Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

Due to their understanding of self-management, healthcare team members responsible for depressed older persons can experience an ethical dilemma. Each team member contributes important knowledge and experience pertaining to the management of depression, which should be reflected in the management plan. The aim of this study was to explore healthcare team members’ reflections on the ethical dilemmas involved in promoting self-management among depressed older persons. A qualitative design was used and data were collected by means of focus group interviews. The (...) results revealed one main theme: ‘Lack of trust in the community health care system’s commitment to bringing about effectiveness and change, based on three themes; ‘Struggling to ensure the reliable transfer of information about depressed older persons to professionals and family members’, ‘Balancing autonomy, care and dignity’ and ‘Differences in the understanding of responsibility’. Lack of engagement on the part of and trust between the various professional categories who work in the community are extremely counterproductive and have serious implications for patient dignity as well as safety. In conclusion, ethical dilemmas occur when staff members are unable to act in accordance with their professional ethical stance and deliver an appropriate standard of care. (shrink)

Introduction Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where the first author (...) lives and works, as a case study. Methods Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. Results We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. Conclusion While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities. (shrink)

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (shrink)

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is (...) fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. (shrink)

Background: While sustainability is a key concept in many different domains today, it has not yet been sufficiently emphasized in the healthcare sector. Earlier research shows that ethical values and evidence-based care models create sustainability in care practice. Objective: The aim of this study was to gain further understanding of the ethical values central to the realization of sustainability in care and to create an ethical practice model whereby these basic values can be made perceptible and active in care practice. (...) Research design: Part of the ongoing “Ethical Sustainable Caring Cultures” research project, a hermeneutical application research design was employed in this study. Participants: Dialogues were used, where scientific researchers and co-researchers were given the opportunity to reflect on ethical values in relation to sustainability in care. Findings: An ethical practice model with ethos as its core was created from the results of the dialogues. In the model, ethos is encircled by the ethical values central to sustainability: dignity, responsibility, respect, invitation, and vows. Discussion: The model can be used as a starting point for ethical conversations that support carers’ reflections on the ethical issues seen in day-to-day care work and the work community, allowing ethical values to become visible throughout the entire care culture. Conclusion: It is intended as a tool whereby carers can more deeply understand an organization’s common basic values and what they entail in regard to sustainability in care. (shrink)

Current UK guidelines regarding clinical research on children permit research that is non-therapeutic from the perspective of that particular child. The guidelines permit research interventions that cause temporary pain, bruises or scars. It is argued here that such research conflicts with the Declaration of Helsinki according to which the interests of the research subject outweigh all other interests. Given this, in the context of clinical research, who is best placed to protect the child from this kind of exploitation? Is it (...) the medical researcher, the child’s parents or the nurse advocate? This article describes the problem, possible responses to it, and closes with a consideration of, and rejection of, a defence of current guidelines that claims moral parity between clinical research and clinical education. (shrink)

Der Unterricht in Medizinethik soll Medizinstudierenden die Grundlagen dafür vermitteln, in ihrer zukünftigen ärztlichen Tätigkeit gute Entscheidungen treffen zu können. Im Rahmen einer Panelstudie wird derzeit die Entwicklung moralischer Positionen, medizinethischer Kenntnisse und Motivationen von Medizinstudierenden der Ludwig-Maximilians-Universität München über den Verlauf des Studiums untersucht. Für die Datenerhebung wurde ein Fragebogen entwickelt, der medizinethische Positionen und Kenntnisse sowie Motivationen erfasst. Im Wintersemester 2009/10 wurde die erste Querschnittsuntersuchung mit Studierenden im 1., 3. und 8. Semester sowie im Praktischen Jahr durchgeführt. Die (...) Mehrzahl der Befragten verfügte über einen geringen Kenntnisstand in verschiedenen Themenbereichen des Unterrichtsfachs GTE. Rechtliche Grundlagen und praktische Umsetzung von Therapiebegrenzungsmaßnahmen waren bis ins PJ-Semester vielen Studierenden nicht bekannt. Im Verlauf des Studiums veränderten sich die Motivationen weg von der Motivation, Menschen helfen zu wollen, hin zu Wissenserwerb und dem Ergreifen eines sicheren Berufs. Obwohl viele Befragte ein hohes Interesse an medizinethischen Fragestellungen und Unterricht im Bereich GTE angaben, zeigte sich kein nachhaltiger Zuwachs an medizinethischen Kenntnissen im Laufe des Studiums. In der Zusammenschau werfen die Ergebnisse die Frage auf, inwieweit verschiedene Ausbildungskonzepte Einfluss auf die individuelle ethische Entwicklung Medizinstudierender nehmen können. Eine Untersuchung dieser Fragestellung bleibt Gegenstand weitergehender Forschung. (shrink)

Background: Dignity has been highlighted in previous research as one of the most important ethical concerns in nursing care. According to Eriksson, dignified caring is related to treating the patient as a unique human being and respecting human value. Intensive care unit patients are vulnerable to threatened dignity, and maintaining dignity may be challenging as a consequence of critical illness. Objectives: The aim is to highlight how nurses in an intensive care setting understand patient dignity, what threatens patient dignity and (...) how nurses can safeguard patient dignity. Research design and participants: Data materials were collected through a survey questionnaire which contained open questions about patient dignity, and the text was analysed using hermeneutic reading and text interpretation. Totally, 25 nurses employed in an intensive care unit in Finland participated in the study. Ethical considerations: The study follows the guidelines for good scientific practice by the Finnish Advisory Board on Research Integrity and the ethical principles according to the Declaration of Helsinki. Findings: Findings revealed that nurses recognize the patients’ absolute dignity by regarding them as unique human beings. The nurses also recognize the importance of shared humanity in preserving patient dignity. Intensive care patients’ dignity is threatened by negative attitudes and when their integrity is not being protected. Dignity is also threatened when patients and nurses are not part of the patients’ care and patient care decisions, when patients receive care against their will and because of the acute nature of intensive care. (shrink)