Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are (...) responsible for considering the arrangements. There are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs (...) are not always justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (shrink)

Objective: This main aim of the study is to explore COVID-19 pandemic problems from the perspective of public health-clinical care ethics through online mediareports in Turkey. Method: This research was designed as a descriptive and qualitative study that assesses COVID-19 through online media reports on critics between the periods of March 11, 2020 and April 2 2020 as a quantitative as number of reports and qualitative study, across Turkey. Reports were from Turkish Medical Association websites which included (...) newspaper reports. Study data were presented as statistically and qualitative data case and headlines. No ethical or ofTicial permission was sought as the study was conducted through open access internet news sites. Results: This online reports analysis retrieved about 6723 articles about the COVID-19. According to study data, information about COVID-19 were themed as follows: general deTiciencies in taking action and isolation, lack of isolation, passengers and transport vehicles not quarantined ; insufTicient diagnostic tests, decision to test after healthcare professionals become infected, lack of equipment, lack of evaluation outbreak countries [Table 2]. Conclusion and Suggestions: COVID-19 is a pandemic and is a global public health problem that concerns every individual and needs to be handled carefully. This requires a multi-faceted preparation and education. In this context, healthcare professionals should be well trained in this aspect and have all the necessary equipment throughout the process. Additionally, it should work systematically with the cooperation of all health organizations, the Ministry of Health, local governments and of course the media, in order to inform society, fairly distribute the resources and to implement the safety measures effectively. BrieTly, lack of transparency, insufTicient information, limited resources, lack of public health protection measures such as partial quarantine decision, partial implementation of the scientiTic board's re c ommenda ti on s fo r e c on omi c rea s on s, and contradiction of the explanations are revealed as serious ethical problems. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of (...) post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a (...) la atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (shrink)

The implementation of actions for health is only possible by adequate policy development. There is a need to review the nature and development of policy in health political science gaze. Therefore, the present study aims to conduct a review on theory and researches to develop adequate policies in health care system. It provides a comprehensive review about the important theories with empirical research evidences for promoting health. The review analysis shows that it is important (...) to understand the theory and approach behind policy development to recognize the incremental nature of aspects involved in policy development. The health political science insights need to be embraced in the light of public health and promotion of health. The present study has provided deep understanding about the structuring and implementation of health policies in health care systems in the light of theory and research. (shrink)

Several quantitative surveys have been conducted internationally to gather empirical information about physicians’ general attitudes towards health care rationing. Are physicians ready to accept and implement rationing, or are they rather reluctant? Do they prefer implicit bedside rationing that allows the physician–patient relationship broad leeway in individual decisions? Or do physicians prefer strategies that apply explicit criteria and rules?

This paper argues that societal duties of health promotion are underwritten (at least in large part) by a principle of beneficence. Further, this principle generates duties of justice that correlate with rights, not merely “imperfect” duties of charity or generosity. To support this argument, I draw on a useful distinction from bioethics and on a somewhat neglected approach to social obligation from political philosophy. The distinction is that between general and specific beneficence; and the approach from political philosophy has (...) at times been called equality of concern. After clarifying the distinction and setting out the basis of the equality of concern view, I argue that the result is a justice-based principle of “specific” beneficence that should be reflected in a society’s health policy. I then draw on this account to criticize, refine, and extend some prominent health care policy proposals from the bioethics literature. (shrink)

How can researchers use race, as they do now, to conduct health-care studies when its very definition is in question? The belief that race is a social construct without “biological authenticity” though widely shared across disciplines in social science is not subscribed to by traditional science. Yet with an interdisciplinary approach, the two horns of the social construct/genetics dilemma of race are not mutually exclusive. We can use traditional science to provide a rigorous framework and use a social-science (...) approach so that “invisible” factors are used to adjust the design of studies on an as-needed basis. One approach is to first observe health-care outcomes and then categorize the outcomes, thus removing genetic differences as racial proxies from the design of the study. From the outcomes, we can then determine if there is a pattern of conceivable racial categories. If needed, we can apply dynamic notions of race to acknowledge bias without prejudice. We can use them constructively to improve outcomes and reduce racial disparities. Another approach is nearly identical but considers race not at all: While analyzing outcomes, we can determine if there are biological differences significant enough to identify classifications of humans. That is, we look for genetic patterns in the outcomes and classify only those patterns. There is no attempt to link those patterns to race. (shrink)

El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas obligaciones son (...) los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores. [ABSTRACT] The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, (1) obligations of access to health care and (2) the obligations of access to information. The intended beneficiaries of these obligations are individual participants of research studies. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. Then I make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise the main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections. (shrink)

Imagine you are the CEO of a hospital [. . .]. Decisions are constantly being made in your organization about how to spend the organization's money. The amount of money available to spend is never adequate to pay for everything you wish you could spend it on, therefore you must set spending priorities. There are two questions you need to be able to answer . . . How should we set priorities in this organization? How do we know when we (...) are doing it well? When people seek to achieve good public policy, the result will tend to be good public policy. In a collective choice process, public‐spirited individual participants produce good public policy by deliberating—talking with each other, listening to each other's arguments, and being willing to learn and change their minds based on such dialogue. –Steven Kelman (1992: 181) Public policy scholars agree that those persons (or agencies) vested with the authority to establish health care priorities should elicit public input before making rationing decisions. The two most common approaches are (i) consultation and (ii) deliberation. Though deliberation has obvious advantages over consultation, it falters in the face of the objection that ordinary citizens lack the cognitive resources for the extended, rigorous inquiry required of them in undertaking the priority‐setting task. To overcome this objection, I propose that deliberative forums for health care rationing should be designed so that they imitate the natural pattern of human experience. The experience of deliberation should encompass both prolonged periods of less‐demanding cognitive activity, in which citizens passively receive information, and briefer periods of more‐demanding cognitive activity, in which they engage in active problem‐solving. In arguing for this thesis, I rely on two theoretical sources and one practical case study, in the following order: (i) John Dewey's metaphysics of experience, (ii) cognitive science research on schemas and frames, and (iii) the Health Care Council in São Paulo, Brazil. (shrink)

Ontologies are being ever more commonly used in biomedical informatics and we provide a survey of some of these uses, and of the relations between ontologies and other terminology resources. In order for ontologies to become truly useful, two objectives must be met. First, ways must be found for the transparent evaluation of ontologies. Second, existing ontologies need to be harmonised. We argue that one key foundation for both ontology evaluation and harmonisation is the adoption of a realist paradigm in (...) ontology development. For science-based ontologies of the sort which concern us in the eHealth arena, it is reality that provides the common benchmark against which ontologies can be evaluated and aligned within larger frameworks. Given the current multitude of ontologies in the biomedical domain the need for harmonisation is becoming ever more urgent. We describe one example of such harmonisation within the ACGT project, which draws on ontology-based computing as a basis for sharing clinical and laboratory data on cancer research. (shrink)

The study aimed to identify training for the performance of the medical staff and its role in developing the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. , and technicians) of 2150 employees, a stratified random sample of 330 employees was selected, the questionnaire was distributed to them, and 302 questionnaires were retrieved, with a rate of 91.5%. One of the most important results of the study was the existence of a statistically significant (...) effect of training on the development of health care quality. One of the most important recommendations of the study was to provide more suitable opportunities to create a climate for the professional growth of employees, and pay more attention to the expansion of programs and training courses that are in line with the requirements of administrative empowerment. (shrink)

The study aimed to identify training for the performance of the medical staff and its role in developing the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. , and technicians) of 2150 employees, a stratified random sample of 330 employees was selected, the questionnaire was distributed to them, and 302 questionnaires were retrieved, with a rate of 91.5%. One of the most important results of the study was the existence of a statistically significant (...) effect of training on the development of health care quality. One of the most important recommendations of the study was to provide more suitable opportunities to create a climate for the professional growth of employees, and pay more attention to the expansion of programs and training courses that are in line with the requirements of administrative empowerment. (shrink)

The study aimed to identify the delegation of authority for the performance of the medical staff and its relationship to improving the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. Administrators, and technicians) with a total of 2150 employees, and the questionnaire was distributed to a stratified random sample of 330 employees, and 302 questionnaires were retrieved, with a rate of 91.5%. One of the most important results of the study was the existence (...) of a statistically significant relationship between delegation of authority and the quality of health care. One of the most important recommendations of the study was to strengthen the direction of senior management towards excellence in patient service, because the patient represents a fundamental focus in health services. (shrink)

Breast cancer treatment is being transformed by artificial intelligence (AI). Nevertheless, most scientists, engineers, and physicians aren't ready to contribute to the healthcare AI revolution. In this paper, we discuss our experiences teaching a new American student undergraduate course that seeks to train the next generation for cross-cultural design thinking, which we believe is critical for AI to realize its full potential in breast cancer treatment. The main tasks of this course are preparing, performing and translating interviews with healthcare professionals (...) from both Portugal and the USA. Since the course is offered in Portugal as a short-term faculty-led study abroad program, students can explore the effect of culture on healthcare delivery and the design of healthcare technologies. The learning tests demonstrated student growth for breast cancer treatment in many areas important for the development of AI. In respect to understanding breast cancer care, most students had undervalued the effect of cancer and its treatment on the quality of life of women before taking this course and most were unaware of the importance of multidisciplinary care teams. Regarding AI in medical, students became more mindful of data privacy issues and the need to consider the effect of AI on healthcare professionals. (shrink)

The study aimed to identify the sharing of information and its impact on the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. The study adopted the descriptive analytical approach. The number is 2150 employees, and the questionnaire was distributed to a stratified random sample of 330 employees, and 302 questionnaires were retrieved, with a rate of 91.5%. One of the most important results of the study was that there is a statistically significant effect (...) at the level (α≤0.05) of information sharing for the performance of the medical staff in the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. The axis of participation in information came with a relative weight (69.6%) and a high degree. The level of health care quality was high with a relative weight of (69.0%). One of the most important recommendations of the study was the need to pay attention to measuring patients' satisfaction levels, and to set up a box for complaints and suggestions for patients, and what are their suggestions and point of view for the service provided to them. (shrink)

The study aimed to identify the delegation of authority for the performance of the medical staff and its relationship to improving the quality of health care in Al-Shifa Medical Complex in the southern Palestinian governorates. Administrators, and technicians) with a total of 2150 employees, and the questionnaire was distributed to a stratified random sample of 330 employees, and 302 questionnaires were retrieved, with a rate of 91.5%. One of the most important results of the study was the existence (...) of a statistically significant relationship between delegation of authority and the quality of health care. One of the most important recommendations of the study was to strengthen the direction of senior management towards excellence in patient service, because the patient represents a fundamental focus in health services. (shrink)

Aims and Objectives. This article uses the concept of embodiment to demonstrate a conceptual approach to applied phenomenology. -/- Background. Traditionally, qualitative researchers and healthcare professionals have been taught phenomenological methods, such as the epoché, reduction, or bracketing. These methods are typically construed as a way of avoiding biases so that one may attend to the phenomena in an open and unprejudiced way. However, it has also been argued that qualitative researchers and healthcare professionals can benefit from phenomenology’s well-articulated theoretical (...) framework, which consists of core concepts, such as selfhood, empathy, temporality, spatiality, affectivity, and embodiment. -/- Design. This is a discursive article that demonstrates a conceptual approach to applied phenomenology. -/- Method. To outline and explain this approach to applied phenomenology, the Discussion section walks the reader through four stages of phenomenology, which progress incrementally from the most theoretical to the most practical. -/- Discussion. Part one introduces the philosophical concept of embodiment, which can be applied broadly to any human subject. Part two shows how philosophically trained phenomenologists use the concept of embodiment to describe general features of illness and disability. Part three illustrates how the phenomenological concept of embodiment can inform empirical qualitative studies and reflects on the challenges of integrating philosophy and qualitative research. Part four turns to phenomenology’s application in clinical practice and outlines a workshop model that guides clinicians through the process of using phenomenological concepts to better understand patient experience. -/- Conclusion and Relevance to Clinical Practice. A conceptual approach to applied phenomenology provides a valuable alternative to traditional methodological approaches. Phenomenological concepts provide a foundation for better understanding patient experience in both qualitative health research and clinical practice, and therefore provide resources for enhancing patient care. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice entails a commitment (...) to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

The article discusses the actual problem of social support for people with mental health problems, which has an important place in the study field of social psychology and social work.The article also deals with the definition of the concept of “mental health”, the problem of introducing the term “mental health problems” as a way to avoid stigmatization, and the spread of a humanistic attitude to persons with a psychiatric diagnosis. It also discussed modern theoretical approaches that offer (...) an understanding of the contribution of biological, social, and psychological factors into the cause of mental health problems. -/- The problem of mental illness is common to all countries of the world, as WHO data evidenced the number of people with mental disorders among the world’s population, ranging from 4–5 %. According to researchers P. Voloshin and N. Maruta, the spread of mental and behavioral disorders in Ukraine is characterized by a slow increase of about 2.9 % in every 10 years. Researchers argue that in subsequent years, according to the prognostic data, there will be an increase in these indicators. The issue of providing social support to people with PDS in Ukrainian society is very relevant, which is complicated by their social isolation in the process of recovery after the treatment. The results of scientific research in the context of different cultures and relatively diverse life events (hospitalization, mental illness, unemployment, old age) generally confirm the positive results of using social support to promote mental and physical health. Instead, there are no studies in Ukrainian science related to the phenomenon of social support of people with mental health problems. -/- It is important to define the concepts of “mental health” and “mental health problems” in the process of studying the features of social support for people with mental health problems. The term “mental health” combines the medical and psychological fields of science and practice, but modern psychology offers a comprehensive approach to assessing the psychological health of a person, the psychological norm, its limits, taking into account the criteria of mental health. The description of the mental health given by the Psychological Dictionary points out the components of awareness and the sense of continuity, continuity and identity of their physical and mental “I”; sense of continuity and identity of experiences in similar situations; critical to yourself and your mental activity and its results; the adequacy of psychic reactions of force and frequency of environmental influences; the ability to manage their behavior in accordance with social norms; planning personal activities and implementing them; changing the way of behavior depending on the changing circumstances of life. -/- The concept of “mental health problem” was taken as a term that denotes all the symptoms classified in ICD-10 and DSM-IV, which are recommended by experts to clients for appropriate treatment and care. Scientists and mental health practitioners point out that mental health problems can affect the way an individual thinks, feels, and behaves; affects self-service, fulfills professional duties, social, family roles, and household behavior, which is usually deeply affected by the quality of life of the individual. Numerous results of the research show that there are specific psychological and personality factors apart from the biological causes of mental disorders (genetic factors that contribute to the imbalance of chemicals in the brain) that make people vulnerable to occurrences of the mental health problems. -/- Several modern theoretical approaches offer an understanding of the contribution of biological, social, and psychological factors to the induction of mental health problems: the traditional medical model, the rehabilitation model, the interface model, the social model, and the biopsychosocial approach. Only biopsychosocial and social models are consistent with the definition of WHO disability and emphasize the impact social aspects of mental health and the quality of life of people with mental health problems. -/- Individuals with PPP, as a social community, have specific needs that differentiate them from other members of society, one of which is the need for constant socio-psychological support. So, the contribution of psychology and social work to the quality of life of people with mental disorder lies in the application of professional approaches and methods based on the biopsychosocial (social) model, which emphasize the need for socio-psychological support. An example of such a technique is the model of modern social work practice “people-in-environment”, which serves as a guiding principle of social work and emphasizes the importance of understanding the persons with disorder and their behavior in the light of the multiple context of the social environment in which these persons live and act. Specialists of social work and psychology make interventions at three levels: individual, at the family level, and at the community level, by means of intensifying the support of the environment within the cognitive-behavioral and other approaches, which contribute to the process of reintegrating people with mental health problems into community. (shrink)

Philosophers of science have insisted that evidence of underlying mechanisms is required to support claims about the effects of medical interventions. Yet evidence about mechanisms does not feature on dominant evidence-based medicine “hierarchies.” After arguing that only inferences from mechanisms (“mechanistic reasoning”)—not mechanisms themselves—count as evidence, I argue for a middle ground. Mechanistic reasoning is not required to establish causation when we have high-quality controlled studies; moreover, mechanistic reasoning is more problematic than has been assumed. Yet where the problems (...) can be overcome, mechanistic reasoning can and should be used as evidence. (shrink)

ABSTRACT When patients refuse to receive medical treatment, the consequences of honouring their decisions can be tragic. This is no less true of patients who autonomously decide to refuse treatment. I distinguish three possible implications of these autonomous decisions. According to the Permissibility Claim, such a decision implies that it is permissible for the patient who has made the autonomous decision to forego medical treatment. According to the Anti‐Paternalism Claim, it follows that health‐care professionals are not morally permitted (...) to treat that patient. According to the Binding Claim it follows that these decisions are binding on health‐care professionals. My focus is the last claim. After arguing that it is importantly different from each of the first two claims, I give two arguments to show that it is false. One argument against the Binding Claim draws a comparison with cases in which patients autonomously choose perilous positive treatments. The other argument appeals to considered judgments about cases in which disincentives are used to deter patients from refusing sound treatments. (shrink)

¿Qué ocurre con la continuidad del tratamiento de los sujetos de investigación después de que realizan la última visita del ensayo en el que participan? En algunos casos, la falta de continuidad de atención de la salud apropiada podría poner en peligro la salud de estas personas. Por lo tanto, es probable que los sujetos de investigación que al terminar su participación en un ensayo todavía se encuentran enfermos, necesiten continuar con el tratamiento en estudio u otra atención de la (...) salud adecuada por el resto de sus vidas, sean unos pocos meses o muchos años. No obstante, no todas las sociedades cuentan con los recursos e instituciones para resolver el problema de la continuidad de tratamiento beneficioso. La opinión de un sujeto de investigación norteamericano, al que llamaremos Pedro, sin seguro de salud que participó en un ensayo de largo plazo sobre diabetes ejemplifica el problema de la continuidad de tratamiento beneficioso: “de repente [ellos] simplemente cortan la cuerda, y uno está solo por su cuenta, ya sabes. O consigues trescientos o cuatrocientos dólares al mes para seguir con esto o simplemente sigues adelante y mueres”. En este trabajo intentaré dar un panorama de la reciente discusión en torno al problema de la continuidad de tratamiento beneficioso en la ética de la investigación. Por tratamiento beneficioso hago referencia a dos cosas. En primer lugar, el tratamiento beneficioso puede ser (1) el tratamiento en estudio, p. e. el tratamiento o intervención en investigación que estaba recibiendo Pedro para su diabetes en el ejemplo anterior. Una droga o un producto biológico es un tratamiento en estudio para un uso propuesto (indicación) desde el primer ensayo con seres humanos hasta el momento en que es aprobado para su comercialización por las autoridades reguladoras de fármacos. El segundo lugar, el tratamiento beneficioso también puede ser (2) otra atención de la salud apropiada para el sujeto de investigación distinta del tratamiento en estudio, p. e. si existiera un tratamiento alternativo disponible para la enfermedad o condición de Pedro, distinto del tratamiento en estudio, y se justificara hacer la transición a ese otro tratamiento por razones de un mejor perfil de efectividad, seguridad y/o toxicidad. En la sección 1 de este trabajo introduciré una taxonomía de las obligaciones éticas de acceso posinvestigación (1.1.), realizaré un relevamiento histórico del concepto basado en las guías éticas internacionales (1.2) y analizaré el surgimiento del término “continuidad de tratamiento beneficioso hacia los sujetos de investigación” y otros términos análogos como “atención después de la investigación” (1.3). En la sección 2 presentaré los casos ejemplares en la bibliografía: continuidad de tratamiento en investigación en VIH/SIDA (2.1), continuidad de tratamiento en investigación en cáncer (2.2.) y otros casos de continuidad de tratamiento (2.3). (shrink)

The study investigated factors that influence the uptake of maternal healthcare services by women in Zimbabwe, using a logit model. Data from the Zimbabwe Demographic Health Survey (ZDHS, 2015) was used. Deteriorating maternal health indicators motivated the study. The effect of socio-economic and demographic factors on the probability of utilising maternal healthcare services was examined. Descriptive statistics and a logit model were used for data analysis. Results from the logit model show that region of residence, insurance cover, educational (...) level, employment status, maternal age, birth order, place of residence, number of living children, maternal age and household income all influence the utilisation of maternal healthcare services by women in Zimbabwe. Basing on research findings, the study recommends that relevant authorities make more available vocational training centres and education institutions since education was found to influence the uptake of maternal healthcare services. There is need to encourage family planning so as to reduce the number of children, especially among the apostolic sect, which affects the uptake of maternal healthcare. Compulsory national health insurance schemes could be adopted to mitigate the effect of low income that discourages the use of institutional facilities for delivery. The issue of balanced regional development needs to be pursued through accelerating devolution to ensure equal access to maternal healthcare facilities in all provinces. (shrink)

Розглянуто питання формування системи управління соціальною відповідаль-ністю закладу охорони здоров’я. Класифіковано теоретичні підходи до визначення поняття «соціальна відповідальність». Наведено фактори, які заважають або сприяють введенню системи соціальної відповідальності у закладах охорони здоров’я на поточному етапі медичної реформи в Україні. Виокремлені складові, критерії та коефіцієнти ефективності соціальної відповідальності закладу охорони здоров’я. Запропоновано схему механізму управління соціальною відповідальністю закладу охорони здоров’я. Виділені можливі напрямки впровадження програм соціальної відповідальності та очікувані результати. -/- Authors research questions of formation of the management system of (...) social responsibility of health care institution. The theoretical approaches to definition of social responsibility are classified, it is given factors that hinder or facilitate the implementation of social responsibility in health care institutions on current stage of medical reform in Ukraine. Constituents, criteria, and effectiveness coefficients of social responsibility of health care institutions are outlined. It is offered the scheme of management system mechanism of social responsibility of health care institutions. Possible ways of application of social responsibility programs are featured and expected results after implementation. (shrink)

Concerns of moral distress in health care have never been more relevant. In her book, Health Care Ethics Through the Lens of Moral Distress, Kristen Jones-Bonofiglio provides a comprehensive review of the effects of moral distress on providers and health care delivery, while highlighting the complexities of making ethical decisions in practice. Jones-Bonofiglio’s thoroughness and use of interdisciplinary, historical, and cultural scholarship makes this book an excellent introductory resource on moral distress for health (...) care providers and researchers alike. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of (...) research to improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

Universal health coverage (UHC) is at the center of current efforts to strengthen health systems and improve the level and distribution of health and health services. This document is the final report of the WHO Consultative Group on Equity and Universal Health Coverage. The report addresses the key issues of fairness and equity that arise on the path to UHC. As such, the report is relevant for every actor that affects that path and governments in (...) particular, as they are in charge of overseeing and guiding the progress toward UHC. (shrink)

Deep learning may transform health care, but model development has largely been dependent on availability of advanced technical expertise. The aim of this study is to develop a deep learning model to predict the gender from retinal fundus images. The proposed model was based on the Xception pre-trained model. The proposed model was trained on 20,000 retinal fundus images from Kaggle depository. The dataset was preprocessed them split into three datasets (training, validation, Testing). After training and cross-validating (...) the proposed model, it was evaluated using the testing dataset. The result of testing, the area under receiver operating characteristic curve (AUROC) of the model was 0.99, precision, recall, f1-score and accuracy were 99%, precision, recall, f1-score and accuracy were 96.83%, 96.83%, 96.82% and 96.83% respectively.. Clinicians are presently unaware of dissimilar retinal feature variants between females and males, stressing the importance of model explain ability for the prediction of gender from retinal fundus images. The proposed deep learning may enable clinician-driven automated discovery of novel visions and disease biomarkers. (shrink)

Now, the climate of Bangladesh has subtropical monsoon weather with extensive seasonal variations concerning humidity, temperature, and rainfall. Furthermore, it has altitudes from 600 to 1000 meters above sea level, whereas, at 1063 m(3,488 ft.) altitude, Saka Haphong at Mowdok range is the highest height in the southern part the hill there (Wasson, R., 2003). Bangladesh is an emerging market as a developing nation where approximately 30% of its GDP comes from agriculture to tell more about the country. However, Bangladesh (...) got its Independence from Pakistan in 1971, after the partition of British India in 1947 by a glorious liberation war. Before Independence, it had its map within a red circle surrounded by a rectangular green shape as the national flag. After Independence, the map got removed. The red circle signifies the blood sacrifice of the martyrs during the liberation war, while the green rectangle is the symbol of the country's green nature. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for (...) biomedical research involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

The Millennium Development Goals (MDG) set time-bound targets that are powerful shapers of how and for whom health is pursued. In this paper we examine some ramifications of both the temporal limitation, and maternal-child health targeting of MDG 4 and 5. The 2015 end date may encourage increasing the number of mass campaigns to meet the specific MDG objectives, potentially to the detriment of a more comprehensive approach to health. We discuss some ethical, political, and pragmatic ramifications (...) of this tendency, and show that these are not unique to the MDGs but rather have a long history in health policy debates. We also examine attempts to counter a narrow focus on vertical interventions in campaigns through integrated health system delivery platforms. We argue that the way forward is not to assume that evidence is value free, but rather to make explicit the political and ethical decisions in the design of metrics and evaluation research. We propose an index of five factors that should be included in research designed to inform decision making about providing interventions as part of routine services or periodic campaigns, toward serving more members of the population, and long-term strengthening of the health system via integrated health interventions. (shrink)

Most mental health research largely ignores or minimises gender and age differences in depression. In ‘Don't mind the gap: Why do we not care about the gender gap in mental health?’, Patalay and Demkowicz identify a dearth of research on the causal factors of depression in young women. They attribute this to an over-reliance on biological accounts of gender differences in depression. Patalay and Demkowicz conclude that a person-centred approach that meaningfully engages with the reports (...) of young women with depression is more likely to expose the social drivers of depression that impact this group. This commentary focuses on Patalay and Demkowicz's call to examine the patient's lived experience. We argue that there is an urgent need to reflect upon the methodologies involved in examining lived experience and how they can be best utilised. Ultimately, we advocate for an approach known as ‘phenomenological psychopathology’, through a phenomenological investigation of depression in young women, we can go some way towards closing the gender gap. (shrink)

Purpose Prescription stimulant use as “cognitive enhancers” has been described among undergraduate college students. However, the use of prescription stimulants among future health care professionals is not well characterized. This study was designed to determine the prevalence of prescription stimulant misuse among students at an academic health sciences center. -/- Method Electronic surveys were e-mailed to 621 medical, pharmacy, and respiratory therapy students at East Tennessee State University for four consecutive weeks in fall 2011. Completing the survey (...) was voluntary and anonymous. Surveys asked about reasons for, frequency of, and side effects of nonprescription misuse of prescription stimulants. Given the sensitive material, an opportunity to win one of ten $50 gift cards was used as an incentive. -/- Results Three hundred seventy-two (59.9%) students completed the survey from three disciplines (47.6% medical, 70.5% pharmacy, and 57.6% respiratory therapy). Overall, 11.3% of responders admitted to misusing prescription stimulants. There was more misuse by respiratory therapy students, although this was not statistically significant (10.9% medicine, 9.7% pharmacy, 26.3% respiratory therapy; P = .087). Reasons for prescription stimulant misuse included to enhance alertness/ energy (65.9%), to improve academic performance (56.7%), to experiment (18.2%), and to use recreationally/get high (4.5%). -/- Conclusions Prescription stimulant misuse was prevalent among participating students, but further research is needed to describe prevalence among future health care workers more generally. The implications and consequences of such misuse require further study across professions with emphasis on investigating issues of academic dishonesty (e.g., “cognitive enhancement”), educational quality, and patient safety or health care quality. (shrink)

This book provides a survey of the ethical aspects of health care resources distribution. It first distinguishes health from health care in an effort to clear up the ethical landscape. After this, still with the same purpose, it makes a distinction between problems of macro-allocation and micro-allocation. In the rest of the book two questions of macro-allocation are treated in some detail. First, several approaches – in particular: utilitarian, egalitarian, communitarian, and libertarian – to (...) the question whether we have a right to health care are assessed. Second, it is discussed how best, if we have such a right, health care resources are allocated given obvious budget constraints. Here again the major theories discussed are utilitarian, communitarian, and egalitarian. Although it is not the aim of the book to propose a new theory of the ethics of health care resource distribution, the critical approach throughout is broadly egalitarian in spirit. (shrink)

This thesis under the title “Public Health Policy in Resource Allocation: the Role of Ubuntu Ethics in Redressing Resource Disparity between Public and Private Healthcare in South Africa” explores health care disparities pertaining to resource allocation between public and private sector. It is of relevance and importance in South Africa where 54% of the population live on less than US$3 per day. Although the government has instituted certain changes aimed at transforming the public health care (...) system, the resource allocation gap between the two persists and remains wide. The research gives special attention to the role that Ubuntu ethics can play in redressing the resource allocation disparities between public and private health care sectors in South Africa, pointing out the existing gap in financing, as well as human resource between public and private health care sectors, which leads to poor health outcomes in public sector. Therefore, the problem is the prevalent inequality of resource allocation between private and public health care sectors. The analysis of policy gaps, as well as evaluating the cause of disparities in the health system is the goal of this research. The study endeavours to redress the disparities within the context of Ubuntu ethical principles and proposes a change in public policy so as to enhance healthcare for the benefit of the people. The study is philosophical and ethical, so the methodology used is discursive in nature, majorly focusing on critically reviewing existing literature, that is, the philosophical resources on Ubuntu ethics and justice theories as well as a range of government resources inclusive of public health policy documents. Social determinants of health and their impact in a South African context are discussed with the implication that health is not merely freedom from disease and or incapacity, but rather being well mentally, physically and socially. The attainment of a healthy status goes beyond ability to access healthcare services, and incorporates social determinants including but not limited to conditions in which people have been born into, stay, establish career and grow old in. It also includes the arrangements put in place to deal with illness and determine health. Issues of revenue, literacy, communal safety networks, vocation and conditions under-which vocation is undertaken, lack of work and vocation insecurity, early stages of human development, gender, cultural group, dietary insecurity, housing communal exclusion and disability all come into the picture as factors that determine health. But there is also discussion of the socio-economic status as contributors to health inequity wherein alcohol abuse, sugar intake, and smoking are identified as behavioural factors that complicate public health. One outstanding feature of this research is that it establishes a link between Ubuntu and public health policy. The researcher establishes that Ubuntu ethics is appropriate for not only discussing public morality, but also for formulating public policy that is morally tenable for South Africa, especially for the public health sector. This thesis calls for an application of Ubuntu in a proper context in order to enhance societal well-being for the benefit of many, if not all. The research proposes the fundamental principle of Ubuntu ethics in which the good of the community is as important as the good of every member of the community. Since Ubuntu ethics does not merely seek to fulfil what benefits the majority, as would be the case in a utilitarian society, the researcher advocates for the building of consensus on the common good, which should be understood to imply not just what is good for everyone in the community, but also what is good for the continued well-being of the community as a single unit. In this regard, the research finds it important that deliberate effort be made to integrate Ubuntu ethics into policies, citing the example of the National Health Insurance (NHI). The good health of all the members of a community is an assurance of the well-being and continuity of the whole national community. The research concludes that public health policy should integrate Ubuntu ethical values such as community, sharing, care, solidarity, identity, harmony, respect, and dignity into policy documents and legislation. (shrink)

Background: Dengue Disease is a mosquito-borne tropical disease caused by the dengue virus, symptoms typically begin three to fourteen days after infection. This may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic skin rash. Dengue serology is applied in different settings, such as for surveillance, in health care facilities in endemic areas and in travel clinics in non-endemic areas. The applicability and quality of serological tests in dengue endemic regions has to be (...) judged against a background of potential cross reactivity with other flavi-viruses, difficulties in distinguishing primary from secondary infections and technological problems related to the fact that most dengue endemic regions are relatively poor of resources .Objectives: to help doctors and patients in diagnosing Dengue Disease and give them the information of how to prevent Dengue Disease and to be able to understand the signs and symptoms of Dengue Disease. Methods: We collected all relevant material for Dengue Disease. Then we designed and implemented a knowledge based system for diagnosing Dengue Disease using SL5 Object Language. Results: The knowledge based system was evaluated by a group of Patients and specialized doctors and they found it very friendly and easy to use. (shrink)

A recent systematic review of Machine Learning (ML) approaches to health data, containing over 100 studies, found that the most investigated problem was mental health (Yin et al., 2019). Relatedly, recent estimates suggest that between 165,000 and 325,000 health and wellness apps are now commercially available, with over 10,000 of those designed specifically for mental health (Carlo et al., 2019). In light of these trends, the present chapter has three aims: (1) provide an informative overview of (...) some of the recent work taking place at the intersection of text mining and mental health so that we can (2) highlight and analyze several pressing ethical issues that are arising in this rapidly growing field and (3) suggest productive directions for how these issues might be better addressed within future interdisciplinary work to ensure the responsible development of text mining approaches in psychology generally, and in mental health fields, specifically. In Section 1, we review some of the recent literature on text-mining and mental health in the contexts of traditional experimental settings, social media, and research involving electronic health records. Then, in Section 2, we introduce and discuss ethical concerns that arise before, during, and after research is conducted. Finally, in Section 3, we offer several suggestions about how ethical oversight of text-mining research might be improved to be more responsive to the concerns mapped out in Section 2. (shrink)

Religion constitutes an important element in every society as regards coping with the demands as well as vicissitudes of life. Mental health issues are becoming a recurrent decimal in societies overwhelmed by stress and other social factors. This paper examines how the presence of religious beliefs affects how some Christians respond to cases that have to do mental health. At the same time, it surveys how a near absence of religious attitude, that is, clinical medicine approach to mental (...) health issues betters the state of those suffering from these psychopathologies. This work sees participatory partnership approach as an effective means of correcting unhealthy biases that prevent a better understanding of mental health care. Sociological theory of structural functionalism will be used in assessing how religion can reinvent itself in areas that are associated with mental health. Ethnographic methodology through quantitative analysis of administered questionnaire is used as a research tool for this research. Three persons were also interviewed. The research findings show that religion is a crucial agent of socialization that can change how religious beliefs impact on mental health and there is need for medical professionals to collaborate with pastoral agents. (shrink)

Recent epidemiological research on the social determinants of health has been used to attack an important framework, associated with Norman Daniels, that depicts healthcare as special. My aim is to rescue the idea that healthcare has special importance in society, although specialness will turn out to be mainly limited to clinical care. I build upon the link between Daniels's theory and the work of John Rawls to develop a conception of public justification liberalism that is suitable to (...) the field of justice and health. I argue that, from the perspective of public justification liberalism, (clinical) healthcare deserves special status. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional (...) role. I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

African Traditional Religion and medicine are integral parts of life and culture of the Africans and have greatly influenced their conceptions about human health and wholeness. Their many realities that Africans have not been able to abandon, in spite of the allurements of western civilization, Christianity, Islam and the advances in the biomedical sciences. The aim of this paper is to highlight the meaning of health and wholeness as central issues of concern in African Traditional Religion and Medicine. (...) The misconception, abuse and derogatory attitudes even from some notable Africans towards alternative medicine, as well as the all need of integrating both the alternative and orthodox medicine to bring about total wholeness, serves as the research problem. This paper argued that the biopsycho-socio-ecological model of health and wholeness is fundamental to the African Traditional Religion and Medicine. This model brings together the different aspects of human life and treats the human person as an integral and harmonious whole in perpetual relationship with the sacred, the human community and the environment. This paper therefore recommends that first, Africa has to open to modern medical discoveries and practices and secondly, African Traditional Religion and Medicine concern should be mainstreamed into the medical practice in health care services in contemporary Nigeria. It finally conclude that the alternative medicine despite the arrays of it inadequacies, objections and misconceptions, the practice has come to stay. (shrink)

The UN Convention against Torture defines torture as “any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person” by someone acting in an official capacity for purposes such as obtaining a confession or punishing or intimidating that person.1 It is unethical for healthcare professionals to participate in torture, including any use of medical knowledge or skill to facilitate torture or allow it to continue, or to be present during torture.2-7 Yet medical participation (...) in torture has taken place throughout the world and was a prominent feature of the US interrogation practice in military and Central Intelligence Agency (CIA) detention facilities in the years after the attacks of 11 September 2001.8-11 Little attention has been paid, however, to how a regime of torture affects the ability of health professionals to meet their obligations regarding routine clinical care for detainees. -/- The 2016 release of previously classified portions of guideline from the CIA regarding medical practice in its secret detention facilities sheds light on that question. These show that the CIA instructed healthcare professions to subordinate their fundamental ethical obligations regarding professional standards of care to further the objectives of the torturers. (shrink)

This study analyzed the monitoring and evaluation of HIV/AIDS prevention programs in Southern Senatorial District of Cross River State, Nigeria. The study considered different levels of care/support and tested for locational variations in the monitoring/evaluation of HIV/AIDs prevention programs. A descriptive survey research design was utilized. This study covered 596 public health employees (doctors, nurses, pharmacists, and laboratory employees) in the study area. A sample of 239 respondents was chosen using the proportional stratified random sampling procedure. Data (...) was collected using a questionnaire constructed by the researchers and validated by specialists. Data gathered were analyzed using descriptive and inferential statistics. Results indicated that HIV/AIDs programs have been successfully monitored/evaluated to a high extent. High rates of success in the monitoring/evaluation of HIV/AIDs prevention programs are attributable to high rates of care/support provided to people living with HIV/AIDs. There was a significant variation in the monitoring/evaluation of HIV/AIDs prevention programs based on the location of health facilities, with higher rates recorded for urban areas. Based on the findings, it was concluded that the monitoring/evaluation of HIV/AIDs prevention programs in the Southern Senatorial District of Cross River State had recorded a significant level of success. The study recommended, among others, that there should be even distribution of medical facilities, resources and personnel to both urban and rural areas to promote equity and access to materials needed to contain or mitigate the spread of the pandemic across all locations. (shrink)

Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better anticipate and address ethical concerns. Results Qualitative thematic analysis of the included articles revealed themes in three main areas: research design and ethics review, inclusion of research participants, (...) and communication of research results. Ethical issues known to be associated with genomic research in general, such as privacy risks and informed consent/assent, seem especially pressing for NDD participants because of their potentially decreased cognitive abilities, increased vulnerability, and stigma associated with mental health problems. Additionally, there are informational risks: learning genetic information about NDD may have psychological and social impact, not only for the research participant but also for family members. However, there are potential benefits associated with research participation, too: by enrolling in research, the participants may access genetic testing and thus increase their chances of receiving a (genetic) diagnosis for their neurodevelopmental symptoms, prognostic or predictive information about disease progression or the risk of concurrent future disorders. Based on the results of our review, we developed an ethics checklist for genomic research involving children affected by NDDs. Conclusions In setting up and designing genomic research efforts in NDD, researchers should partner with communities of persons with NDDs. Particular attention should be paid to preventing disproportional burdens of research participation of children with NDDs and their siblings, parents and other family members. Researchers should carefully tailor the information and informed consent procedures to avoid therapeutic and diagnostic misconception in NDD research. To better anticipate and address ethical issues in specific NDD studies, we suggest researchers to use the ethics checklist for genomic research involving children affected by NDDs presented in this paper. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that (...) scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

Shared decision-making involves health professionals and patients/clients working together to achieve true person-centred health care. However, this goal is infrequently realized, and most barriers are unknown. Discussion between philosophers, clinicians, and researchers can assist in confronting the epistemic and moral basis of health care, with benefits to all. The aim of this paper is to describe what shared decision-making is, discuss its necessary conditions, and develop a definition that can be used in practice to support (...) excellence in maternity care. Discussion between the authors, with backgrounds in philosophy, clinical maternity care, health care management, and maternity care research, assisted the team to confront established norms in maternity care and challenge the epistemic and moral basis of decision-making for caesarean section. The team concluded that shared decision-making must start in pregnancy and continue throughout labour and birth, with equality in discourse facilitated by the clinician. Clinicians have a duty of care for the adequacy of women's knowledge, which can only be fulfilled when relevant knowledge is offered freely and when personal beliefs and biases that may impinge on decision-making (defeaters) are disclosed. Informed consent is not shared decision-making. Key barriers include existing cultural norms of “the doctor knows best” and “patient acquiescence” that prevent defeaters being acknowledged and discussed and can lead to legal challenges, overuse of medical intervention and, in some areas, obstetric violence. Shared decision-making in maternity care can thus be defined as an enquiry by clinician and expectant woman aimed at deciding upon a course of care or none, which takes the form of a dialogue within which the clinician fulfils their duty of care to the client's knowledge by making available their complete knowledge (based on all types of evidence) and expertise, including an exposition of any relevant and recognized potential defeaters. Research to develop measurement tools is required. (shrink)

In recent years there has been an explosion of interest in Artificial Intelligence (AI) both in health care and academic philosophy. This has been due mainly to the rise of effective machine learning and deep learning algorithms, together with increases in data collection and processing power, which have made rapid progress in many areas. However, use of this technology has brought with it philosophical issues and practical problems, in particular, epistemic and ethical. In this paper the authors, with (...) backgrounds in philosophy, maternity care practice and clinical research, draw upon and extend a recent framework for shared decision-making (SDM) that identified a duty of care to the client's knowledge as a necessary condition for SDM. This duty entails the responsibility to acknowledge and overcome epistemic defeaters. This framework is applied to the use of AI in maternity care, in particular, the use of machine learning and deep learning technology to attempt to enhance electronic fetal monitoring (EFM). In doing so, various sub-kinds of epistemic defeater, namely, transparent, opaque, underdetermined, and inherited defeaters are taxonomized and discussed. The authors argue that, although effective current or future AI-enhanced EFM may impose an epistemic obligation on the part of clinicians to rely on such systems' predictions or diagnoses as input to SDM, such obligations may be overridden by inherited defeaters, caused by a form of algorithmic bias. The existence of inherited defeaters implies that the duty of care to the client's knowledge extends to any situation in which a clinician (or anyone else) is involved in producing training data for a system that will be used in SDM. Any future AI must be capable of assessing women individually, taking into account a wide range of factors including women's preferences, to provide a holistic range of evidence for clinical decision-making. (shrink)

Innovation is progressively needed in responding to global challenges. Moreover, the increasing complexity of challenges implies demand for the usage of multisectoral and policy mix approaches. Wicked problems can be tackled by "integrated innovation" that combines the coordinated implementation of social, technological, and health innovation co-created by entities of the public sector, the private sector, the non-governmental sector, and the informal sector. This Research Topic focuses on filling the knowledge gaps about the selected types of innovation. First, regarding (...) social innovation that can be understood as new strategies, concepts, products, services, and organizational forms that allow the satisfaction of human needs. Second, a technological innovation that refers to new or remarkably improved products, goods, or services in terms of their technical specifications, components, materials, software, design, or other functional features. Third, health innovation that focuses on novel or enhanced health policies, systems, products, technologies, services, and care delivery schemes to improve people’s health. Finally, this Research Topic highlights attempts to develop integrated innovation that can add value to social policy, health policy, and environmental policy by improving efficiency, effectiveness, quality, sustainability, safety, and affordability. (shrink)