Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model.Empirical studies show (...) that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences.Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians’ behaviors. (shrink)

Studies on informed consent to medical research conducted in low or middle-income settings have increased, including empirical investigations of consent to genetic research. We investigated voluntary participation and comprehension of informed consent among women involved in a genetic epidemiological study on breast cancer in an urban setting of Nigeria comparing women in the case and control groups.

The severe shortage of organs for transplantation and the continual reluctance of the public to voluntarily donate has prompted consideration of alternative strategies for organ procurement. This paper explores the development of market approaches for procuring human organs for transplantation and considers the social and moral implications of organ donation as both a gift of life and a commodity exchange. The problematic and paradoxical articulation of individual autonomy in relation to property rights and marketing human body parts is addressed. We (...) argue that beliefs about proprietorship over human body parts and the capacity to provide consent for organ donation are culturally constructed. We contend that the political and economic framework of biomedicine, in western and non-western nations, influences access to transplantation technology and shapes the form and development of specific market approaches. Finally, we suggest that marketing approaches for organ procurement are and will be negotiated within cultural parameters constrained by several factors: beliefs about the physical body and personhood, religious traditions, economic conditions, and the availability of technological resources. (shrink)

In the field of bioethics, scholars have begun to consider carefully the impact of structural issues on global population health, including socioeconomic and political factors influencing the disproportionate burden of disease throughout the world. Human rights and social justice are key considerations for both population health and biomedical research. In this paper, I will briefly explore approaches to human rights in bioethics and review guidelines for ethical conduct in international health research, focusing specifically on health research conducted in resource-poor settings. (...) I will demonstrate the potential for addressing human rights considerations in international health research with special attention to the importance of collaborative partnerships, capacity building, and respect for cultural traditions. Strengthening professional knowledge about international research ethics increases awareness of ethical concerns associated with study design and informed consent among researchers working in resource-poor settings. But this is not enough. Technological and financial resources are also necessary to build capacity for local communities to ensure that research results are integrated into existing health systems. Problematic issues surrounding the application of ethical guidelines in resource-poor settings are embedded in social history, cultural context, and the global political economy. Resolving the moral complexities requires a commitment to engaged dialogue and action among investigators, funding agencies, policy makers, governmental institutions, and private industry. (shrink)

Most writing on informed consent in Africa highlights different cultural and social attributes that influence informed consent practices, especially in research settings. This review presents a composite picture of informed consent in Nigeria using empirical studies and legal and regulatory prescriptions, as well as clinical experience. It shows that Nigeria, like most other nations in Africa, is a mixture of sociocultural entities, and, notwithstanding the multitude of factors affecting it, informed consent is evolving along a purely Western model. Empirical studies (...) show that 70–95% of Nigerian patients report giving consent for their surgical treatments. Regulatory prescriptions and adjudicated cases in Nigeria follow the Western model of informed consent. However, adversarial legal proceedings, for a multiplicity of reasons, do not play significant roles in enforcing good medical practice in Nigeria. Gender prejudices are evident, but not a norm. Individual autonomy is recognized even when decisions are made within the family. Consent practices are influenced by the level of education, extended family system, urbanization, religious practices, and health care financing options available. All limitations notwithstanding, consent discussions improved with increasing level of education of the patients, suggesting that improved physician's knowledge and increasing awareness and education of patients can override other influences. Nigerian medical schools should restructure their teaching of medical ethics to improve the knowledge and practices of physicians. More research is needed on the preferences of the Nigerian people regarding informed consent so as to adequately train physicians and positively influence physicians' behaviors. (shrink)

The emergence of new obstetrical and neonatal technologies, as well as more aggressive clinical management, has significantly improved the survival of extremely low birth weight infants. This development has heightened concerns about the limits of viability. ELBW infants, weighing less than 1,000 grams and no larger than the palm of one's hand, are often described as of late twentieth century technology. Improved survivability of ELBW infants has provided opportunities for long-term follow-up. Information on their physical and emotional development contributes to (...) developing standards of practice regarding their care. (shrink)

Cultural difference has been largely ignored within bioethics, particularly within the end-of-life discourses and practices that have developed over the past two decades in the U.S. healthcare system. Yet how should culturebe taken into account?

In June 1993, conjoined twins Amy and Angela Lakeberg became the focus of national attention. They shared a complex six‐chambered heart and one liver; only one could survive separation surgery, and even her chances were slim. The medical challenge was great and the ethical challenges were even greater.

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. (shrink)

The exportation of Western biomedicine throughout the world has not resulted in a systematic homogenization of scientific ideology but rather in the proliferation of many forms and practices of biomedicine. Similarly, in the last decade, bioethics has become increasingly an international enterprise. Although there may be consensus regarding the inherent value of ethical discourse as it relates to health and medical care, there are disagreements about the nature and parameters of medical morality. This lack of consensus exists because our beliefs (...) about morality are culturally constituted, embedded in social, religious, and political ideologies that influence particular individuals and communities at specific historical moments. (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an (...) interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

The exportation of Western biomedicine throughout the world has not resulted in a systematic homogenization of scientific ideology but rather in the proliferation of many forms and practices of biomedicine. Similarly, in the last decade, bioethics has become increasingly an international enterprise. Although there may be consensus regarding the inherent value of ethical discourse as it relates to health and medical care, there are disagreements about the nature and parameters of medical morality. This lack of consensus exists because our beliefs (...) about morality are culturally constituted, embedded in social, religious, and political ideologies that influence particular individuals and communities at specific historical moments. (shrink)

The use of nonhuman animals in research has long been a source of bioethical and scientific debate. We consider the oversight and use of nonhuman animals in chimeric research. We conducted interviews with twelve members of embryonic stem cell research oversight committees, nine members of institutional animal care and use committees, and fourteen scientists involved in human–nonhuman‐animal chimeric research in different areas of the United States. Interviews addressed animal welfare and conceptual issues associated with moral status and humanization of nonhuman (...) animals that contain human cells. Our findings suggest that concepts of enhanced moral status and consciousness are not very useful in human–nonhuman‐animal chimeric research in part because their meanings are not easily defined, which presents challenges to applying the concepts in research. Instead, scientists and oversight committee members we interviewed seemed to rely on standard assessments of changes in animal welfare when focusing on the ethics of human‐animal chimeric research. (shrink)

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

The rise of genomic studies in Africa – not least due to projects funded under H3Africa – is associated with the development of a small number of biorepositories across Africa. For the ultimate success of these biorepositories, the creation of cell lines including those from selected H3Africa samples would be beneficial. In this paper, we map ethical challenges in the creation of cell lines.

Presents a plethora of approaches to developing human potential in areas not conventionally addressed. Organized in two parts, this international collection of essays provides viable educational alternatives to those currently holding sway in an era of high-stakes accountability.

Community engagement has been recognised as an important aspect of the ethical conduct of biomedical research, especially when research is focused on ethnically or culturally distinct populations. While this is a generally accepted tenet of biomedical research, it is unclear what components are necessary for effective community engagement, particularly in the context of genomic research in Africa.

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:The World According to Kant: Appearances and Things in Themselves in Critical Idealism by Anja JauernigPatricia KitcherAnja Jauernig. The World According to Kant: Appearances and Things in Themselves in Critical Idealism. Oxford: Oxford University Press, 2021. Pp. 400. Hardback, $105.00.After Peter Strawson's withering criticisms of the "Metaphysics of Transcendental Idealism" in The Bounds of Sense (London: Methuen, 1966), many Kant scholars devoted their labors to explaining and expanding (...) his project of transcendental epistemology. Recently, however, the tide has turned, and major Kant scholars have tried to fathom the intricacies of his metaphysical doctrines. With its new, systematic, and boldly idealistic interpretation of transcendental idealism, Anja Jauernig's The World According to Kant is an important contribution to this literature.Jauernig casts her reading of Kantian metaphysics in relation to two traditional accounts: the two-world interpretation that seemed obvious to Kant's first readers, and the two-aspect interpretation offered by Gerald Prauss (Kant und das Problem der Dinge an sich [Bonn: Bouvier Verlag, 1974]) and Henry Allison (Kant's Transcendental Idealism: An Interpretation and Defense [New Haven, CT: Yale University Press, 1983]). On the second reading, there are not two sets of objects, one phenomenal and one noumenal, but just one set that can be regarded in two different ways. Jauernig effectively demolishes the original two-aspect reading, noting that it has the consequence that contradictory properties (being F and not being F) are attributed to the same thing (164). The serious competitor to her interpretation is a more recent reading that makes an analogy with secondary qualities. Rae Langton introduces this strategy in Kantian Humility (Oxford: Oxford University Press, 1998), and Lucy Allais offers a new version of it in Manifest Reality (Oxford: Oxford University Press, 2015). On Allais's version, the properties of empirical objects are real, but unusual. As the redness of a rose depends not just on the existence of the rose, but also on the existence of perceivers with retinal cones, the properties of empirical objects depend on cognitive subjects as well on as things in themselves. Jauernig takes Allais's secondary quality analogy and a closely [End Page 160] related view of Tobias Rosefeldt's as her principal foils and marshals many texts to support her new view. To my mind, however, some of the cited texts seem ambiguous, for example, "our sensible representation is in no way a representation of things in themselves, but merely of the manner in which they appear to us" (Ak. 4:287, cited on 256n22). The second part of the citation seems to imply that sensible representations are how things in themselves are "manifest" to us, as Allais would put it.Jauernig would focus on the first part of the citation: a sensible representation in no way represents the thing in itself. In her view, empirical objects or appearances are fully mind-dependent: each of their "ontological ingredients" (elements that make up an object) is mind-dependent. Since empirical objects are fully mind-dependent and things in themselves are mind-independent, they have no "ontological overlap" (32). Phenomena and noumena are therefore numerically distinct things (32). Appearances or empirical objects are "empirically real" (as opposed to illusory), not merely because they agree with the formal conditions of reality, but because cognition begins with the receipt of sensations through the affection of human sensibility by things in themselves. (Here Jauernig's appearances that are grounded in real things but have properties that are "fully" mind-dependent seem similar to Allais's appearances.) Because objects of empirical cognition involve sensations caused by things in themselves, they should be understood as existents, even though they are not part of "fundamental ontology," whose denizens are mind-independent. Appearances exist or perhaps "in-exist" only as "intentional objects" of representations (33). On Kant's theory, as on Leibniz's, there are different levels of reality (39–40).Jauernig energetically engages challenges confronting her strongly idealistic reading. If empirical objects are fully mind-dependent, how do they differ from illusions and fictions? Since Kant anchors empirical reality to empirical intuition, the question becomes, how are appearances or empirical objects the referents of empirical intuitions? Appearances are... (shrink)

We use Homer and Sun Tzu as a background to better understand and reformulate confrontation, anger and violence in medicine, contrasting an unproductive ‘love of war’ with a productive ‘art of war’ or ‘art of strategy’. At first glance, it is a paradox that the healing art is not pacific, but riddled with militaristic language and practices. On closer inspection, we find good reasons for this cultural paradox yet regret its presence. Drawing on insights from Homer's The Iliad and The (...) Odyssey, we argue for better understanding of confrontation, anger, bullying, intimidation and violence in medicine in order to change the culture. For example, equating medicine with war is not a given condition of medicine but a convenient metaphor with historical origins and a historical trajectory. Other, non-martial metaphors, such as medicine as collaboration, may be more appropriate in an age of team-based care. Taking lessons from Homer, we suggest three key ways in which cold-hearted confrontation and anger in medicine can be transformed into productive, warm-hearted engagement: the transformation of angry impulse into reflection, moral courage and empathy. Thinking with Homer can offer an aesthetically and morally charged alternative to the current body of literature on topics, such as anger in doctors, and how this may be ‘managed’, without recourse to an instrumental economy where emotions are viewed as commodities, and emotional responses can be ‘trained’ through communication skills courses. (shrink)

Gottlob Frege famously rejects the methodology for consistency and independence proofs offered by David Hilbert in the latter's Foundations of Geometry. The present essay defends against recent criticism the view that this rejection turns on Frege's understanding of logical entailment, on which the entailment relation is sensitive to the contents of non-logical terminology. The goals are (a) to clarify further Frege's understanding of logic and of the role of conceptual analysis in logical investigation, and (b) to point out the extent (...) to which his understanding of logic differs importantly from that of the model-theoretic tradition that grows out of Hilbert's work. (shrink)

This paper examines the connection between model-theoretic truth and necessary truth. It is argued that though the model-theoretic truths of some standard languages are demonstrably ''''necessary'''' (in a precise sense), the widespread view of model-theoretic truth as providing a general guarantee of necessity is mistaken. Several arguments to the contrary are criticized.

This paper defends the view that Frege’s reduction of arithmetic to logic would, if successful, have shown that arithmetical knowledge is analytic in essentially Kant’s sense. It is argued, as against Paul Benacerraf, that Frege’s apparent acceptance of multiple reductions is compatible with this epistemological thesis. The importance of this defense is that (a) it clarifies the role of proof, definition, and analysis in Frege’s logicist works; and (b) it demonstrates that the Fregean style of reduction is a valuable tool (...) for those who would investigate the nature of arithmetical knowledge. (shrink)

The primary purpose behind effectiveness research is to determine whether a treatment with demonstrated efficacy has utility when administered to the general population. The main questions these studies are meant to answer are these: Can the typical patient respond to treatment? Is the treatment acceptable to the typical patient? Can the treatment be administered safely and in its entirety in the typical treatment setting? Is the treatment under study significantly better than the community standard of care both from a cost (...) and outcome perspective? Answering these questions is meant to provide sufficient information to providers and policymakers so that effective interventions can be adopted and become the new community standard. For this research to make a meaningful impact on a provider and policymaker's decision to change the status quo, study interventions should be compared to the existing community standard of treatment, often referred to as treatment as usual (TAU). From an ethical perspective, this decision may not always be the safest choice. In some populations, TAU may mean no treatment at all, and in others TAU may be worse than withholding treatment. The effectiveness researcher is then caught between the pull to do no harm and the need for research to have an impact on change. The purpose of this article is to highlight certain conditions when TAU is ethically acceptable and to discuss alternatives when TAU may be an unethical treatment condition. For purposes of precision, we focus exclusively on psychotherapy effectiveness research rather than system-intervention research or medication-intervention research. (shrink)

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should consider when (...) developing psychosocial interventions studies that include ethnic minorities. (shrink)

This thesis is an examination of Frege's logicism, and of a number of objections which are widely viewed as refutations of the logicist thesis. In the view offered here, logicism is designed to provide answers to two questions: that of the nature of arithmetical truth, and that of the source of arithmetical knowledge. ;The first objection dealt with here is the view that logicism is not an epistemologically significant thesis, due to the fact that the epistemological status of logic itself (...) is not well understood. I argue to the contrary that on Frege's conception of logic, logicism is of clear epistemological importance. ;The second objection examined is the claim that Godel's first incompleteness theorem falsifies logicism. I argue that the incompleteness theorem has no impact on logicism unless the logicist is compelled to hold that logic is recursively enumerable. I argue, further, that there is no reason to impose this requirement on logicism. ;The third objection concerns Russell's paradox. I argue that the paradox is devastating to Frege's conception of numbers, but not to his logicist project. I suggest that the appropriate course for a post-Fregean logicist to follow is one which divorces itself from Frege's platonism. ;The conclusion of this thesis is that logicism has of late been too easily dismissed. Though several critical aspects of Frege's logicism must be altered in light of recent results, the central Fregean thesis is still an important and promising view about the nature of arithmetic and arithmetical knowledge. (shrink)

Initiated by Robert Wesson, _Evolution and Human Values_ is a collection of newly written essays designed to bring interdisciplinary insight to that area of thought where human evolution intersects with human values. The disciplines brought to bear on the subject are diverse - philosophy, psychiatry, behavioral science, biology, anthropology, psychology, biochemistry, and sociology. Yet, as organized by co-editor Patricia A. Williams, the volume falls coherently into three related sections. Entitled Evolutionary Ethics, the first section brings contemporary research to an (...) area first explored by Herbert Spencer. Evolutionary ethics looks to the theory of evolution by natural selection to find values for human living. The second section, Evolved Ethics, discusses the evolution of language and religion and their impact on moral thought and feeling. Evolved ethics was partly Charles Darwin's subject in _The Descent of Man._ The last section bears the title Scientific Ethics. A nascent field, scientific ethics asks about the evolution of human nature and the implications of that nature for ethical theory and social policy. Together, the essays collected here provide important contemporary insights into what it is - and what it may be - to be human. (shrink)

A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.