infant mortality is high and there is lack of access to basic preventive and life-saving medicines, as well a high prevalence of neglected diseases, HIV/AIDS, tuberculosis, and malaria. Moreover, globalization has made the world more connected than before such that health challenges today are no longer limited within national or regional boundaries, making all persons equally vulnerable. Because of this, diseases in the most affluent countries are closely connected with diseases in the poorest countries. In this paper, we argue that, because of global health inequalities, in a situation of equal vulnerability, there is need for global solidarity not only as a means of reducing health inequalities, but also as a way of putting up a united force against global health challenges. We argue for an African approach to solidarity in which the humanity of a person is not determined by his/her being human or rational capacity, but by his/her capacity to live a virtuous life. According to this view of solidarity, because no one is self-sufficient, no individual can survive alone. If we are to collectively flourish in a world where no individual, nation or region has all the health resources or protection needed for survival, we must engage in solidarity where we remain compassionate and available to one another at all times., (© 2017 John Wiley & Sons Ltd.)

Africa may be heading for an era of genomics medicine. There are also expectations that genomics may play a role in reducing global health inequities. However, the near lack of genomics studies on African populations has led to concerns that genomics may widen, rather than close, the global health inequity gap. To prevent a possible genomics divide, the genomics 'revolution' has been extended to Africa. This is motivated, in part, by Africa's rich genetic diversity and high disease burden. What remains unclear, however, are the prospects of using genomics technology for healthcare in Africa. In this qualitative study, we explored the views of 17 genomics researchers in Africa on the prospects and challenges of genomics medicine in Africa. Interviewees were researchers in Africa who were involved in genomics research projects in Africa. Analysis of in-depth interviews suggest that genomics medicine may have an impact on disease surveillance, diagnosis, treatment and prevention. However, Africa's capacity for genomics medicine, current research priorities in genomics and the translation of research findings will be key defining factors impacting on the ability of genomics medicine to improve healthcare in Africa.

Introduction and Method: Africa is currently host to a number of international genomics research and biobanking consortia, each with a mandate to advance genomics research and biobanking in Africa. Whilst most of these consortia promise to transform the way international health research is done in Africa, few have articulated exactly how they propose to go about this. In this paper, we report on a qualitative interviewing study in which we involved 17 genomics researchers in Africa. We describe their perceptions and expectations of international genomics research and biobanking initiatives in Africa., Results: All interviewees were of the view that externally funded genomics research and biobanking initiatives in Africa, have played a critical role in building capacity for genomics research and biobanking in Africa and in providing an opportunity for researchers in Africa to collaborate and network with other researchers. Whilst the opportunity to collaborate was seen as a benefit, some interviewees stressed the importance of recognizing that these collaborations carry mutual benefits for all partners, including their collaborators in HICs. They also voiced two major concerns of being part of these collaborative initiatives: the possibility of exploitation of African researchers and the non-sustainability of research capacity building efforts. As a way of minimising exploitation, researchers in Africa recommended that genuine efforts be made to create transparent and equitable international health research partnerships. They suggested that this could be achieved through,: having rules of engagement, enabling African researchers to contribute to the design and conduct of international health projects in Africa, and mutual and respectful exchange of experience and capacity between research collaborators. These were identified as hallmarks to equitable international health research collaborations in Africa., Conclusion: Genomics research and biobanking initiatives in Africa such as H3Africa have gone some way in defining aspects of fair and equitable research collaborations in Africa. However, they will need to strive at achieving equitable health research collaborations if they truly aim at setting a gold standard for how international health research should be conducted in Africa.

Background: Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee (REC) for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures of operation. Guidelines for elaborating standard operating procedures (SOPs) for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments., Methods: In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization (WHO)'s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee (ERCC) of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO's guidelines and to the other SOPs., Results: Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed (65 and 102 pages), while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols., Conclusions: We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing.

Background: The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium., Methods: A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results., Results: Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results., Conclusion: H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Scientific publication is commonly used to communicate research findings and in most academic/research settings, to evaluate the potential of a researcher and for recruitment and promotion. It has also been said that researchers have the duty to make public, the findings of their research. As a result, researchers are encouraged to share their research findings with the scientific world through peer review publications. In this study, we looked at the characteristics and publication rate of theses that documented studies on human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome in Cameroon., Materials and Methods: TO CHECK IF A THESIS RESULTED IN A PUBLICATION, WE SEARCHED: A database of publications on HIV in Cameroon, African Journals Online, PubMed and Google scholar. For each publication we recorded if the student was an author, the position of the student in the author listing, the journal and where the journal was indexed. We also looked at the impact factor of the journals., Results: One hundred and thirty theses/dissertations were included in the study, 74.6% (97/130) were written as part of a medical degree (MD), 23.8% (31/130) a postgraduate (PG) degree and 1.5% (2/130) for a Doctorate/PhD. On a whole, 13.9% (18/130) of the theses resulted in at least one publication in a scientific journal with a total of 22 journal articles, giving a mean publication rate of 0.17 article/thesis, 86.4% (11/22) were indexed on PubMed, 9.1% (2/22) on African Journals Online and 4.6% (1/22) on Google scholar. One PG thesis led to two book chapters. The student was the first author in 22.7% (5/22) of the articles and not an author in 9.1% (2/22) of the articles. Student supervisor was an author in all the articles., Conclusion: This study reveals that most students in Cameroon failed to transform their theses/dissertations to scientific publications. This indicates an urgent need to sensitize students on the importance of presenting their research findings in scientific meetings and peer reviewed journals. There is also a great necessity to build capacity in scientific writing among university students in Cameroon.

Background: Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics., Method: Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed., Results: Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors' degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned., Conclusions: Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance.

We assessed the extent of research ethics approval and informed consent reporting in publications emanating from Cameroon and indexed in PubMed from 2005-2009. In our review of 219 full-length articles, we found that 57.53% reported ethics approval, 70.78% informed consent, and 50.68% both ethics approval and informed consent. Reporting these procedures was more common in randomized clinical trials than in other study designs. Also, 59.52% of the articles on vulnerable populations documented ethics approval and 76.19% documented informed consent. This study also identified some structures for ethics review and recommends some next steps for research on the quality of ethics review in Cameroon.

Cameroon is a Central African country lying at latitude 6°N and longitude 12°E. The country has a surface area of circa 475,442 square kilometers, and is bordered by several other African countries: Nigeria, Chad, the Central African Republic, the Republic of Congo, Equatorial Guinea, and Gabon. With a population of nearly 20 million inhabitants, Cameroon is a very diverse country, geographically, culturally, and linguistically.