In this paper, we describe the potential role laypersons on ethics committees can play in ensuring community concerns are addressed in the design and implementation of genomic research. We draw inferences from the outcome of an empirical study of the impact of training of laypersons to address community engagement issues in ethics review of research protocol. While this paper does not advocate a particular solution, it describes the importance of community engagement in genomic research, the current limitations there are in (...) engaging communities in the design of these research projects and how communities can be indirectly engaged in the design and implementation of genomic research through the engagement of laypersons on ethics committees. However, to ensure that these laypersons can play this role, their capacity needs to be built to play this role appropriately. There is evidence to show that where resources are invested in building the capacity of laypersons to play their role as community ‘watchdogs’ in research, they play this role aptly. Community engagement is important in genomic research as genomic researchers will increasingly require community perspectives in critical ethics decision making. (shrink)

Volume 31, Issue 1, December 2020, Page 47-66.

COVID‐19, caused by a novel coronavirus named SARS‐CoV‐2, was identified in December 2019, in Wuhan, China. It was first confirmed in sub‐Saharan Africa in Nigeria on 27 February 2020 and has since spread quickly to all sub‐Saharan African countries, causing more than 111,309 confirmed cases and 2,498 deaths as of 03 June 2020. The lessons learned during the recent Ebola virus disease (EVD) outbreaks in some sub‐Saharan African countries were expected to shape and influence the region’s responses to COVID‐19 pandemic. (...) However, some of the challenges associated with the management of the EVD outbreaks persist and create obstacles for the effective management of the COVID‐19 pandemic. This article describes the commonalities between the EVD epidemics and COVID‐19 pandemic, with a view to draw on lessons learned to effectively tackle the ongoing pandemic. Key successes, failures and lessons learned from previous EVD outbreaks are discussed. Recommendations on how these lessons can be translated to strengthen the COVID‐19 response in sub‐Saharan Africa are provided. (shrink)

In 2004, the first ever multi‐sited clinical trials studied the prospect of HIV biomedical prevention (referred to as pre‐exposure prophylaxis—‘PrEP’). The trials were implemented at several international sites, but many officially closed down before they completed. At most sites, both scientists and community AIDS advocates raised concerns over the ethics and scientific rationales of the trial. Focusing on the Nigerian trial site, we detail the controversy that emerged among mostly Nigerian research scientists who scrutinized the research design and protocol. While (...) some of the disputes, especially those pertaining to community engagement mechanisms, were ultimately resolved in international fora and implemented in later PrEP trials, concerns over science rationales and assumptions were never addressed. We argue that scientific rationales should be treated as ethical concerns and suggest that such concerns should be deliberated at host sites before the trial protocol is finalized. (shrink)

The history of human subjects research and controversial procedures in relation to it has helped form the field of bioethics. Ethically questionable elements may be identified during research design, research implementation, management at the study site, or actions by a study’s investigator or other staff. Post-approval monitoring (PAM) may prevent violations from occurring or enable their identification at an early stage. In U.S.-initiated human subjects research taking place in resource-constrained countries with limited development of research regulatory structures, arranging a site (...) visit from a U.S. research ethics committee (REC) becomes difficult, thus creating a potential barrier to regulatory oversight by the parent REC. However, this barrier may be overcome through the use of digital technologies, since much of the world has at least remote access to the Internet. Empirical research is needed to pilot test the use of these technologies for research oversight to ensure the protection of human subjects taking part in research worldwide. (shrink)

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re‐emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which (...) Few or No Medical Counter‐Measures Exist (GPP‐EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP‐EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable. (shrink)

There is increasing interest in the need to address the ethical dilemmas related to the engagement of adolescents in sexual and reproductive health research. Research projects, including those that address issues related to STIs and HIV, adverse pregnancy outcomes, violence, and mental health, must be designed and implemented to address the needs of adolescents. Decisions on when an individual has adequate capacity to give consent for research most commonly use age as a surrogate rather than directly assessing capacity to understand (...) the issues and make an informed decision on whether to participate in research or not. There is a perception that adolescents participating in research are more likely to be coerced and may therefore not fully comprehend the risk they may be taking when engaging in research. This paper examines the various ethical issues that may impact stakeholders' decision making when considering engaging adolescents in SRH research in Nigeria. It makes a case for lowering the age of consent for adolescents. While some experts believe it is possible to extrapolate relevant information from adult research, studies on ethical aspects of adolescents' participation in research are still needed, especially in the field of sexual and reproductive health where there are often differences in knowledge, attitudes and practices compared to adults. The particular challenges of applying the fundamental principles of research ethics to adolescent research, especially research about sex and sexuality, will only become clear if more studies are conducted. (shrink)

BackgroundThe global interest in developing therapies for Ebola infection management and its prevention is laudable. However the plan to conduct an emergency immunization program specifically for healthcare workers using experimental vaccines raises some ethical concerns. This paper shares perspectives on these concerns and suggests how some of them may best be addressed.DiscussionThe recruitment of healthcare workers for Ebola vaccine research has challenges. It could result in coercion of initially dissenting healthcare workers to assist in the management of EVD infected persons (...) due to mistaken beliefs that the vaccine offers protection. It could also affect equity and justice. For example, where people who are not skilled health care professionals but who provide care to patients infected with Ebola are not prioritized for vaccination. The possibility of study participants contracting Ebola infection despite the use of experimental vaccine, and the standard of care they would receive, needs to be addressed clearly, transparently and formalized as part of the ethics review process. Future access to study products in view of current status of the TRIPS agreement needs to be addressed. Finally, broad stakeholder engagement at local, regional and international levels needs to be promoted using available communication channels to engage local, regional and international support. These same concerns are applicable for current and future epidemics.SummarySuccessful Ebola vaccine development research requires concerted efforts at public dialogue to address misconceptions, equity and justice in participant selection, and honest discussions about risks, benefits and future access. Public dialogue about Ebola vaccine research plans is crucial and should be conducted by trusted locals and negotiated between communities, researchers and ethics committees in research study sites. (shrink)

This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the (...) training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

HIV prevention is a critical health issue in Nigeria; a country that has one of the worst HIV epidemic profiles in the world. With 270,000 new infections in 2012, Nigeria is a prime site for HIV prevention research. One effect of the HIV epidemic has been to revolutionalise ethical norms for the conduct of research: it is now considered unethical to design and implement HIV related studies without community engagement. Unfortunately, there is very little commensurate effort in building the capacity (...) of local persons to engage actively with researchers, and there is no existing platform to facilitate dialogue between researchers and communities engaged in research in Nigeria. In an effort to address this gap, we undertook a series of three community dialogues and two community-researcher interface meetings in Nigeria. This paper aims to give an empirical account of the dialogue from these community engagement processes and provide a resulting critique of the implementation of research ethics practices in Nigeria. It is anticipated that the outputs will: support researchers in designing community-based research protocols; inform ethics committees of key considerations during research protocol reviews from a community perspective; and inform policy makers and research sponsors about issues of primary concern to communities with respect to HIV research. (shrink)

This paper describes a three‐year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross‐section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research.Following the training, (...) technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. (shrink)

ABSTRACT The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; and post‐trial access (...) to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement. (shrink)

Dental caries is the main oral health challenge for children in Nigeria. Concern about its negative impact makes screening for caries in children an attractive public health strategy. The ability to detect the preclinical phase of caries, the availability of screening tools with high accuracy, and the possibility of treatment before onset of clinical symptoms with significant cost and health benefits, makes it appropriate for screening. However in Nigeria, the poor availability of highly specific and sensitive screening tools, poor access (...) to oral health care and concerns with pre-screening consent, raise the question of the appropriateness of conducting screening programmes for children. We argue that a number of structural challenges associated with poor uptake of oral health care services need to be addressed before screening for caries can be considered ethically appropriate. These include facilitating access of children to quality oral health care and a systematic national approach to oral health impl... (shrink)

The successful demonstration that antiretroviral (ARV) drugs can be used in diverse ways to reduce HIV acquisition or transmission risks – either taken as pre-exposure prophylaxis (PrEP) by those who are uninfected or as early treatment for prevention (T4P) by those living with HIV – expands the armamentarium of existing HIV prevention tools. These findings have implications for the design of future HIV prevention research trials. With the advent of multiple effective HIV prevention tools, discussions about the ethics and the (...) feasibility of future HIV prevention trial designs have intensified. This article outlines arguments concerning the inclusion of newly established ARV-based HIV prevention interventions as standard of prevention in HIV prevention trials from multiple perspectives. Ultimately, there is a clear need to incorporate stakeholders in a robust discussion to determine the appropriate trial design for each study population. (shrink)

In their recent paper‘Undue inducement: a case study in CAPRISA 008’, Mngadi et al conclude that a participant in an HIV prevention study who deliberately concealed her pregnancy was not ‘unduly induced’ to participate by the offer of an experimental product. This paper argues that while the authors’ conclusion is sound, the framing of this case study is consistent with the preoccupation in research ethics with the concept of undue inducement, coupled with a highly risk-averse attitude to pregnancy. We suggest (...) that the critical research ethics question raised by Mngadi et al ’s case study is not ‘undue inducement’, but the exclusion of pregnant women from research studies where the risks are acceptable to the potential participant, and benefits likely. We also suggest that current regulatory paradigms regarding pregnancy are both overly paternalistic and value the fetus over the mother. In order to ensure timely provision of new HIV prevention agents, we argue that there is a need for expeditious testing of proven effective agents in pregnancy, with due consideration given to situations where preliminary efficacy data exist but fall short of licensure standards. This requires a paradigm shift from researchers, funders, regulators and ethical review bodies towards practices that critically examine the legitimacy of the exclusion of pregnant women on a study-by-study basis. (shrink)

BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure (...) research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.DiscussionDespite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).ConclusionHIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time. (shrink)

While most business ethics texts focus exclusively on individual decision making--what should an individual do--this resource presents the whole business ethics story. Highly realistic, readable, and down-to-earth, it moves from the individual to the managerial to the organizational level, focusing on business ethics in an organizational context to promote an understanding of complex influences on behavior. The new Fifth Edition is the perfect text for students entering the workplace, those seeking to become professionals in training, communications, compliance, in addition to (...) chief ethics officers, corporate counsel, heads of human resources, and senior executives. (shrink)

Providing a vibrant four-color design, market-leading BUSINESS ETHICS: ETHICAL DECISION MAKING AND CASES, Ninth Edition, thoroughly covers the complex environment in which managers confront ethical decision making. Using a proven managerial framework, this accessible, applied text addresses the overall concepts, processes, and best practices associated with successful business ethics programs--helping readers see how ethics can be integrated into key strategic business decisions. Thoroughly revised, the new ninth edition incorporates coverage of new legislation affecting business ethics, the most up-to-date examples, and (...) the best practices of high-profile organizations. It also includes 20 all-new or updated original case studies. (shrink)

The Language Dynamic identifies a number of mechanisms that enable the meaning potential of language from the phoneme through grammar and discourse and onto ideological systems. This book, which underpins functional theories of language with concepts from biological and cultural evolution, social semiotics and systems theory, is relevant to all who are interested in how and why we can mean and what it means for us as humans to be semiotic agents.

This volume is a collection of 16 essays, old and new, relating history and exegesis in the writings of Bede and Adomnán, and in the lives of Thomas Becket. The first part consists of seven studies of Bede's writings, notably his biblical commentaries and his Ecclesiastical History. Two of the essays are published here for the first time. The five studies in the second part, devoted to Adomnán, discuss his life of Saint Columba (the Vita Columbae) and his guide to (...) the Holy Places (De locis sanctis). One essay ('The Bible as Map'), published posthumously, compares his presentation of a major theme, the earthly and heavenly Jerusalem, with the approach adopted by Bede. The third section consists of two essays on the lives of Thomas Becket that were composed shortly after his death. They examine, in the context of patristic exegesis, the biblical images invoked in the texts in order to show how the saint's biographers understood the complex relationship between hagiography and history. With the exception of the Jarrow Lecture on Bede and the essays on Becket, the studies in both parts were published originally in edited books, some of them now hard to come by. (shrink)

A fairly long (~15,000 word) overview of ancient theories of freedom and determinism. It covers the supposed threat of causal determinism to "free will," i.e., the sort of control we need to have in order to be rightly held responsible for our actions. But it also discusses fatalistic arguments that proceed from the Principle of Bivalence, what responsibility we have for our own characters, and god and fate. Philosophers discussed include Aristotle, Epicurus, the Stoics, Carneades, Alexander of Aphrodisias, and Plotinus. (...) Plato is mentioned in passing a few times in connection with other philosophers. (shrink)

ABSTRACT Wilfrid Sellars argued that Kant’s account of the conceptual structures involved in experience can be given a linguistic turn so as to provide an analytic account of the resources a language must have in order to be the bearer of empirical knowledge. In this paper I examine the methodological aspects of Kant’s transcendental philosophy that Sellars took to be fundamental to influential themes in his own philosophy. My first aim here is to clarify and argue for the plausibility of (...) what I claim is Sellars’ interpretation of Kant’s ‘analytic’ transcendental method in the first Critique, based ultimately on non-trivial analytic truths concerning the concept of an object of our possible experience. Kant’s ‘transcendental proofs’ thereby avoid a certain methodological trilemma confronting the candidate premises of any such proof, taken from Sellars’ 1970s undergraduate exam question on Kant. In part II of the essay I conclude by highlighting in general terms how Kant’s method, as interpreted in the analytic manner explained in part I, was adapted by Sellars to produce some of the more influential aspects of his own philosophy, expressed in terms of what he contends is their sustainable reformulation in light of the so-called linguistic turn in twentieth-century philosophy. (shrink)

'Two things', wrote Kant, 'fill the mind with ever new and increasing admiration and awe: the starry heavens above and the moral law within'. Many would argue that since Kant's day, the study of the starry heavens has advanced while ethics has stagnated, and in particular that Kant's ethics offers an empty formalism that tells us nothing about how we should live. In Acting on Principle Onora O'Neill shows that Kantian ethics has practical as well as philosophical importance. First published (...) in 1975, the book is regarded as a classic account and defence of the Kantian ethical position. It addresses Kant's account of reasoning about action, in particular his controversial claim that the Categorical Imperative guides action and is basic to ethics and justice. This second edition offers a substantial new introduction and updated bibliography, and will be valuable for a wide readership in Kant studies and those studying ethics. (shrink)

Abstract: This paper traces a Kantian and pragmatist line of thinking that connects the ideas of conceptual content, object cognition, and modal constraints in the form of counterfactual sustaining causal laws. It is an idea that extends from Kant’s Critique of Pure Reason through C. I. Lewis’s Mind and the World-Order to the Kantian naturalism of Wilfrid Sellars and the analytic pragmatism of Robert Brandom. Kant put forward what I characterize as a modal conception of objectivity, which he developed as (...) an extended argument stretching from the transcendental deduction through the analogies of experience to the regulative maxims of reason and reflective judgment. In related ways in Lewis and Sellars, the very idea of an object of knowledge (and of intentionality more generally) is connected with a certain lawfulness or modal constraint the necessary representation of which, they argue, is an achievement of conceptualization. While Sellars agreed with the spirit of Lewis’s famous pragmatic conception of the a priori, Sellars’s conception of meaning and conceptual content differed in crucial ways with important consequences for this issue. I argue furthermore that a certain phenomenalist temptation threatens to spoil this insight both among some of Kant’s interpreters and in Lewis’s thought. Finally, I point out that Brandom’s “Kant-Sellars thesis” provides new support for this line of thought. Although questions concerning idealism continue to raise controversies for neo-Kantians and pragmatists, the line of thought itself represents a distinctive and still promising approach to questions concerning intentionality and conceptual content. (shrink)

A globe-spanning investigation into the Transhumanist movement, considering the tech billionaires, scientific luminaries, and DIY body-hackers attempting to prolong, improve, and ultimately transcend the limits of human life.

'Two things', wrote Kant, 'fill the mind with ever new and increasing admiration and awe: the starry heavens above and the moral law within'. Many would argue that since Kant's day, the study of the starry heavens has advanced while ethics has stagnated, and in particular that Kant's ethics offers an empty formalism that tells us nothing about how we should live. In Acting on Principle Onora O'Neill shows that Kantian ethics has practical as well as philosophical importance. First published (...) in 1975, the book is regarded as a classic account and defence of the Kantian ethical position. It addresses Kant's account of reasoning about action, in particular his controversial claim that the Categorical Imperative guides action and is basic to ethics and justice. This second edition offers a substantial new introduction and updated bibliography, and will be valuable for a wide readership in Kant studies and those studying ethics. (shrink)

Over the course of the past twenty-five years, feminist theory has had a forceful impact upon the history of Western philosophy. The present collection of essays has as its primary aim to evaluate past women’s published philosophical work, and to introduce readers to newly recovered female figures; the collection will also make contributions to the history of the philosophy of gender, and to the history of feminist social and political philosophy, insofar as the collection will discuss women’s views on these (...) issues. The volume contains contributions by an international group of leading historians of philosophy and political thought, whose scholarship represents some of the very best work being done in North and Central America, Canada, Europe and Australia. (shrink)

This chapter provides an outline of consent in the history of medical ethics. In doing so, it ranges over attitudes towards consent in medicine in ancient Greece, medieval Europe and the Middle East, as well as the history of Western law and medical ethics from the early modern period onwards. It considers the relationship between consent and both the disclosure of information to patients and the need to indemnify physicians, while attempting to avoid an anachronistic projection of concern with patient (...) autonomy too far back into the historical record. The chapter also includes a survey of the development of the social and intellectual infrastructure that underpins modern medical consent. It concludes with a brief discussion of possible future directions for ethical approaches to medical consent and competence that would depart from the models that arose in the twentieth-century. (shrink)

According to the “standard framing” of racial appeals in political speech, politicians generally rely on coded language to communicate racial messages. Yet recent years have demonstrated that politicians often express quite explicit forms of racism in mainstream political discourse. The standard framing can explain neither why these appeals work politically nor how they work semantically. This paper moves beyond the standard framing, focusing on the politics and semantics of one type of explicit appeal, candid racial communication. The linguistic vehicles of (...) CRC are neither true code words, nor slurs, but a conventionally defined class of “racialized terms.”. (shrink)