Revision of a self-assessment tool for research ethics committees in low- and middle-income countries: Incorporation of elements that safeguard participants' rights and welfare
Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self-Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare. To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences. We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.
Adults aged 65 years and older in South Africa have a responsibility to vaccinate against influenza
In this article, we draw on the thinking about incompleteness and conviviality grounded in Afro-communitarianism ethics from the Global South to argue that adults aged 65 years and above have a prima facie responsibility to vaccinate against influenza. Notably, adults aged 65 years and above have a duty of conviviality to act in ways that limit harm to them and others. This article is intrinsically valuable to promote epistemic justice, thereby contributing towards the decolonisation of the global healthcare system. Moreover, this project has social significance in contributing to mitigation efforts against future public health challenges associated with population ageing in resource-limited developing African nations, wherein the impact of population transition will be felt most.
Scoping review of the ethical regulations for Alzheimer's Disease and Alzheimer's Disease Related Dementia research in Africa
We conducted a scoping review to ascertain the landscape of ethics regulations for AD/ADRD research in Africa using Arksey and O'Malley's framework. We sourced regulations from the International Compilation of Human Research Standards. We included regulations from 14 countries published between 1997 and 2020. Provisions in the regulations applicable to research in AD/ADRD were part of broader sub-provisions for research such as with persons under legal disability. Regulations mostly required the appointment of Legally Authorised Representatives, as a major protection for persons with AD/ADRD. Provisions supporting capacity assessment and advance directives were only provided in regulations from five and two countries respectively. No regulation cited the Convention on the Rights of Persons with Disabilities as a foundational instrument for its provisions. In conclusion, regulations specifically applicable to research among AD/ADRD or other cognitively impaired persons in Africa are scarce and provisions in existing regulations mostly lack specificity for practical implementation.
Indigenous Peoples' human genomic sovereignty: Lessons for Africa
Human genomics research with indigenous peoples has often been characterised by tension between the 'western' science ideologies and indigenous peoples' cultural beliefs in relation to their human genetic resources and data. This article explores this tension from the lens of the concept of indigenous peoples' human genomic sovereignty and tests the applicability of the concept in Africa. The article achieves this by first highlighting the tension between 'western' science and indigenous peoples through three case studies from Canada, the USA, and South Africa. It then analyses indigenous peoples' human genomic sovereignty in the USA and Canada and compares it with the notion of indigenous peoples' sovereignty in Africa. The article concludes by highlighting lessons that indigenous groups in Africa can draw from the USA and Canada in their quest for human genomic sovereignty.
Moral challenges and understanding of clinical ethics in Tanzanian hospitals: Perspectives of healthcare professionals
Healthcare professionals encounter many moral challenges in their daily clinical practice. However, there have been few studies on the subject matter in Tanzania. This study aims to provide an account of moral challenges faced by healthcare professionals in Tanzanian hospitals, their understanding of clinical ethics, and the ethics education they have received. Many participants reported receiving some kind of ethics training through formal education and on-the-job training. Some participants understood ethics in healthcare settings as adherence to established laws, regulations, guidelines, procedures, norms, and rules essential in clinical practice. Analysis of the data identified four themes of moral challenges. These challenges are related to 1) decision-making and communication in clinical practice, 2) scarcity of medical resources and prioritization in clinical practice, 3) withdrawal of curative treatment, and 4) conflicts between professional judgment, religious convictions and adherence to alternative treatments. Based on the findings, we suggest a context-sensitive form of clinical ethics training to prepare healthcare professionals to recognize and address these moral challenges.
From COVID-19 to mpox vaccine hoarding - Has the Global North learned its global health lessons?
Social disharmony, inauthenticity and patriarchy: an Ubuntu perspective on the practice of female genital mutilation
Female Genital Mutilation (FGM) is a universal issue which affects girls in Africa, the Middle East, Asia and South America, and immigrant communities in Western Europe, North America, Australia and New Zealand. FGM is a cultural practice in approximately 29 countries in Africa, affecting over 140 million girls. FGM is practiced as a rite of passage, where girls are initiated into womanhood. This practice is promoted as a means for incorporation, thus ascribing personhood, and belonging for girls to their communities. African scholars hold conflicting positions about FGM, with some arguing that it is essential for relational fullness and harmony. While others believe FGM is unjustified because of the health and social risks associated with the practice. We argue, applying sustainable social harmony and Gyekye's views on cultural revitalization, that FGM is morally unjustified and should be prohibited. We believe the claims that FGM fosters harmony, a value of Ubuntu, are fallacious, and this perceived harmony is pretentious and unsustainable. We claim that FGM is inauthentic, unjust and steeped in patriarchal underpinnings that are unsustainable, thus it is a disharmonious practice. Cultural practices that are disharmonious should be refined and pruned and must be dynamic and responsive to current realities.
Ethical analysis of informed consent methods in longitudinal cohort studies: A Chinese perspective
In longitudinal cohort studies involving large populations over extended periods, informed consent entails numerous urgent challenges. This paper explores challenges regarding informed consent in long-term, large-scale longitudinal cohort studies based on the longitudinal and dynamic nature of such research. It analyzes and evaluates widely recognized broad consent and dynamic consent methods, highlighting limitations concerning their ability to adapt to evolving research objectives and participant perspectives. This paper discusses trust-based informed consent and emphasizes the needs to establish and maintain trust with research participants and to balance information disclosure with respect for participants' autonomy. Informed consent in long-term studies is an evolving process that must adapt to changing research environments. Based on participant trust, researchers should observe and assess potential research risks. Finally, the paper recommends enhancing institutional credibility, implementing reconsent procedures, and ensuring robust ethical oversight to safeguard participants' rights despite the complexity of modern biomedical research.
The Letter to the Editor as a tool to promote critical thinking in Latin American bioethics pedagogy
Personhood: An emergent view from Africa and the West
African understandings of personhood are complex, with different accounts emphasizing distinct aspects of what it means to be a person. Some accounts stress excellence of character and performing well in social roles and relationships, while others focus on innate moral qualities of individuals independent of their conduct and character. This paper sheds new light on these twin aspects of personhood. It proposes a way to navigate these dual features by bringing African and Western personhood into conversation, building on the strengths of each approach, and developing a new view of personhood that we call, Emergent Personhood. Section 1 introduces diverse approaches to personhood within African thought. Section 2 compares African and Western approaches. Section 3 evaluates advantages and disadvantages of each and identifies conditions that any account of personhood must meet to leverage the advantages and avoid the disadvantages identified. Section 4 introduces Emergent Personhood, which meets these conditions. Section 5 concludes that expanding the conversation about personhood across cultures enriches an ongoing conversation about what it means to be a person.
Analysis of the legal situation regarding euthanasia in Ecuador, Colombia, and Peru: Towards a Latin American model of medical assistance in dying?
Colombia was one of the first countries to decriminalise euthanasia. However, what is known in the international academic literature about the country's regulations is scarce and outdated. Such lack of information on the situation in Latin America is even more evident in the case of Peru, where the Lima Superior Court of Justice set a precedent by allowing a person to have access to euthanasia in 2021. Ecuador, which has just decriminalised euthanasia for all its citizens in February 2024, risks being similarly absent from the international dialogue. This article summarises for the first time all the regulations in force regarding euthanasia in Latin America, through a study of primary sources in Spanish, and analyses some of the convergences between these three neighbouring countries.
Modifications to consent documentation with adults with communication disorders following brain injury: An exploratory study
Consent documentation for research studies is often inaccessible to people with neurogenic communication disorders following brain injury and there is limited literature on specific modifications for informed consent. This exploratory study aimed to identify effective strategies and modifications to consent processes for adults with brain injury. Using a fictitious research study, we developed a set of Participant Information Sheets (PISs) varying in complexity, presentation format, and communication modality. Evaluations were conducted with eight participants. Findings indicated diverse participant preferences for PIS modifications, suggesting simplified vocabulary, reduced text, carefully selected images, and an interactive presentation modality as helpful strategies. Building on previous literature, we present refined guidelines for consent modifications for adults with neurogenic communication disorder after brain injury. These guidelines can promote more appropriate inclusion of communicatively impaired populations in research and assist ethics committees and researchers in preparing modified consent documents.
Factors associated with Saudi physicians' utilization of clinical ethics consultation services
Clinical Ethics Consultation (CEC) aims to resolve ethical dilemmas at the bedside. Through a structured process, CEC allows practitioners and patients to consult ethicists at times of moral conflict or uncertainty. Over the past few decades, CEC has become an invaluable part of healthcare practice. In Saudi Arabia, however, CEC services remain inexplicably underutilized. This study attempts to understand the factors associated with Saudi physicians' utilization of CEC to better meet the needs of practitioners and patients. Results indicate that although physicians routinely experience moral dilemmas, they seldom request a CEC. This is not due to unfamiliarity, lack of accessibility, or suspicion of ethical expertise. Rather, reluctance is likely due to an ingrained medical cultural stronghold that pressures practitioners to act heroically, and to resolve ethical dilemmas independently. Recommendations to improve the utilization of CEC services include wider availability, active collaborations with clinical practitioners, routine quality improvements, and managerial and national support.
The difficult path to euthanasia in Ecuador: A call for actions for other nations
The ethics of research informed consent from the Kyrgyz perspective: A qualitative study
To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in-depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision-making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz people have a distinctive decision-making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio-cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries.
Benefit-sharing with human participants in health research in South Africa: A call for clarity
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.
The informed consent process: An evaluation of the challenges and adherence of Ghanaian researchers
This study assessed challenges faced by researchers with the informed consent process (ICP). In-depth interviews were used to explore challenges encountered by Investigators, Research assistants, Institutional Review Board members and other stakeholders. An electronic questionnaire was also distributed, consisting of Likert-scale responses to questions on adherence to the ICP, which were derived from the Helsinki Declaration and an informed consent checklist of the US Department of Health and Human Research (HSS). Responses were weighted numerically and scores calculated for each participant. The median score of the level of adherence to the informed consent process was 93%. Most of the respondents (60%) cited the lack of time for the ICP to be a challenge, with 65% indicating a lengthy consent document to be the main challenge with the informed consent document. Challenges with language and communication were the dominant theme among informants. Despite the high adherence of Ghanaian researchers and research assistants to the ICP, challenges are still prevalent, requiring diligent and continuous efforts in research implementation.
A survey of the allocation of scarce resources in Türkiye during the COVID-19 pandemic: Which criteria did healthcare professionals prioritize?
COVID-19 caused an imbalance between medical resources and the number of patients in Türkiye like in many countries. There was not pandemic-triage system, and this situation led to decision making based on experience, intuition, and judgment of allocation of scarce resources. The research explains the guiding criteria that healthcare professionals used to prioritize the distribution of scarce medical resources during the COVID-19 pandemic. The criteria preferred by 928 healthcare professionals were evaluated when preventive measures for COVID-19 were reduced and so the number of cases increased rapidly. The results indicate that Turkish healthcare professionals largely support the utilitarian approach, which focuses on medical benefit in pandemic. The main problem was that some criteria not approved in COVID-19 triage guidelines were considered important by healthcare professionals. These criteria, which cause discrimination by preventing the provision of fair and equal medical care to patients, are a prominent issue in the study.
Biomedical research on autism in low- and middle-income countries: Considerations from the South African context
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by social/communicative difficulties and perseverative behaviours. While research on autism has flourished recently, few studies have been conducted on the disorder in non-Western contexts. In low- and middle-income countries (LMICs), biomedical research on autism is required to better understand the needs of the population and to develop contextually appropriate interventions. However, autistic individuals are a vulnerable study population and LMICs present with various considerations. While the presentation of autism is heterogeneous, stigma is a common social consequence affecting research. Drawing specifically on the South African context, the ethical intersections of these issues are discussed, along with the limitations of the current informed consent process. Community engagement is recommended as an adjunct to informed consent to ensure that biomedical research is conducted in a more inclusive way. Practical pointers are provided for implementing systematic support for conducting community engagement alongside biomedical research.