Background: Although genetic research into Alzheimer disease (AD) is increasing, the ethical aspects of this kind of research and the differences between ethical issues related to genetic and non-genetic research into AD have not yet received much attention. Objectives: (1) To identify and compare the five ethical issues considered most important by surveyed expert panellists in non-genetic and genetic AD research and (2) to compare our empirical findings with ethical issues in genetic research in general as described in the literature. (...) Method: A modified Delphi study in two rounds Results: Genetic and non-genetic research into AD generated an approximately equal number of topics with a considerable overlap. Different priorities in the ethics of both types of research were found. Genetic research raised new topics such as “confidentiality of genetic information” and “implications of research for relatives” which changes the impact and application of existing ethical topics such as “informed consent” and is judged to have more impact on both individuals and society. A difference with the results of more theoretical approaches on ethical aspects related to AD research was also found. Conclusions: Different priorities are given to ethical issues in genetic and non-genetic research. These arise partly because genetic research causes unique and new questions, mostly related to the position of family members and the status of and access to genetic information. Differences found between the results of our empirical study and the more theoretical literature, suggest an additional value for empirical research in medical ethics. (shrink)

Background Regionalised models of health care delivery have important implications for people with disabilities and chronic illnesses yet the ethical issues surrounding disability and regionalisation have not yet been explored. Although there is ethics-related research into disability and chronic illness, studies of regionalisation experiences, and research directed at improving health systems for these patient populations, to our knowledge these streams of research have not been brought together. Using the Canadian province of Ontario as a case study, we address this gap (...) by examining the ethics of regionalisation and the implications for people with disabilities and chronic illnesses. The critical success factors we provide have broad applicability for guiding and/or evaluating new and existing regionalised health care strategies. Discussion Ontario is in the process of implementing fourteen Local Health Integration Networks (LHINs). The implementation of the LHINs provides a rare opportunity to address systematically the unmet diverse care needs of people with disabilities and chronic illnesses. The core of this paper provides a series of composite case vignettes illustrating integration opportunities relevant to these populations, namely: (i) rehabilitation and services for people with disabilities; (ii) chronic illness and cancer care; (iii) senior's health; (iv) community support services; (v) children's health; (vi) health promotion; and (vii) mental health and addiction services. For each vignette, we interpret the governing principles developed by the LHINs – equitable access based on patient need, preserving patient choice, responsiveness to local population health needs, shared accountability and patient-centred care – and describe how they apply. We then offer critical success factors to guide the LHINs in upholding these principles in response to the needs of people with disabilities and chronic illnesses. Summary This paper aims to bridge an important gap in the literature by examining the ethics of a new regionalisation strategy with a focus on the implications for people with disabilities and chronic illnesses across multiple sites of care. While Ontario is used as a case study to contextualize our discussion, the issues we identify, the ethical principles we apply, and the critical success factors we provide have broader applicability for guiding and evaluating the development of – or revisions to – a regionalised health care strategy. (shrink)

Empirical ethics research is increasingly valued in bioethics and healthcare more generally, but there remain as yet under-researched areas such as pharmacy, despite the increasingly visible attempts by the profession to embrace additional roles beyond the supply of medicines. A descriptive and critical review of the extant empirical pharmacy ethics literature is provided here. A chronological change from quantitative to qualitative approaches is highlighted in this review, as well as differing theoretical approaches such as cognitive moral development and the four (...) principles of biomedical ethics. Research with pharmacy student cohorts is common, as is representation from American pharmacists. Many examples of ethical problems are identified, as well as commercial and legal influences on ethical understanding and decision making. In this paper, it is argued that as pharmacy seeks to develop additional roles with concomitant ethical responsibilities, a new prescription is needed for empirical ethics research in pharmacy—one that embraces an agenda of systematic research using a plurality of methodological and theoretical approaches to better explore this under-researched discipline. (shrink)

Background The recent proliferation of health care report cards, especially in cardiac care, has occurred in the absence of an ethical framework to guide in their development and implementation. An ethical framework is a consistent and comprehensive theoretical foundation in ethics, and is formed by integrating ethical theories, relevant literature, and other critical information (such as the views of stakeholders). An ethical framework in the context of cardiac care provides guidance for developing cardiac report cards (CRCs) that are relevant and (...) legitimate to all stakeholders. The purpose of this study is to develop an ethical framework for CRCs. Methods Delphi technique – 13 panelists: 2 administrators, 2 cardiac nurses, 5 cardiac patients, 2 cardiologists, 1 member of the media, and 1 outcomes researcher. Panelists' views regarding the ethics of CRCs were analyzed and organized into themes. Results We have organized panelists' views into ten principles that emerged from the data: 1) improving quality of care, 2) informed understanding, 3) public accountability, 4) transparency, 5) equity, 6) access to information 7) quality of information, 8) multi-stakeholder collaboration, 9) legitimacy, and 10) evaluation and continuous quality improvement. Conclusion We have developed a framework to guide the development and dissemination of CRCs. This ethical framework can provide necessary guidance for those generating CRCs and may help them avoid a number of difficult issues associated with existing ones. (shrink)

Aims: The aims of the study were to explore expert opinion on the distinction between “research” and “audit”, and to determine the need for review by a National Health Service (NHS) Research Ethics Committee (REC). Background: Under current guidelines only “research” projects within the NHS require REC approval. Concerns have been expressed over difficulties in distinguishing between research and other types of project, and no existing guidelines appear to have been validated. The implications of this confusion include unnecessary REC applications, (...) and crucially, the potential for ethically unsound projects to escape review. Methods: A three-stage Delphi method was chosen to explore expert opinion and develop consensus. Stage 1 comprised ten semi-structured interviews gathering opinion on distinguishing between types of project and how to determine need for ethical review. Stages 2 and 3 were questionnaires, asking 24 “experts” to rate levels of ethical concern and types of project for a series of questions. Anonymised responses from stage 2 were fed back in stage 3. The final responses were analysed for consensus. Results: Of 46 questions, consensus was achieved for 14 (30.4%) for level of ethical concern and for 15 (32.6%) for type of project. Conclusions: Several ideas proved discriminatory for classifying the type of project and assessing level of ethical concern, and they can be used to develop an algorithm to determine need for ethical review. There was little relationship between assessment of the level of ethical concern and classification of the project. There was inconsistency in defining and classifying studies as something other than “research” or “audit”. (shrink)

Objective—Consultation of another physician is an important method of review of the practice of euthanasia. For the project “support and consultation in euthanasia in Amsterdam” which is aimed at professionalising consultation, a protocol for consultation was developed to support the general practitioners who were going to work as consultants and to ensure uniformity. Participants—Ten experts (including general practitioners who were experienced in euthanasia and consultation, a psychiatrist, a social geriatrician, a professor in health law and a public prosecutor) and the (...) general practitioners who were going to use the protocol. Evidence—There is limited literature on consultation: discursive articles and empirical studies describing the practice of euthanasia. Consensus—An initial draft on the basis of the literature was commented on by the experts and general practitioners in two rounds. Finally, the protocol was amended after it had been used during the training of consultants. Conclusions—The protocol differentiates between steps that are necessary in a consultation and steps that are recommended. Guidelines about four important aspects of consultation were given: independence, expertise, tasks and judgment of the consultant. In 97% of 109 consultations in which the protocol was used the consultant considered the protocol to be useful to a greater or lesser extent. Although this protocol was developed locally, it also employs universal principles. Therefore it can be of use in the development of consultation elsewhere. (shrink)

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this (...) issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation. (shrink)

Background There are numerous ethical challenges that can impact patients and families in the health care setting. This paper reports on the results of a study conducted with a panel of clinical bioethicists in Toronto, Ontario, Canada, the purpose of which was to identify the top ethical challenges facing patients and their families in health care. A modified Delphi study was conducted with twelve clinical bioethicist members of the Clinical Ethics Group of the University of Toronto Joint Centre for Bioethics. (...) The panel was asked the question, what do you think are the top ten ethical challenges that Canadians may face in health care? The panel was asked to rank the top ten ethical challenges throughout the Delphi process and consensus was reached after three rounds. Discussion The top challenge ranked by the group was disagreement between patients/families and health care professionals about treatment decisions. The second highest ranked challenge was waiting lists. The third ranked challenge was access to needed resources for the aged, chronically ill, and mentally ill. Summary Although many of the challenges listed by the panel have received significant public attention, there has been very little attention paid to the top ranked challenge. We propose several steps that can be taken to help address this key challenge. (shrink)