COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such (...) evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)

BackgroundRapid data sharing can maximize the utility of data. In epidemics and pandemics like Zika, Ebola, and COVID-19, the case for such practices seems especially urgent and warranted. Yet rapidly sharing data widely has previously generated significant concerns related to equity. The continued lack of understanding and guidance on equitable data sharing raises the following questions: Should data sharing in epidemics and pandemics primarily advance utility, or should it advance equity as well? If so, what norms comprise equitable data sharing (...) in epidemics and pandemics? Do these norms address the equity-related concerns raised by researchers, data providers, and other stakeholders? What tensions must be balanced between equity and other values?MethodsTo explore these questions, we undertook a systematic scoping review of the literature on data sharing in epidemics and pandemics and thematically analyzed identified literature for its discussion of ethical values, norms, concerns, and tensions, with a particular emphasis on equity. We wanted to both understand how equity in data sharing is being conceptualized and draw out other important values and norms for data sharing in epidemics and pandemics.ResultsWe found that values of utility, equity, solidarity, and reciprocity were described, and we report their associated norms, including researcher recognition; rapid, real-time sharing; capacity development; and fair benefits to data generators, data providers, and source countries. The value of utility and its associated norms were discussed substantially more than others. Tensions between utility norms and equity norms were raised.ConclusionsThis study found support for equity being advanced by data sharing in epidemics and pandemics. However, norms for equitable data sharing in epidemics and pandemics require further development, particularly in relation to power sharing and participatory approaches prioritizing inclusion. Addressing structural inequities in the wider global health landscape is also needed to achieve equitable data sharing in epidemics and pandemics. (shrink)

The American Journal of Bioethics, Volume 11, Issue 8, Page 27-29, August 2011.

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We adapted (...) a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

BackgroundGenome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.DiscussionWe explore ethical (...) issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.SummaryMany ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects. (shrink)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

In recent years, there has been an increase in the establishment of biobanks for genetic and genomic studies around the globe. One example of this is the Human Heredity and Health in Africa Initiative (H3Africa), which has established biobanks in the sub‐region to facilitate future indigenous genomic studies. The concept of ‘broad consent’ has been proposed as a mechanism to enable potential research participants in biobanks to give permission for their samples to be used in future research studies. However, questions (...) remain about the acceptability of this model of consent. Drawing on findings from empirical research about the role of trust in decision‐making, we argue that an account of entrustment may be an appropriate way of addressing current challenges of seeking consent for biobank research in Africa. We propose a set of key points to consider that can support the proposed entrustment framework. (shrink)

This casebook offers a window into important aspects of the ethical landscapes that researchers, communities, health professionals, policy makers – and ethicists – had to navigate during the first 15 months of the COVID-19 pandemic. The cases presented in this casebook are inevitably a selection informed by and constrained by the processes through which they were sought, and by the pandemic itself. Additional cases could valuably complement all the thematic chapters in this casebook. In addition, this casebook calls for a (...) broader approach to research ethics, both in terms of the issues to be considered, and the range of stakeholders having ethical responsibilities relating to the conduct of research. However a broad range of stakeholders have differing values, remits, authorities and capacities to exercise power in pandemic contexts, and in many situations, exercises of power, and their impact on research, are not direct and explicit. As such they are less amenable to clear representation in real-world cases, highlighting the importance of complementing discussions of the cases in this casebook with conceptual literature. Reflection on the research that has not been conducted is also critical. The COVID-19 pandemic has reemphasized that global health emergencies are never only about health. The wide-ranging impacts of the pandemic on economies, employment, education and a range of socially and culturally important activities, accentuates the importance of an equally comprehensive research agenda, which goes beyond a narrow conception of ‘health’, and addresses a broad range of pandemic impacts on populations. A further way in which we believe debate on pandemic research ethics both could and should be broadened is in relation to aspects of pandemic science beyond those relating to ‘response’. Inevitably, in the context of an emerging and continuing pandemic, scientific research attention has tended to focus on interventions that can enable more effective responses. However pandemic science can be thought of as divisible into four interdependent and overlapping domains: prevention, preparedness, response, and recovery. Research is essential to the development, evaluation, and deployment of interventions in each of these domains and effective, valuable, trustworthy and trusted research will require ethical questions to be identified and addressed. This chapter concludes by inviting the connection of additional cases and conceptual resources to this casebook, to enhance and expand the themes and topics covered. (shrink)

BackgroundObtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. (...) It aimed to inform best practices in recruiting participants into genomic research.MethodsA qualitative rapid ethical assessment was undertaken. Fifty-five semi-structured interviews were conducted with the parents of research participants. An additional nine semi-structured interviews were conducted with senior research scientists, research assistants and with a member of an ethics committee. A focus group with five parents of research participants and direct observations of four consent processes were also conducted. French and translated English transcripts were descriptively and thematically coded using OpenCode software.ResultsParticipants’ parents in the MalariaGEN study had differing understandings of the causes of malaria, the rationale for collecting blood samples, the purposes of the study and the kinds of information the study would generate. Genomic aspects of the research, including the gene/environment interaction underlying susceptibility or resistance to severe malaria, proved particularly challenging to explain and understand.ConclusionsThis study identifies a number of areas to be addressed in the design of consent processes for genomic research, some of which require careful ethical analysis. These include determining how much information should be provided about differing aspects of the research and how best to promote understandings of genomic research. We conclude that it is important to build capacity in the design and conduct of effective and appropriate consent processes for genomic research in low and middle-income settings. Additionally, consideration should be given to the role of review committees and community consultation activities in protecting the interests of participants in genomic research. (shrink)

The COVID-19 pandemic has both highlighted and exacerbated global health inequities, leading for calls for responses to COVID to promote social justice and ensure that no one is left behind. One key lesson to be learnt from the pandemic is the critical importance of decolonizing global health and global health research so that African countries are better placed to address pandemic challenges in contextually relevant ways. This paper argues that to be successful, programmes of decolonization in complex global health landscapes (...) require a complex three-dimensional approach. Drawing on the broader discourse of political decolonization that has been going on in the African context for over a century, we present a model for unpacking the complex task of decolonization. Our approach suggests a three-dimensional approach which encompasses hegemomic; epistemic; and commitmental elements. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics is necessary to effectively (...) address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

Integrated information systems are increasingly used in schools, and the advent of the technology-rich classroom requires a new degree of ongoing classroom assessment. Able to track web searches, resources used, task completion time, and a variety of other classroom behaviors, technology-rich classrooms offer a wealth of potential information about teaching and learning. This information can be used to track student progress in languages, STEM, and in 21st Century skills, for instance. However, despite these changes, there has been little change in (...) the kind of data made available to teachers, administrators, students, and parents. Measuring and Visualizing Learning in the Information-Rich Classroom collects research on the implementation of classroom assessment techniques in technology-enhanced learning environments. Building on research conducted by a multinational and multidisciplinary team of learning technology experts, and specialists from around the globe, this book addresses these discrepancies. With contributions from major researchers in education technology, testing and assessment, and education psychology, this book contributes to a holistic approach for building the information infrastructure of the 21st Century school. (shrink)

Background: Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods: The study used a rapid assessment incorporating multiple qualitative methods (...) including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results: MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions: It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. (shrink)

This paper questions an exclusively state-centred framing of global health justice and proposes a multilateral alternative. Using the distribution of COVID-19 vaccines to illustrate, we bring to light a broad range of global actors up and down the chain of vaccine development who contribute to global vaccine inequities. Section 1 (Background) presents an overview of moments in which diverse global actors, each with their own priorities and aims, shaped subsequent vaccine distribution. Section 2 (Collective action failures) characterises collective action failures (...) at each phase of vaccine development that contributed to global vaccine disparities. It identifies as critical the task of establishing upstream strategies to coordinate collective action at multiple stages across a range of actors. Section 3 (A Multilateral model of global health governance) takes up this task, identifying a convergence of interests among a range of stakeholders and proposing ways to realise them. Appealing to a responsibility to protect (R2P), a doctrine developed in response to human rights atrocities during the 1990s, we show how to operationalise R2P through a principle of subsidiarity and present ethical arguments in support of this approach. (shrink)

Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines recommend that parents or another proxy provide legal consent for children to participate, but that children should be involved in the decision through providing assent. However, there remain uncertainties about how to judge when children are ready to give assent and about appropriate assent processes. Malawi does not yet have detailed guidelines (...) on assent. Understanding perspectives among children and their parents can assist in developing contextually-appropriate assent guidance. Qualitative research was conducted with children and parents in three settings in Southern Malawi, to take account of any variations between socioeconomic and cultural contexts. In each setting, interviews were conducted with parents and their children who had participated in paediatric research to understand their experiences of assent and views on appropriate assent practice. Focus groups were also conducted with children and parents, to understand broader social perspectives. We found widespread support for involving children in decisions on research participation. Participants identified a range of factors that affect children’s capacity to give assent, including intellectual capacity, emotional development, life experience and cultural norms. Age was often mentioned as a consideration, but deemed an unreliable sole indicator of capacity to assent. In relation to appropriate assent processes, participants emphasised considerations such as supporting effective understanding and minimizing harms. Views on how to achieve these aims varied; for example, there were different ideas about the appropriate order in which to approach children and parents, and about whose decision to respect in the event of disagreement. Parents and children agreed about the value of involving children in decisions on research, and about the need to promote children’s decision-making capacity while respecting parents’ interests in children’s welfare. Developing practical guidance that meets these principles is challenging, particularly given the need for flexible approaches that suit different study types, children’s capacities and family environments. Further discussion within the Malawi research and ethics community will help develop contextually-appropriate guidelines. (shrink)

Biometrics is the science of establishing the identity of an individual based on their physical attributes. Ethical concerns surrounding the appropriate use of biometrics have been raised, especial...

Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and (...) study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: words and regulation; reimbursement, suspicions, and joining; and responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust. (shrink)

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data (...) to support drug registration applications. We also encountered significant resource constraints which required the development of appropriate human resources and infrastructure. We suggest a research agenda to promote responsible and equitable data sharing while safeguarding the rights and interests of research participants and researchers. (shrink)

For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics (...) committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices. (shrink)

Antimicrobial resistance (AMR) poses an increasing threat to patient care and population health and there is a growing need for novel therapies to tackle AMR. Bacteriophage (phage) therapy is a re-emerging antimicrobial strategy with the potential to transform how bacterial infections are treated in patients and populations. Currently, in the UK, phages can be used as unlicensed medicinal products on a ‘named-patient’ basis. We make an ethical case for why it is crucially important for the UK to invest in Good (...) Manufacturing Practice (GMP) for both ongoing unlicensed and future licensed phage therapy. Access to phages produced to GMP (GMP phages) will ensure effective patient care and better outcomes as well as health systems benefits. The UK also has the potential to become a global leader in the timely and cost-efficient manufacturing and supply of a therapy that meets internationally recognised standards. (shrink)

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in (...) Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)

My strategy is to examine a recent trend in philosophical discussions of responsibility, a trend that tries, but I think ultimately fails, to give an acceptable analysis of the conditions of responsibility. It fails due to what at first appear to be deep and irresolvable metaphysical problems. It is here that I suggest that the condition of sanity comes to the rescue. What at first appears to be an impossible requirement for responsibility---the requirement that the responsible agent have created her- (...) or himself---turns out to be the vastly more mundane and non controversial requirement that the responsible agent must, in a fairly standard sense, be sane. (shrink)

Introduction -- Part 1. The nature of order in world politics: the concept of order in world politics; does order exist in world politics?; how is order maintained in world politics?; order versus justice in world politics -- Part 2. Order in the contemporary international system: the balance of power and international order; international law and international order; diplomacy and international order; war and international order; the great powers and international order -- Part 3. Alternative paths to world order: alternatives (...) to the contemporary states system; the decline of the states system; the obsolescence of the states system; the reform of the states system; conclusion. (shrink)

Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...

Background Dynamic consent has been proposed as a process through which participants and patients can gain more control over how their data and samples, donated for biomedical research, are used, resulting in greater trust in researchers. It is also a way to respond to evolving data protection frameworks and new legislation. Others argue that the broad consent currently used in biobank research is ethically robust. Little empirical research with cohort study participants has been published. This research investigated the participants’ opinions (...) of adding a dynamic consent interface to their existing study. Methods Adult participants in the Extended Cohort for E-health, Environment and DNA longitudinal cohort study who are members of the EXCEED Public and Participant Engagement Group were recruited. Four focus groups were conducted and analysed for thematic content. Discussion topics were derived from a review of the current literature on dynamic consent. Results Participants were in favour of many aspects of a dynamic consent interface, such as being able to update their information, add additional data to their records and choose withdrawal options. They were supportive provided it was simple to use and not intrusive. Participants expressed a markedly high level of trust in the study and its investigators and were unanimously happy with their current participation. No strong support was found for adding a dynamic consent interface to EXCEED. Conclusions Trust in the study researchers was the strongest theme found. Openness and good data security were needed to retain their trust. While happy to discuss dynamic consent, participants were satisfied with the current study arrangements. There were indications that changing the study might unnecessarily disturb their trust. This raised the question of whether there are contexts where dynamic consent is more appropriate than others. This study was limited by the small number of participants who were committed to the study and biased towards it. More research is needed to fully understand the potential impact of adding a dynamic consent interface to an existing cohort study. (shrink)

The legal environment -- Regulation of nursing practice -- Nurses in legal actions -- Standards of care -- Defenses to negligence or malpractice -- Prevention of malpractice -- Nurses as witnesses -- Professional liability insurance -- Accepting or refusing an assignment/patient abandonment -- Delegation to unlicensed assistive personnel -- Patients' rights and responsibilities -- Confidential communication -- Competency and guardianship -- Informed consent -- Refusal of treatment -- Pain control -- Patient teaching and health counseling -- Medication administration -- Clients (...) with AIDS and HIV testing -- Abusive situations -- Reproductive services -- Restraints -- Emergency psychiatric admissions -- Organ and tissue donation and transplantation -- Discharge against medical advice -- The medical record and documentation standards -- Electronic health information and communications -- Interdependent nursing functions: verbal orders and telenursing -- Event reporting and compliance -- Quality and safety in nursing practice -- Forensic issues -- Employer and employee rights -- Contracts -- Corporate liability -- Employment contracts and unionization -- Employment status liability -- Staffing issues and floating -- Americans with Disabilities Act -- Employees with AIDS/HIV infection and exposure to bloodborne pathogens -- Impaired nurses -- Sexual harassment in the workplace -- Violence in the workplace -- Intentional torts -- Environmental health and safety -- Ethical decision making -- Professional boundaries and patient relationships -- Moral courage and patient advocacy -- Social media and online professionalism -- Reporting illegal, unethical, or unsafe conduct -- Maternal versus fetal rights -- Futility of care -- Advance directives and end-of-life decisions -- Assisted suicide. (shrink)

Only human beings have a rich conceptual repertoire with concepts like tort, entropy, Abelian group, mannerism, icon and deconstruction. How have humans constructed these concepts? And once they have been constructed by adults, how do children acquire them? While primarily focusing on the second question, in The Origin of Concepts , Susan Carey shows that the answers to both overlap substantially. Carey begins by characterizing the innate starting point for conceptual development, namely systems of core cognition. Representations of core (...) cognition are the output of dedicated input analyzers, as with perceptual representations, but these core representations differ from perceptual representations in having more abstract contents and richer functional roles. Carey argues that the key to understanding cognitive development lies in recognizing conceptual discontinuities in which new representational systems emerge that have more expressive power than core cognition and are also incommensurate with core cognition and other earlier representational systems. Finally, Carey fleshes out Quinian bootstrapping, a learning mechanism that has been repeatedly sketched in the literature on the history and philosophy of science. She demonstrates that Quinian bootstrapping is a major mechanism in the construction of new representational resources over the course of childrens cognitive development. Carey shows how developmental cognitive science resolves aspects of long-standing philosophical debates about the existence, nature, content, and format of innate knowledge. She also shows that understanding the processes of conceptual development in children illuminates the historical process by which concepts are constructed, and transforms the way we think about philosophical problems about the nature of concepts and the relations between language and thought. (shrink)

Background:Less sedated and more awake patients in the intensive care unit may cause ethical challenges.Research objectives:The purpose of this study is to describe ethical challenges registered nurses experience when patients refuse care and treatment.Research design:Narrative individual open interviews were conducted, and data were analysed using a phenomenological hermeneutic method developed for researching life experiences.Participants and research context:Three intensive care registered nurses from an intensive care unit at a university hospital in Norway were included.Ethical considerations:Norwegian Social Science Data Services approved the (...) study. Permission was obtained from the intensive care unit leader. The participants’ informed and voluntary consent was obtained in writing.Findings:Registered nurses experienced ethical challenges in the balance between situations of deciding on behalf of the patient, persuading the patient and letting the patient decide. Ethical challenges were related to patients being harmful to themselves, not keeping up personal hygiene and care or hindering critical treatment.Discussion:It is made apparent how professional ethics may be threatened by more pragmatic arguments. In recent years, registered nurses are faced with increasing ethical challenges to do no harm and maintain dignity.Conclusion:Ethically challenging situations are emerging, due to new targets including conscious and aware critical care patients, leaving an altered responsibility on the registered nurses. Reflection is required to adjust the course when personal and professional ideals no longer are in harmony with the reality in the clinical practice. RNs must maintain a strong integrity as authentic human beings to provide holistic nursing care. (shrink)

In this important book, Susan Hurley sheds new light on consciousness by examining its relationships to action from various angles. She assesses the role of agency in the unity of a conscious perspective, and argues that perception and action are more deeply interdependent than we usually assume. A standard view conceives perception as input from world to mind and action as output from mind to world, with the serious business of thought in between. Hurley criticizes this picture, and considers (...) how the interdependence of perceptual experience and agency at the personal level (of mental contents and norms) may emerge from the subpersonal level (of underlying causal processes and complex dynamic feedback systems). Her two-level view has wide implications, for topics that include self-consciousness, the modularity of mind, and the relations of mind to world. The self no longer lurks hidden somewhere between perceptual input and behavioral output, but reappears out in the open, embodied and embedded in its environment. Hurley traces these themes from Kantian and Wittgensteinian arguments through to intriguing recent work in neuropsychology and in dynamic systems approaches to the mind, providing a bridge from mainstream philosophy to work in other disciplines. Consciousness in Action is unique in the range of philosophical and scientific work it draws on, and in the deep criticism it offers of centuries-old habits of thought. (shrink)

The nature/nurture debate is not dead. Dichotomous views of development still underlie many fundamental debates in the biological and social sciences. Developmental systems theory offers a new conceptual framework with which to resolve such debates. DST views ontogeny as contingent cycles of interaction among a varied set of developmental resources, no one of which controls the process. These factors include DNA, cellular and organismic structure, and social and ecological interactions. DST has excited interest from a wide range of researchers, from (...) molecular biologists to anthropologists, because of its ability to integrate evolutionary theory and other disciplines without falling into traditional oppositions. The book provides historical background to DST, recent theoretical findings on the mechanisms of heredity, applications of the DST framework to behavioral development, implications of DST for the philosophy of biology, and critical reactions to DST. (shrink)

It is well-known that Chatton is among the earliest and most vehement critics of Ockham’s theory of judgment, but scholars have overlooked the role Chatton’s criticisms play in shaping Ockham’s final account. In this paper, I demonstrate that Ockham’s most mature treatment of judgment not only contains revisions that resolve the problems Chatton identifies in his earlier theories, but also that these revisions ultimately bring his final account of the objects of judgment surprisingly close to Chatton’s own. Even so, I (...) argue that, at the end of the day, there remain significant differences between their respective analyses of the structure and intentionality of judicative states. (shrink)