ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

BackgroundThe COVID-19 pandemic has had a significant impact on the health system worldwide. The organ and tissue donation and transplantation (OTDT) system is no exception and has had to face ethical challenges related to the pandemic, such as risks of infection and resource allocation. In this setting, many Canadian transplant programs halted their activities during the first wave of the pandemic.MethodTo inform future ethical guidelines related to the COVID-19 pandemic or other public health emergencies of international concern, we conducted a (...) literature review to summarize the ethical issues.ResultsThis literature review identified three categories of ethical challenges. The first one describes the general ethical issues and challenges reported by OTDT organizations and transplantation programs, such as risks of COVID-19 transmission and infection to transplant recipients and healthcare professionals during the transplant process, risk of patient waitlist mortality or further resource strain where transplant procedures have been delayed or halted, and resource allocation. The second category describes ethical challenges related to informed consent in the context of uncertainty and virtual consent. Finally, the third category describes ethical issues related to organ allocation, such as social considerations in selecting transplant candidates.ConclusionThis literature review highlights the salient ethical issues related to OTDT during the current COVID-19 pandemic. As medical and scientific knowledge about COVID-19 increases, the uncertainties related to this disease will decrease and the associated ethical issues will continue to evolve. (shrink)

Science and technology studies (STS) research challenges the concept of technological determinism by investigating how the end users of a technology influence that technology’s trajectory. STS critiques of determinism are needed in studies of agricultural technology. However, we contend that focusing on the agency of end users may mask the role of political-economic factors which influence technology developments and applications. This paper seeks to mesh STS insights with political-economic perspectives by accounting for relationships between availability of diverse technologies, variations in (...) political-economic structures, and farmer interests and characteristics. We present the results of an analysis on the recent development of three wheat varieties: (a) a wheat variety that was modified genetically to tolerate the herbicide glyphosate, (b) wheat varieties with characteristics selected to serve specific markets, (c) and emerging research and development of perennial wheat varieties. Using data obtained through a survey of wheat growers in Washington State, we analyzed whether farmer interest in these three clusters of wheat varieties was associated with distinct individual characteristics and attitudes and whether those characteristics and attitudes are consistent with political economic structures. Although our analysis did not allow us to assess the degree of direct influence that farmers have on the technological development trajectory for these types of wheat, we were able to document variation in technological alternatives and farmer characteristics related to different political-economic trends. (shrink)

Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. Intervention The SPI1 (...) was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

Raanan Gillon is a noted defender of the four principles approach to healthcare ethics. His general position has always been that these principles are to be considered to be both universal and prima facie in nature. In recent work, however, he has made two claims that seem to present difficulties for this view. His first claim is that one of these four principles, respect for autonomy, has a special position in relation to the others: he holds that it is first (...) among equals. We argue that this claim makes little sense if the principles are to retain their prima facie nature. His second claim is that cultural variation can play an independent normative role in the construction of our moral judgments. This, he argues, enables us to occupy a middle ground between what he sees as the twin pitfalls of moral relativism and moral imperialism. We argue that there is no such middle ground, and while Gillon ultimately seems committed to relativism, it is some form of moral imperialism that will provide the only satisfactory construal of the four principles as prima facie universal moral principles. (shrink)

Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of (...) separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so. (shrink)

The Report of the Ad Hoc Adivisory Group on the Operation of NHS Research Ethics Committees has resulted in a strange mixture of the timid, the revolutionary, and the bizarre.The Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees is a curious document.1 The remit of the review was focused on the workings and effectiveness of NHS research ethics committees and the multicentre committees ). The Group was primarily set up in response to a (...) series of complaints from medical researchers about the new research governance regime in the UK as a result of the Clinical Trials Directive2 and the Governance Arrangements for NHS Research Ethics Committees.3 The opportunity was also taken to consider the role of research ethics committees in a wider context, and take account of recent developments in relation to the ethics review of social care research,4 student projects,5 as well as recent legislation such as the Human Tissue Act,6 and the Mental Capacity Act.7 However, the resulting report is a strange mixture of the timid, the revolutionary, and the bizarre.A good example of the report’s timidity is its reluctance to propose fundamental change to the process of review or seriously limit the type of research that requires REC review. To its credit AHAG does suggest that some research ‘especially surveys and many studies on NHS staff, could normally be conducted safely without a requirement for REC review’ .1 This is, of course, to be welcomed. However, the report ultimately seems dismissive of the general complaint from researchers that the current process is inappropriately uniform. For example, in section 3.2, it is argued that the ‘common perception that the NHS REC system is dominated …. (shrink)

The obligations of organisations associated with policy formation and implementation of international mass public health programmes are explored. Lines of responsibility are considered to become unclear because of the large number of agencies associated with such programmes. A separation of the relevant obligations among the bodies responsible for the formulation and those responsible for the implementation of the policies is suggested. The continuing oral polio vaccine campaign against poliomyelitis in India is used to illustrate the general argument. Although the aim (...) of the programme is legitimate and laudable, unnecessary harm is currently being caused to some children as a result of elements of the policy and this should be rectified immediately. Such mass programmes should take care to ensure that people are not unnecessarily sacrificed in the drive to attain the desirable ends of the policy. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of the (...) standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)

As initially envisioned, Gödel's Collected Works were to include transcriptions of material from his mathematical workbooks. In the end that material, as well as some other manuscript items from Gödel's Nachlass, had to be left out. This note describes some of the unpublished items in the Nachlass that are likely to attract the notice of scholars and surveys the extent of shorthand transcription efforts undertaken hitherto. Some examples of sources outside Gödel's Nachlass that may be of interest to Gödel scholars (...) are also indicated. (shrink)

The thesis of this article is that engagement and suffering are essential aspects of responsible caregiving. The sense of medical responsibility engendered by engaged caregiving is referred to herein as clinical phronesis, i.e. practical wisdom in health care, or, simply, practical health care wisdom. The idea of clinical phronesis calls to mind a relational or communicative sense of medical responsibility which can best be understood as a kind of virtue ethics, yet one that is informed by the exigencies of moral (...) discourse and dialogue, as well as by the technical rigors of formal reasoning. The ideal of clinical phronesis is not (necessarily) contrary to the more common understandings of medical responsibility as either beneficence or patient autonomy — except, of course, when these notions are taken in their disengaged form (reflecting the malaise of modern medicine). Clinical phronesis, which gives rise to a deeper, broader, and richer, yet also to a more complex, sense than these other notions connote, holds the promise both of expanding, correcting, and perhaps completing what it currently means to be a fully responsible health care provider. In engaged caregiving, providers appropriately suffer with the patient, that is, they suffer the exigencies of the patient's affliction (though not his or her actual loss) by consenting to its inescapability. In disengaged caregiving — that ruse Katz has described as the silent world of doctor and patient — provides may deny or refuse any given connection with the patient, especially the inevitability of the patient's affliction and suffering (and, by parody of reasoning, the inevitability of their own. When, however, responsibility is construed qualitatively as an evaluative feature of medical rationality, rather than quantitatively as a form of calculative reasoning only, responsibility can be viewed more broadly as not only a matter of science and will, but of language and communication as well — in particular, as the task of responsibly narrating and interpreting the patient's story of illness. In summary, the question is not whether phronesis can save the life of medical ethics — only responsible humans can do that! Instead, the question should be whether phronesis, as an ethical requirement of health care delivery, can prevent the death of medical ethics. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

There is widespread belief that connectionist networks are dramatically different from classical or symbolic models. However, connectionists rarely test this belief by interpreting the internal structure of their nets. A new approach to interpreting networks was recently introduced by Berkeley et al. (1995). The current paper examines two implications of applying this method: (1) that the internal structure of a connectionist network can have a very classical appearance, and (2) that this interpretation can provide a cognitive theory that cannot be (...) dismissed as a mere implementation. (shrink)

The papers in this issue of Public Health Ethics arise from a workshop on the role of political philosophy in public health ethics, held at Manchester Metropolitan University in September 2008.1 Part of the reason for exploring the role of political philosophy in relation to public health (and public health ethics) is the thought that the political is ineliminably social: it is about how we live together. Exactly what public health is and what it ought to be is contested, but (...) it surely involves the two senses of public in the sense of the object of attention (i.e., societal or population health) and also the mode of delivery (i.e., collective or participatory action) (Verweij and Dawson, 2007). Political philosophy is concerned with actions in the public sphere related to both these elements. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs,1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process.2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV as well (...) as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the difficulty of even engaging with community members in oppressive settings, where authorities severely restrict civil liberties of PWID so that even discussing issues related to drug use and enforcement may place individuals at risk. To overcome such limitations, he appropriately suggests interviewing confidentially those who have previously been detained in closed settings as part of the community engagement process. Similarly, Wolfe observes that critical issues can be overlooked with a narrow focus on study procedures if contextual factors before, during or after a study are ignored. For example, he cites the risk of overdose for study participants who have been abstinent during a study and subsequently resume injecting when the study concludes. These kinds of risks may not be obvious …. (shrink)

In crafting our paper on addressing the ethical challenges in HIV prevention research with people who inject drugs, 1 we had hoped to stimulate further discussion and deliberation about the topic. We are pleased that three commentaries on our paper have begun this process. 2 3 4 The commentaries rightly bring up important issues relating to community engagement and problems in translating research into practice in the fraught environments in which PWID face multiple risks. These risks include acquisition of HIV (...) as well as criminalisation, stigma and lack of access to needed healthcare, prevention and social services. We take this opportunity to respond to the excellent points raised by the commentators. All of the commentaries support our emphasis on robust community engagement with PWID and other stakeholders in designing and conducting HIV prevention research, but urge us to go farther. Wolfe highlights the... (shrink)

We are printing in its entirety the discussion document which sets out a code of professional conduct for nurses published by the Royal College of Nursing in November 1976 together with commentaries by the Assistant Secretary of the British Medical Association, a professor of nursing studies, student nurses and a lawyer. The image of the nurse is still that of one of Florence Nightingale's young ladies or of a member of a religious order who is wholly dedicated to caring for (...) the sick. Today, as this document and the comments upon it show, 'dedication' is still part of the motive which leads a man or woman to become a nurse but in addition, and this is where the public may be ignorant or choose to be ignorant, nursing offers a career where intellectual achievement and the satisfaction of a demanding job bring their proper financial reward and place in the professional community. We are grateful to the Royal College of Nursing for permission to publish this document. (shrink)

This paper examines whether a classical model could be translated into a PDP network using a standard connectionist training technique called extra output learning. In Study 1, standard machine learning techniques were used to create a decision tree that could be used to classify 8124 different mushrooms as being edible or poisonous on the basis of 21 different Features (Schlimmer, 1987). In Study 2, extra output learning was used to insert this decision tree into a PDP network being trained on (...) the identical problem. An interpretation of the trained network revealed a perfect mapping from its internal structure to the decision tree, representing a precise translation of the classical theory to the connectionist model. In Study 3, a second network was trained on the mushroom problem without using extra output learning. An interpretation of this second network revealed a different algorithm for solving the mushroom problem, demonstrating that the Study 2 network was indeed a proper theory translation. (shrink)

There is a large literature exploring the concept of ‘health promotion’. However, the meaning of the term remains unclear and contested. This is for at least two reasons. First, any definition of ‘health promotion’ is going to have to outline and defend an account of the notoriously controversial concept of ‘health’, and then suggest how (and why) we should promote it. Second, health promotion clearly has some overlap with ‘public health’, but it is far from clear how they are related. (...) Is health promotion part of public health or is health promotion a radically different type of activity from public health? Answering this question requires engaging with tricky professional as well as contentious conceptual issues. Some advocates of health promotion talk as though public health is problematic: seen as medical, physiological in focus and reductionist in approach, whereas health promotion, on this view, is focused on the whole person in a social environment. However, to an outsider this looks more like an attempt to artificially (and rather crudely) define and protect professional boundaries, rather than a contribution to conceptual analysis. There seems no good reason why public health cannot take into account the role of social, political, economic and cultural factors and their impact on health. Indeed, much work in public health does precisely this, and uses a wide range of methodologies drawn from non-medical disciplines such as geography, sociology and psychology, not just epidemiology. It seems much more sensible to see health promotion as being one vitally important aspect of the work of public health, rather than something markedly distinct. We will assume here that this is the case and focus instead on the first issue: what is health promotion? (shrink)

If stem cell-based therapies are developed, we will likely confront a difficult problem of justice: for biological reasons alone, the new therapies might benefit only a limited range of patients. In fact, they might benefit primarily white Americans, thereby exacerbating long-standing differences in health and health care.

Both the recent 'Warner' review of the UK research ethics committee (REC) system and the subsequent consultation document produced by the Central Office for Research Ethics Committees (COREC) emphasize the need to distinguish 'research' from what might be termed 'non-research'. This is to be determined through a process of filtering or 'triage', the intention being that RECs will avoid considering proposals with 'no material ethical issues'. In this paper we argue that trying to distinguish 'true' research from other projects is (...) counterproductive, misleading and potentially unethical. Our case is built around three assertions: (1) the distinction between research and non-research is imprecise; (2) both medical research and non-research can generate similar ethical issues; and (3) projects should be judged according to what they involve, not how they are labelled. (shrink)