This special issue of the Journal Law, Medicine & Ethics takes up the concern of informed consent, particularly in times of controversy. The dominant moral dilemmas that frame traditional bioethical concerns address medical experimentation on vulnerable subjects; physicians assisting their patients in suicide or euthanasia; scarce resource allocation and medical futility; human trials to develop drugs; organ and tissue donation; cloning; xenotransplantation; abortion; human enhancement; mandatory vaccination; and much more. The term “bioethics” provides a lens, language, and guideposts to the (...) study of medical ethics. It is worth noting, however, that medical experimentation is neither new nor exclusive to one country. Authors in this issue address thorny subjects that span borders and patients: from matters dealing with children and vaccination to the language and perception of consent. (shrink)

I seek to advance enquiry into the philosophical question of in virtue of what human beings have a dignity of the sort that grounds human rights. I first draw on values salient in sub-Saharan African moral thought to construct two theoretically promising conceptions of human dignity, one grounded on vitality, or liveliness, and the other on our communal nature. I then argue that the vitality conception cannot account for several human rights that we intuitively have, while the community conception can (...) do so. I conclude that, of plausible theories of human dignity with an African pedigree, the field ought to favour a community-based view and critically compare it in future work with the Kantian, autonomy-based view that dominates Western thinking about dignity. (shrink)

BackgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.MethodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.ResultsWe identified three main categories of arguments for the acceptability of (...) a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.ConclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB. (shrink)

Nigeria is experiencing, together with the rest of the world, consequences of relentlessly accelerating technological developments, in the contexts of relative lagging of developments in the Humanities, new discoveries in sciences and technological innovations, advances in medicine, changes in government policies and norms, rapid changes in the society, unhealthy practices in the area of food and agriculture, degradation of the environment as well as climate change. Furthermore, Nigeria as a Member State of UNESCO Bioethics is expected to have a National (...) Bioethics Committee to enhance her participation in global concerns, as well as increase her opportunities to tap into global Bioethics resources. For this Committee to be established, the National Bioethics Framework and Policy Documents must be put in place. This paper discusses the rigorous process of developing the National Bioethics Framework and the National Bioethics Policy Documents as well as the need for a National Bioethics Committee in Nigeria. (shrink)

After 4 years of relief activities, it is difficult to keep managing the lead poisoning epidemic in northern Nigeria as an emergency situation, while it appears clearly to be a more complex, widespread and chronic public health issue than anticipated. Making the continuing treatment of children conditional upon commitments from impacted families to adhere to safe mining practices is unlikely to bring about any long-term benefit. This is because such commitment is ultimately not in the hands of the victims or (...) their families. Demands for better collaboration from the affected communities should take into account local power imbalances and broader networks of human exploitation, which are the ultimate causes of the outbreak. (shrink)

BackgroundThe COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for (...) a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa.MethodsWe conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60–125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data.ResultsFive main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme.ConclusionsNumerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues. (shrink)