Bayes’ rule shows how one might rationally change one’s beliefs in the light of evidence. It is the foundation of a statistical method called Bayesianism. In health care research, Bayesianism has its advocates but the dominant statistical method is frequentism. There are at least two important philosophical differences between these methods. First, Bayesianism takes a subjectivist view of probability (i.e. that probability scores are statements of subjective belief, not objective fact) whilst frequentism takes an objectivist view. Second, (...) Bayesianism is explicitly inductive (i.e. it shows how we may induce views about the world based on partial data from it) whereas frequentism is at least compatible with non-inductive views of scientific method, particularly the critical realism of Popper. Popper and others detail significant problems with induction. Frequentism’s apparent ability to avoid these, plus its ability to give a seemingly more scientific and objective take on probability, lies behind its philosophical appeal to health care researchers. However, there are also significant problems with frequentism, particularly its inability to assign probability scores to single events. Popper thus proposed an alternative objectivist view of probability, called propensity theory, which he allies to a theory of corroboration; but this too has significant problems, in particular, it may not successfully avoid induction. If this is so then Bayesianism might be philosophically the strongest of the statistical approaches. The article sets out a number of its philosophical and methodological attractions. Finally, it outlines a way in which critical realism and Bayesianism might work together. (shrink)

In order for children to receive the best possible medical treatment, it is essential that research is conducted to discover safe and effective interventions and dosages. This article focuses on the legal and ethical implications of recruiting into health-care research minors who are not competent to consent. It considers the role played by best interests in obtaining valid parental consent for the participation of children in research, both at common law and under the Regulations that (...) govern clinical trials of medicinal products. In doing so it questions the legality of parental consent to children's involvement in research, and identifies some inconsistencies in parental understandings of best interests in relation to medical research and treatment. (shrink)

A dearth of clinical research involving children has resulted in off-licence and sometimes inappropriate medications being prescribed to the paediatric population. In this environment, recent years have seen the introduction of a raft of regulation aimed at increasing the involvement of children in clinical trials research and generating evidence-based medicinal preparations for their use. However, this regulation pays scant attention to the autonomy of competent minors. In particular, it makes no provision for the ability of competent minors to (...) consent to participate in medical research and is therefore at odds with best ethical practice. This article explores the tensions between law and ethics in relation to clinical research involving minors and concludes that greater respect should be given to the autonomy of those minors who are competent to decide for themselves. (shrink)

The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

How should medical services be distributed within society? Who should pay for them? Is it right that large amounts should be spent on sophisticated technology and expensive operations, or would the resources be better employed in, for instance, less costly preventive measures? These and others are the questions addreses in this book. Norman Daniels examines some of the dilemmas thrown up by conflicting demands for medical attention, and goes on to advance a theory of justice in the distribution of (...) class='Hi'>health care. The central argument is that health care, both preventive and acute, has a crucial effect on equality of opportunity, and that a principle guaranteeing equality of opportunity must underly the distribution of health-care services. Access to care, preventive measures, treatment of the elderly, and the obligations of doctors and medical administrations are fully discussed, and the theory is shown to underwrite various practical policies in the area. (shrink)

Hope is a central concept in nursing and other fields of health care. However, there is no consensus about the concept of hope. We argue that seeking consensus is futile given the multifaceted and multidimensional nature of the concept, but instead we encourage in‐depth studies of the assumptions behind talk about hope in specific contexts. Our approach to the ‘science of hope’ is inspired by philosophical pragmatism. We argue that hope is a concept that opens different rooms for (...) action in different contexts and that accordingly, all hope interventions are contextually sensitive. Careful attention to how the relative positions and power of nurses and patients influence what can be inferred from their different ways of talking about hope may make hopeful conversations more meaningful in health care relationships. (shrink)

The aim of this article is to demonstrate the usefulness of qualitative research for studying the ethics of care, bringing to light the lived experience of health care recipients, together with the importance of methods that allow reconstruction of the processes underlying this lived experience. Lived experiences of families being approached for organ donation, parents facing the imminent death of their child and patients being treated using stem cell transplantation are used to illustrate how ethical principles (...) are differentiated, modified or contradicted by the narrative context of persons concerned. The integration of empirical data into ethics will help caregivers in their ethical decision making and may enrich care ethics as a narrative and interpretative field. (shrink)

In a large proportion of health care research based on the retrospective review of records, minimal breach of patient confidentiality appears to be inevitable. This occurs at initial identification of and access to the chart, selected on the basis of the condition under investigation, and while individual identifiability can be blocked at subsequent stages, at this point it does occur. Prospective individual consent is impractical because often neither the desirability nor the specific subject of the research (...) is known at the time of making the record, and retrospective patient tracing to obtain it is often impossible. I argue that the benefit of the research outweighs the minimal breach of confidentiality, and that in my own jurisdiction, this appears to be envisaged and accepted in Canadian law. (shrink)

One of the core problems of scientific research authorship is honorary authorship. It violates the ethical principle of clear and appropriate assignment of scientific research contributions. The prevalence of honorary authorship worldwide is alarmingly high across various research disciplines. As a result, many academic institutions and publishers were trying to explore ways to overcome this unethical research practice. The International Committee of Medical Journal Editors (ICMJE) recommended criteria for authorship as guidance for researchers submitting manuscripts to (...) biomedical Journals. However, despite the ICMJE guidelines, honorary authorship is still significantly present across various health research disciplines. The aim of this study was to explore the perceptions and knowledge of health care researchers towards honorary authorship according to the ICMJE guidelines across different health care fields in Jordan, which to our knowledge was never explored before. Data from an electronic survey that was distributed among researchers working in different healthcare fields across several major universities in Jordan, revealed that most of the respondents were assistant professors working mainly in the schools of Medicine and Pharmacy. The majority of the respondents (65.5%) were not aware of the ICMJE authorship guidelines. And, around 37% reported the inclusion of an honorary author, in which the most common non-authorship task reported by 73% of the respondents was reviewing the manuscript. Our findings emphasize the need for national academic and research institutions to address the issue of authorship in their educational programs and internal policies. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 29-31, May–June 2022.

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the (...) accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making.Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments.DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system.Trial RegistrationISRCTN89993391. (shrink)

The fifth volume of essays in medical ethics and law produced by the King's College Centre of Medical Law and Ethics. Issues addressed include a discussion of the ethics and epistemology of clinical research, the validation of therapies and topical concern.

Hastings Center Report, Volume 52, Issue 3, Page 18-29, May–June 2022.

The primary objective of The Health Care Ethics Con sultant is to focus attention on an immediate practical problem: the role and responsibilities, the education and training, and the certification and accreditation of health care ethics consultants. The principal questions addressed in this book include: Who should be considered health care ethics consultants? Whom should they advise? What should be their responsi bilities and what kind of training should they have? Should there be some (...) kind of accreditation or certification program to ensure that those who call themselves ethics consultants are in fact qualified to advise, consult, research, and write in health care ethics? The distinguished authors ofthese articles are persons with diverse backgrounds, interests, presumptions, and val ues. Not surprisingly, therefore, diverse responses have emerged to the questions posed. Though the book's chapters are individually authored, they are informed by the group discussions that went on during active workshop sessions, and by knowledge of the contributions of others. All of the chapters meaningfully represent their consensus. This is not to say that there were no disagreements regarding specific details, but rather that there were no fundamental objections on the book's basic content among a panel of authors who share basic premises regarding the role, responsibilities, education, and certifica tion of health care ethics consultants. (shrink)

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions (...) may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

Very few data exist in France on: (1) nurses’ knowledge and behaviour concerning ethical decisions in clinical practice; and (2) their knowledge of ethical rules in clinical research. This questionnaire-based audit tried mainly to assess these questions in a large French university teaching hospital. Of the 257 questionnaires distributed to nurses in 23 clinical units of the hospital, 206 were returned (80% response rate). When responding to the vignette describing a clinical situation requiring an ethical decision to be made, (...) most nurses acted as the patient’s advocate although they have had no formal training in ethics. Indeed, 66% of nurses responding considered that the patients themselves should be the primary decision makers in situations that relate to their health and medical care. For children or comatose patients, the decision should be left to the relatives according to 72% of the responses. The results indicated that the role of health care professionals in ethical decisions made for a given patient should be marginal. Nurses’ knowledge concerning research protocols, particularly their ethical requirements and consequences, is poor at present and information from and communication with doctors should be improved. (shrink)

Very few data exist in France on: nurses’ knowledge and behaviour concerning ethical decisions in clinical practice; and their knowledge of ethical rules in clinical research. This questionnaire-based audit tried mainly to assess these questions in a large French university teaching hospital. Of the 257 questionnaires distributed to nurses in 23 clinical units of the hospital, 206 were returned. When responding to the vignette describing a clinical situation requiring an ethical decision to be made, most nurses acted as the (...) patient’s advocate although they have had no formal training in ethics. Indeed, 66% of nurses responding considered that the patients themselves should be the primary decision makers in situations that relate to their health and medical care. For children or comatose patients, the decision should be left to the relatives according to 72% of the responses. The results indicated that the role of health care professionals in ethical decisions made for a given patient should be marginal. Nurses’ knowledge concerning research protocols, particularly their ethical requirements and consequences, is poor at present and information from and communication with doctors should be improved. (shrink)

Rationing is the allocation of a good under conditions of scarcity, which necessarily implies that some who want and could be benefitted by that good will not receive it. One reflection of our ambivalence towards health care rationing is reflected in our resistance to having it distributed in a market like most other goods—most Americans reject ability to pay as the basis for distributing health care. They do not view health care as just another (...) commodity to be distributed by markets. Despite this widespread view, we are the only developed country without some form of universal health insurance, and so for the 46 million Americans without health insurance their access to health care often does depend on their ability to pay for it. Rationing largely remains a topic that the public, their elected leaders, and many health care professionals prefer to avoid. Ever-growing costs of health care will increasingly force the practice and issue of health care resource prioritization and rationing into the open for public, professional, and political attention. This paper explores some of the features of those practices and issues that make them especially ethically and politically difficult. Those issues will not be easily resolved, but avoiding them will not avoid the need or reality of rationing, it will only mean that it will go on covertly and unexamined. That will lead neither to better or more legitimate prioritization and rationing decisions. (shrink)

In the Caribbean as in many other areas costly biomedical resources and personnel are limited, and more and more people are turning to alternative medicine and folk practitioners for health care. To meet the goal of providing health care for all, research on nonbiomedical therapies is needed, along with legal recognition of folk practitioners to establish standards of practice.

Community-based mental health care providers are increasingly contacted by external researchers for research study recruitment. Unfortunately, many do not possess the resources or personn...

Genomics is increasingly becoming an integral component of health research and clinical care. The perceived difficulties associated with genetic research involving Aboriginal and Torres Strait Islander people mean that they have largely been excluded as research participants. This limits the applicability of research findings for Aboriginal and Torres Strait Islander patients. Emergent use of genomic technologies and personalised medicine therefore risk contributing to an increase in existing health disparities unless urgent action is taken. (...) To allow the potential benefits of genomics to be more equitably distributed, and minimise potential harms, we recommend five actions: ensure diversity of participants by implementing appropriate protocols at the study design stage; target diseases that disproportionately affect disadvantaged groups; prioritise capacity building to promote Indigenous leadership across research professions; develop resources for consenting patients or participants from different cultural and linguistic backgrounds; and integrate awareness of issues relating to Indigenous people into the governance structures, formal reviews, data collection protocols and analytical pipelines of health services and research projects. (shrink)

Rationing is the allocation of a good under conditions of scarcity, which necessarily implies that some who want and could be benefitted by that good will not receive it. One reflection of our ambivalence towards health care rationing is reflected in our resistance to having it distributed in a market like most other goods—most Americans reject ability to pay as the basis for distributing health care. They do not view health care as just another (...) commodity to be distributed by markets. Despite this widespread view, we are the only developed country without some form of universal health insurance, and so for the 46 million Americans without health insurance their access to health care often does depend on their ability to pay for it. Rationing largely remains a topic that the public, their elected leaders, and many health care professionals prefer to avoid. Ever-growing costs of health care will increasingly force the practice and issue of health care resource prioritization and rationing into the open for public, professional, and political attention. This paper explores some of the features of those practices and issues that make them especially ethically and politically difficult. Those issues will not be easily resolved, but avoiding them will not avoid the need or reality of rationing, it will only mean that it will go on covertly and unexamined. That will lead neither to better or more legitimate prioritization and rationing decisions. (shrink)

The SARS-CoV-2 pandemic has highlighted the interdependency of healthcare systems and research organizations on manufacturers and suppliers of personnel protective equipment and the need for well-trained personnel who can react quickly to changing working conditions. Reports on challenges faced by research laboratory workers are rare in contrast to the lived experience of hospital health care workers. We report on experiences gained by RLWs who significantly contributed to combating the pandemic under particularly challenging conditions due to increased (...) workload, sickness and interrupted PPE supply chains. RLWs perform a broad spectrum of work with SARS-CoV-2 such as autopsies, establishment of virus cultures and infection models, development and verification of diagnostics, performance of virus inactivation assays to investigate various antiviral agents including vaccines and evaluation of decontamination technologies in high containment biological laboratories. Performance of autopsies and laboratory work increased substantially during the pandemic and thus led to highly demanding working conditions with working shifts of more than eight hours working in PPE that stressed individual limits and also the ergonomic and safety limits of PPE. We provide detailed insights into the challenges of the stressful daily laboratory routine since the pandemic began, lessons learned, and suggest solutions for better safety based on a case study of a newly established HCBL designed for autopsies and research laboratory work. Reduced personal risk, increased resilience, and stress resistance can be achieved by improved PPE components, better training, redundant safety measures, inculcating a culture of safety, and excellent teamwork. (shrink)

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation (...) in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels. (shrink)

Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.

The application of machine learning in health care holds great promise for improving care. Indeed, our own team is collaborating with experts in machine learning and statistical modeling to bu...

This book is a collection of articles about communication and ethics in the field of medicine and health care. Common to all the articles is that they are not directly based on empirical investigations. The discussions refer to research, but this is research that has already been carried out and documented in existing literature. In this sense the articles belong to what is often called applied philosophy. All the articles address communicative and ethical challenges in patient (...) interaction on the basis of assumptions in modern moral philosophy and philosophy of language. There is a great need for literature that deals more comprehensively with the themes in this book than many introductory books do. It is particularly difficult to find suitable reading material that can be used in teaching at graduate and master levels. This book is designed to meet this need. It is suitable for use in all higher-level courses where the aim is to give students a theoretical understanding of ethical dilemmas and communicative challenges in health care. (shrink)

This paper presents a systematic account of ethical issues actualised in different areas, as well as at different levels and stages of health care, by introducing organisational and other procedures that embody a shift towards person centred care and shared decision-making (PCC/SDM). The analysis builds on general ethical theory and earlier work on aspects of PCC/SDM relevant from an ethics perspective. This account leads up to a number of theoretical as well as empirical and practice oriented issues (...) that, in view of broad advancements towards PCC/SDM, need to be considered by health care ethics researchers. Given a PCC/SDM-based reorientation of health care practice, such ethics research is essential from a quality assurance perspective. (shrink)

BackgroundAs hospitals have grown more complex, the ethical concerns they confront have grown correspondingly complicated. Many hospitals have consequently developed health care ethics programs (HCEPs) that include far more than ethics consultation services alone. Yet systematic research on these programs is lacking.MethodsBased on a national, cross-sectional survey of a stratified sample of 600 US hospitals, we report on the prevalence, scope, activities, staffing, workload, financial compensation, and greatest challenges facing HCEPs.ResultsAmong 372 hospitals whose informants responded to an (...) online survey, 97% of hospitals have HCEPs. Their scope includes clinical ethics functions in virtually all hospitals, but includes other functions in far fewer hospitals: ethical leadership (35.7%), regulatory compliance (29.0%), business ethics (26.2%), and research ethics (12.6%). HCEPs are responsible for providing ongoing ethics education to various target audiences including all staff (77.0%), nurses (59.9%), staff physicians (49.0%), hospital leadership (44.2%), medical residents (20.3%) and the community/general public (18.4%). HCEPs staff are most commonly involved in policy work through review of existing policies but are less often involved in development of new policies. HCEPs have an ethics representative in executive leadership in 80.5% of hospitals, have representation on other hospital committees in 40.7%, are actively engaged in community outreach in 22.6%, and lead large-scale ethics quality improvement initiatives in 17.7%. In general, major teaching hospitals and urban hospitals have the most highly integrated ethics programs with the broadest scope and greatest number of activities. Larger hospitals, academically affiliated hospitals, and urban hospitals have significantly more individuals performing HCEP work and significantly more individuals receiving financial compensation specifically for that work. Overall, the most common greatest challenge facing HCEPs is resource shortages, whereas underutilization is the most common greatest challenge for hospitals with fewer than 100 beds. Respondents’ strategies for managing challenges include staff training and additional funds.ConclusionsWhile this study must be cautiously interpreted due to its limitations, the findings may be useful for understanding the characteristics of HCEPs in US hospitals and the factors associated with these characteristics. This information may contribute to exploring ways to strengthen HCEPs. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a (...) new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)