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 (...) class='Hi'>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. (shrink)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate (...) within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees. The urgent need for continued capacity development in Africa has necessitated research initiatives to identify existing capacity. This discussion paper describes the mapping of RECs in (...) class='Hi'>Africa through MARC project, second phase and discusses the findings. MARC provides a platform and tool on COHRED's Health Research HRWeb, which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 293-302.

This book is a collection of fictionalized case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of political and economic inequality are particularly evident. It is a training tool to fill the gap between research ethics guidelines and their implementation "on the ground." The cases focus on "relational" ethics: ethical actions and ideas that continuously emerge through relations with others, rather than being determined by (...) bioethics regulation. They are based on stories and experiences collected by a group of social anthropologists who have worked with leading transnational medical research organizations across Africa in the past decade. Accompanied by guidelines, discussion questions and selected further readings, the book provides a flexible resource for training and self-study for people engaged in health research with, universities, international collaborative sites and NGOs and for everyone interested in the realities of global health research today.". (shrink)

It is nearly two decades now since the publication of Godfrey Tangwa's article, ‘Bioethics: African Perspective’, without a critical review. His article is important because sequel to its publication in Bioethics, the idea of ‘African bioethics’ started gaining some attention in the international bioethics literature. This paper breaks this relative silence by critically examining Tangwa's claim on the existence of African bioethics. Employing conceptual and critical methods, this paper argues that Tangwa's account of African bioethics has some conceptual, methodic and (...) substantive difficulties, which altogether do not justify the idea of African bioethics, at least for now. Contra Tangwa, this article establishes that while African bioethics remains a future possibility, it is more cogent that current efforts in the name of ‘African bioethics’ be primarily re-intensified towards ‘Healthcare ethics in Africa’. (shrink)

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. (shrink)

BackgroundInternational codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for (...) the relevance and cogency of an ethical code in occupational health for an African context through an iterative consultative process.DiscussionFirstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace.SummaryA stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region. (shrink)

Background Clinical Ethics Committees are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services on the continent. Methods A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and (...) bioethicists in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics. All participants were familiar with Research Ethics Committees, and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. (shrink)

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the generally lower (...) protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South. (shrink)

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts (...) of its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

This chapter provides an overview of public health in AfricaAfrica in four main sections. One section explores challenges and promises to public health posed by the size and diversity of Africa. The second section explores the challenges and promises of Africa’s infrastructure. The third section explores existing crises like the HIVHIV/AIDSAIDS pandemic and emerging crises like food insecurity. However, in the fourth section, I suggest that Africa’s biggest public health challenges are rooted in stigma (...) and fear. (shrink)

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. (shrink)

Those whom the gods wish to destroy, they first make mad, says a Nigerian proverb. These words of wisdom re-echo in traditional approaches to mental health ethics in sub-Saharan Africa. Among many cultures in Nigeria, it is customary to subject persons with mental health illness, especially those who present with violent behavior, to physical restraint and beatings. The belief is that such subjugation could restore mental health in the early stages of madness. Physical restraint and (...) beatings only form a part of the healing process, as it also has communitarian cum spiritual aspects. The healing process is carried out by family members or community, who share in the life of the mentally ill person. Their... (shrink)

The Johns Hopkins‐Fogarty African Bioethics Training Program (FABTP) has offered a fully‐funded, one‐year, non‐degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub‐Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts (...) of its trainees.Our data show that since 2001, the 28 former FABTP trainees have authored or co‐authored 105 new bioethics‐related publications; were awarded 33 bioethics‐related grants; played key roles on 78 bioethics‐related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post‐training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs. (shrink)

Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe (...) the proposal by Kenya’s national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity. (shrink)

South Africa currently has a pluralistic health care system with separate public and private sectors. It is, however, moving towards a socialised model with the introduction of National Health Insurance. The South African legislative environment has changed recently with the promulgation of the Consumer Protection Act and proposed amendments to the National Health Act. Patients can now be viewed as consumers from a legal perspective. This has various implications for health care systems, health care (...) providers and the doctor-patient relationship. (shrink)

Bioethics, Volume 36, Issue 4, Page 411-422, May 2022.

ABSTRACT Previous research has consistently highlighted the importance of stakeholder engagement in identifying and developing solutions to ethical challenges in genomic research, especially in Africa where such research is relatively new. In this paper, we examine what constitutes good ethical practice in research, from the perspectives of genomic research participants in Uganda. Our study was part of a multi-site qualitative study exploring these issues in Uganda, Ghana and Zambia. We purposively sampled various stakeholders including genomic research participants, researchers, research (...) ethics committee members, policy makers and community members. This paper presents the findings from in-depth interviews with 27 people with diabetes who had participated in a diabetes genomic study. Data were collected using semi-structured interviews. Manual thematic content analysis was conducted using a framework approach. Findings indicate three key requirements that research participants see as vital for genomic research to be more responsive to research participants’ needs and contextual realities: (1) de-emphasising the role of experts and institutions in the consenting process, (2) clarity about the timing and nature of feedback both of findings relevant to the health of individuals and about the broad progress of the study, and (3) more effective support for research participants during and after the study. (shrink)

ABSTRACT Previous research has consistently highlighted the importance of stakeholder engagement in identifying and developing solutions to ethical challenges in genomic research, especially in Africa where such research is relatively new. In this paper, we examine what constitutes good ethical practice in research, from the perspectives of genomic research participants in Uganda. Our study was part of a multi-site qualitative study exploring these issues in Uganda, Ghana and Zambia. We purposively sampled various stakeholders including genomic research participants, researchers, research (...) ethics committee members, policy makers and community members. This paper presents the findings from in-depth interviews with 27 people with diabetes who had participated in a diabetes genomic study. Data were collected using semi-structured interviews. Manual thematic content analysis was conducted using a framework approach. Findings indicate three key requirements that research participants see as vital for genomic research to be more responsive to research participants’ needs and contextual realities: (1) de-emphasising the role of experts and institutions in the consenting process, (2) clarity about the timing and nature of feedback both of findings relevant to the health of individuals and about the broad progress of the study, and (3) more effective support for research participants during and after the study. (shrink)

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is (...) thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed.This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. (shrink)

Public health decisions made by the state involve considerable disagreements on the course of actions, uncertainties, and compromises that arise from moral tensions between the demands of civil liberties and the goals of public health. With such complex decisions, it can be extremely difficult to arrive at and justify the best option. In this article, we propose an ethical decision-making framework based on the philosophy of Ubuntu and argue that in sub-Saharan African settings, this approach provides attractive alternative (...) conventions of moral decision-making and a useful language for understanding moral reasoning and ethics. Through its emphasis on humanity, compassion, and social responsibility, Ubuntu (“I am because we are”) has the potential to facilitate solutions to and avert conflicts between individual rights and public health. The use of Ubuntu shifts the moral reasoning and ethics of decision-making from a field of philosophy shaped by the global north, to the everyday values, decision-making, and consequent practices of people in much of Africa. Using examples of Ebola, pandemic influenza, and tuberculosis, we illustrate how Ubuntu can be applied to tackle conflicting ethical problems in public health and medicine. (shrink)

This study critically examines the concept of benefit‐sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit‐sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit‐sharing across various statutes. This (...) reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit‐sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision‐making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit‐sharing in health research. (shrink)

Previous research has consistently highlighted the importance of stakeholder engagement in identifying and developing solutions to ethical challenges in genomic research, especially in Africa where such research is relatively new. In this paper, we examine what constitutes good ethical practice in research, from the perspectives of genomic research participants in Uganda. Our study was part of a multi-site qualitative study exploring these issues in Uganda, Ghana and Zambia. We purposively sampled various stakeholders including genomic research participants, researchers, research (...) class='Hi'>ethics committee members, policy makers and community members. This paper presents the findings from in-depth interviews with 27 people with diabetes who had participated in a diabetes genomic study. Data were collected using semi-structured interviews. Manual thematic content analysis was conducted using a framework approach. Findings indicate three key requirements that research participants see as vital for genomic research to be more responsive to research participants’ needs and contextual realities: de-emphasising the role of experts and institutions in the consenting process, clarity about the timing and nature of feedback both of findings relevant to the health of individuals and about the broad progress of the study, and more effective support for research participants during and after the study. (shrink)

Bioethics urges us to question and debate fundamental moral issues that arise in health-related sciences. However, as a result of Western dominance and globalization, bioethical thinking and practice has inevitably been shaped and defined by Western theories. With recent discussions centering on the relationship between culture and bioethics, it is important to consider how and to what extent can bioethics reflect and accommodate non-Western values and beliefs? Debatably, many scholars working in the field of ‘African bioethics’ seek to construct (...) a bioethical practice that is grounded in indigenous African values. Yet, how relevant are ancient African cultural norms to the lives and realities of the 21st century Sub-Saharan-Africans? This edited volume explores bioethics in Africa from pluralistic and inter-cultural perspectives. The selected papers offer diverse theoretical and practical perspectives on the bioethical challenges that are common and specific to the lives of Sub-Sahara Africans. The contributors define bioethics broadly (beyond ethical issues relating to biomedical and biotechnological science) to include applied ethics that concern all aspects of life. Multidisciplinary in approach, the contributions to this book consider bioethics in relation to philosophy, social work, psychiatry, African studies, religious studies, psychology, and medicine. The broad scope of this volume means it will be of interest to those studying and working in bioethics as well as the fields mentioned above. (shrink)

Global health research partnerships have many benefits, including the development of research capacity and improving the production and use of evidence to improve global health equity. These partnerships also include many challenges, with power and resource differences often leading to inequitable and unethical partnership dynamics. Responding to these challenges and to important gaps in partnership scholarship, the Canadian Coalition for Global Health Research conducted a three-year, multi-regional consultation to capture the research partnership experiences of stakeholders in South (...) Asia, Latin America, and sub-Saharan Africa. The consultation participants described persistent inequities in the conduct of global health research partnerships and called for a mechanism through which to improve accountability for ethical conduct within partnerships. They also called for a commitment by the global health research community to research partnership ethics. The Partnership Assessment Toolkit is a practical tool that enables partners to openly discuss the ethics of their partnership and to put in place structures that create ethical accountability. Clear mechanisms such as the PAT are essential to guide ethical conduct to ensure that global health research partnerships are beneficial to all collaborators, that they reflect the values of the global health endeavor more broadly, and that they ultimately lead to improvements in health outcomes and health equity. (shrink)

Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational (...) issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity. (shrink)

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider‐initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse (‘opt out’). While (...) these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of ‘provider‐initiated’ testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource‐poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS. (shrink)

The Experiment Must Continue is a beautifully articulated ethnographic history of medical experimentation in East Africa from 1940 through 2014. In it, Melissa Graboyes combines her training in public health and in history to treat her subject with the dual sensitivities of a medical ethicist and a fine historian. She breathes life into the fascinating histories of research on human subjects, elucidating the hopes of the interventionists and the experiences of the putative beneficiaries. Historical case studies highlight failed (...) attempts to eliminate tropical diseases, while modern examples delve into ongoing malaria and HIV/AIDS research. Collectively, these show how East Africans have perceived research differently than researchers do and that the active participation of subjects led to the creation of a hybrid ethical form. By writing an ethnography of the past and a history of the present, Graboyes casts medical experimentation in a new light, and makes the resounding case that we must readjust our dominant ideas of consent, participation, and exploitation. With global implications, this lively book is as relevant for scholars as it is for anyone invested in the place of medicine in society. (shrink)

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and (...) capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations. (shrink)

A complex network of ethico‐legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring (...) the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements. (shrink)

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 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. (shrink)

Smartphones with Global Positioning System (GPS) apps offer simple and accurate tools to collect data on human mobility. However, their associated ethical challenges remain to be assessed. We used the Emanuel framework to assess the ethical concerns of using smartphone GPS to record mobility patterns of young adults in rural South Africa for a larger study on mobility and HIV risk (Sesikhona). We conducted four focus groups (FGDs) with individuals eligible for the Sesikhona study. FGD data were coded using (...) the Emanuel framework. Participants perceived use of smartphone GPS to study human mobility and HIV risk as valuable. They raised concerns about invasion of privacy and confidentiality. Also mentioned were risk/benefit ratio, informed consent and ongoing respect. Concerns expressed provided a useful evidence-base for the development of a guide to inform future participants about ethical issues arising in the use of GPS technology to track mobility and health-related issues. (shrink)

BackgroundThe COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. (...) In this study, we aim to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa.MethodsTwenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses.ResultsKenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking.ConclusionsThis study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs. (shrink)

It is clear that corruption as the abuse of power is an enormous bioethical issue in the public health sector in SA, but as a challenge, it has not elicited much discussion from a global bioethical perspective. The Universal Declaration of Bioethics and Human Rights on corruption considers three matters. First, the existence of corruption as a problem of power is recognised in the health environment and condemned. Second, corruption is indicated as an immoral phenomenon that harms the (...) interests of the patient, ignores vulnerable people and neglects social responsibility. Third, it can be concluded that the UDBHR expresses the opinion that corruption has to be combated by a process of ethical decision-making, the use of ethics committees and ethics education. (shrink)

Despite decades of prevention efforts, millions of persons worldwide continue to become infected by the human immunodeficiency virus (HIV) every year. This urgent problem of global epidemic control has recently lead to significant changes in HIV testing policies. Provider-initiated approaches to HIV testing have been embraced by the Centers for Disease Control and Prevention and the World Health Organization, such as those that routinely inform persons that they will be tested for HIV unless they explicitly refuse ('opt out'). While (...) these policies appear to increase uptake of testing, they raise a number of ethical concerns that have been debated in journals and at international AIDS conferences. However, one special form of 'provider-initiated' testing is being practiced and promoted in various parts of the world, and has advocates within international health agencies, but has received little attention in the bioethical literature: mandatory premarital HIV testing. This article analyses some of the key ethical issues related to mandatory premarital HIV testing in resource-poor settings with generalized HIV epidemics. We will first briefly mention some mandatory HIV premarital testing proposals, policies and practices worldwide, and offer a number of conceptual and factual distinctions to help distinguish different types of mandatory testing policies. Using premarital testing in Goma (Democratic Republic of Congo) as a point of departure, we will use influential public health ethics principles to evaluate different forms of mandatory testing. We conclude by making concrete recommendations concerning the place of mandatory premarital testing in the struggle against HIV/AIDS. (shrink)

Background While community engagement is increasingly promoted in global health research to improve ethical research practice, it can sometimes coerce participation and thereby compromise ethical research. This paper seeks to discuss some of the ethical issues arising from community engagement in a low resource setting. Methods A qualitative study design focusing on the engagement activities of three biomedical research projects as ethnographic case studies was used to gain in-depth understanding of community engagement as experienced by multiple stakeholders in Malawi. (...) Data was collected through participant observation, 43 In-depth interviews and 17 focus group discussions with community leaders, research staff, community members and research participants. Thematic analysis was used to analyse and interpret the findings. Results The results showed that structural coercion arose due to an interplay of factors pertaining to social-economic context, study design and power relations among research stakeholders. The involvement of community leaders, government stakeholders, and power inequalities among research stakeholders affected some participants’ ability to make autonomous decisions about research participation. These results have been presented under the themes of perception of research as development, research participants’ motivation to access individual benefits, the power of vernacular translations to influence research participation, and coercive power of leaders. Conclusion The study identified ethical issues in community engagement practices pertaining to structural coercion. We conclude that community engagement alone did not address underlying structural inequalities to ensure adequate protection of communities. These results raise important questions on how to balance between engaging communities to improve research participation and ensure that informed consent is voluntarily given. (shrink)

Genomic and biobank research has undergone exponential growth in Africa. Traditionally this resulted in exploitative research practices in the form of so-called ‘parachute research’ with little or no consideration for capacity building. However there has been a recent growth of research and consortia where capacity building and equitable research have been a key objective of the research, and attention is now focused on the governance of this research. The importance of solidarity in genomic biobank research in high income countries (...) is well established and such an ethos reflects the communal based worldviews prevalent in many African communities. However, if the governance of the research is to foster equitable research practices, there must be some reciprocal benefit. This chapter will explore the impact that reciprocity will have on solidarity and how this may manifest in a governance framework in Africa. Particular focus will be given to capacity building and benefit sharing to enable the research to develop for the benefit of the local population, in a manner that promotes trust and fairness. This chapter will conclude with some recommendations on how to ensure reciprocity is enshrined in a governance framework for genomic biobank research in Africa. (shrink)

This article describes challenges of conducting an HIV prevention program involving 40 male and female participants ages 12–18 in Hammanskraal, South Africa, aimed at increasing awareness and knowledge of laws protecting children’s sexual health rights and access to services through a culturally based “study circle” format. Challenges highlighted by the project included Institutional Review Board approval of youth consent procedures, cooperation and coordination with local policymakers, the need to modify presentation materials to youths’ comprehension levels, availability of youth-based (...) sexual health service providers, and cultural ambiguity over parental involvement in youth health care decisions and laws pertaining to sexual relationships among minors. (shrink)

Public health interventions, particularly in low‐ and middle‐income countries (LMICs), are implemented with the never‐ending challenge of limited resources and the ever‐present challenge of choosing between interventions. While necessary, the application of ethical analysis is absent in most of such decision‐making, resulting in fewer favourable consequences. In applying ethical principles to the saving of women from the burden of cervical cancer, I argue in favour of saving statistical lives (investing in prevention) in LMICs, by mapping the principles of justice (...) in resource allocation to the prevailing circumstance. The key facts in this circumstance are that providing treatment (which is saving identified lives), involves mostly providing palliative treatment, which is associated with a high likelihood of death among the identified lives while undergoing treatment or shortly thereafter. I focus on the dilemma of having a national cancer prevention program versus the expansion of cancer treatment facilities. (shrink)

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

Ethical challenges surrounding the implementation of male circumcision as an HIV prevention strategyResearchers have been exploring the possibility of a correlation between male circumcision and lowered risk of HIV infection almost since the beginning of the HIV/AIDS epidemic.1 Results from a randomised controlled trial in South Africa in 2005 indicate that male circumcision protects men against the acquisition of HIV through heterosexual intercourse,2 confirming the findings from 20 years of observational studies.3 Circumcised men in the South African trial were (...) 60% less likely to acquire HIV than their uncircumcised counterparts. A mathematical modelling study, based on the South African trial, estimates that the practice of male circumcision could avert two million new HIV infections and 300 000 HIV-related deaths over the next 10 years in sub-Saharan Africa.4 More recently, two randomised controlled trials in Kisumu, Kenya and Rakai, Uganda showed, respectively, 53% and 48% reductions in HIV acquisition among circumcised men than uncircumcised men in the trial.5 These results strongly suggest that male circumcision could play an important role in the struggle against the continued rise in new HIV infections. However, as observers noted at the 2006 XVI International AIDS Conference in Toronto, Canada, excitement about the potential epidemiological impact has overshadowed the debate over the difficult translation of research on male circumcision, into policy and practice.6 Similar calls for caution have been raised before and elsewhere.7,8The topic of male circumcision carries an enormous amount of ethical baggage. Male infants, worldwide, are circumcised for various medical, social and/or religious reasons. Circumcision is a cultural act and a surgical procedure; medical reasons are not the only reasons to circumcise that people have found and continue to find as compelling. Benatar and Benatar9 have argued that—when …. (shrink)

Livestock are important assets in Africa, helping improve the nutritional status of their owners, and contributing to economic growth. Can these roles continue and can livestock production systems be further developed so that they will be sustainable? A key feature of livestock in Africa is that they fulfill multiple roles, ranging from draught power, to providing manure, milk, and meat. Constraints to increasing productivity include both physical and institutional. In the former category, constraints to adopting draught power include (...) insufficient numbers at the individual household level. Lack of adequate pasture is probably the most important constraint. Diseases are also notable constraints to improving productivity, particularly those categorized as Group I (highly contagious — e.g., rinderpest) or Group II (vector-borne parasitic and viral—e.g., trypanosomiasis). Institutional constraints include lack of research and market distortions. To improve productivity, at the macroeconomic level, governments must continue or start policies aimed at liberalizing markets and revaluing exchange rates. Also, research institutions need an increase in funding for periods of ten or more years. Research and other livestock institutions may be able to leverage limited resources by forming more collaborative relationships at the regional level. Research priorities include breeding on specific aspects, such as increased milk production. However, it must be realized that breeding programs have an inherent problem in disseminating improved breeds in a rapid and equitable manner. Quality of pasture may be improved by further research on more accurately calculating stocking rates and on developing mechanisms to control numbers on pastures (e.g., community controlled grazing schemes). Other research priorities include new technologies to improve animal health, funding of micro-enterprises to add value to livestock products, and market information systems for small-scale farmers. Schemes to increase livestock production in Africa will only occur if innovations closely match the local sets of circumstances. Given the multiple roles of livestock, research into innovations that local communities will readily adopt must take a systems approach. (shrink)