African researchers' perceptions and expectations of the benefits of genomics research in Africa : a qualitative study

Introduction: Genomics research raises a number of ethical, legal and social issues (ELSI), one of which is the concept of benefit sharing. While benefits and benefit sharing are difficult to discuss because of questions on what needs to be shared, with whom and by whom, it cannot be pushed to the side-lines especially as it is a way of promoting justice in health research and of ensuring that research is of social value to study communities. In this study, we explored the perceptions and expectations of African genomics scientists on the benefits of genomics research to Africa. Method: This was a qualitative study and we adopted a grounded theory approach. I conducted 17 in-depth interviews with genomics researchers in Africa to explore their perceptions of benefits and benefit sharing in genomics research in Africa. Transcripts of interviews were imported into QSR-NVivo 10 for thematic analysis. A thematic analysis of informed consent documents used in 13 genomics studies in Africa was also done to explore how research benefits are documented. Results: Research collaboration, research capacity building and access to genomics medicine were perceived to be the main benefits of African genomics science (AGS). In terms of research collaboration, there were perceived fears of exploitation of African researchers and research participants, and the non-sustainability of AGS. To address the problem of exploitation, African researchers expressed the need for fairness in AGS through transparency and equity in research collaborations, enhancing research oversight, African ownership and leadership of AGS, community engagement and research capacity building. In terms of genomics medicine, African genomics researchers perceived that AGS would have an impact on healthcare in Africa in the area of diagnosis, pharmacogenomics and public health. However, there were concerns around access to genomics medicine by African populations, lack of capacity for genomics medicine in Africa and the need for AGS to focus on Africa's healthcare priorities. There was however limited awareness of the concept of benefit sharing among African genomics researchers though they perceived it is as an important concept for AGS. Interviewees suggested that benefit sharing could be in the form of research capacity building, feedback of study findings, science education, community projects and the sharing of profits

Developing a Principles-Based Framework to Link the Governance of Genomics Research and Biobanking in Africa to Global Health Justice

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

Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative

Abstract 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

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.

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

Responding to the COVID-19 Pandemic in Cameroon: A statement from the Cameroon Bioethics Initiative

The ongoing COVID-19 pandemic has caused devastating consequences across economies in the world, with substantial effects on lives and livelihoods. Cameroon has been one of the countries in sub-Saharan Africa with an increasing number of cases and fatalities from the disease. In an effort to support the government’s response to the epidemic, the Cameroon Bioethics Initiative (CAMBIN); a not-for-profit, non-governmental, non-political, non-discriminatory, multidisciplinary association issued a statement on COVID-19, primarily targeting the government and the general public. In this article, we situate the context within which the statement was issued and present the statement in its entirety

Knowledge and Challenges Associated With Hearing Impairment in Affected Individuals From Cameroon (Sub-Saharan Africa)

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

Perspectives of different stakeholders on data use and management in public health emergencies in sub-Saharan Africa: a meeting report

During public health emergencies (PHEs), data are collected and generated from a variety of activities and sources, including but not limited to national public health programs, research and community-based activities. It is critical that these data are rapidly shared in order to facilitate the public health response, epidemic preparedness, as well as research during and after the epidemic. Nonetheless, collecting and sharing data during PHEs can be challenging, especially where there are limited resources for public health and research-related activities. In a symposium that brought together different stakeholders that were involved in the 2013-2016 Ebola outbreaks in West Africa, meeting attendees shared their perspectives on the values and management of data during PHEs in sub-Saharan Africa. Key factors that could inform and facilitate data management during PHEs in sub-Saharan Africa were discussed, including using data to inform policy decisions and healthcare; a coordinated data collection and management scheme; identifying incentives for data sharing; and equitable data  governance mechanism that emphasise principles of reciprocity, transparency and accountability rather that trust between stakeholders or collaborators. Empirical studies are required to explore how these principles could inform best practices for data management and governance during PHE in sub-Saharan Africa.</ns3:p

Perspectives of different stakeholders on data use and management in public health emergencies in sub-Saharan Africa: a meeting report

During public health emergencies (PHEs), data are collected and generated from a variety of activities and sources, including but not limited to national public health programs, research and community-based activities. It is critical that these data are rapidly shared in order to facilitate the public health response, epidemic preparedness, as well as research during and after the epidemic. Nonetheless, collecting and sharing data during PHEs can be challenging, especially where there are limited resources for public health and research-related activities. In a symposium that brought together different stakeholders that were involved in the 2013-2016 Ebola outbreaks in West Africa, meeting attendees shared their perspectives on the values and management of data during PHEs in sub-Saharan Africa. Key factors that could inform and facilitate data management during PHEs in sub-Saharan Africa were discussed, including using data to inform policy decisions and healthcare; a coordinated data collection and management scheme; identifying incentives for data sharing; and equitable data  governance mechanism that emphasise principles of reciprocity, transparency and accountability rather that trust between stakeholders or collaborators. Empirical studies are required to explore how these principles could inform best practices for data management and governance during PHE in sub-Saharan Africa.</ns3:p

Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries

Background: The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when. Methods: In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Results: Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. Conclusions: There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers