In 2001, leaders with palliative care convened to discuss the standardization of palliative care and formed the National Consensus Project for Quality Palliative Care. In 2004, the National Consensus Project for Quality Palliative Care produced the first edition of Clinical Guidelines for Quality Palliative Care. The Guidelines were developed by leaders in the field who examined other national and international standards with the intent to promote consistent, accessible, comprehensive, optimal palliative care (...) through the health care spectrum. Within the guidelines there are eight domains to the provision of palliative care. This article focuses on the last, but very significant Domain 8—Ethical and Legal Aspects of Care. (shrink)

Background and AimsEnd-of-life discussions can be difficult for seriously ill adolescents and young adults. Researchers aimed to determine whether completing Voicing My CHOiCES —a research-informed advance care planning guide—increased communication with family, friends, or health care providers, and to evaluate the experience of those with whom VMC was shared.MethodsFamily, friends, or HCPs who the AYAs had shared their completed VMC with were administered structured interviews to assess their perception of the ACP discussion, changes in their relationship, conversation (...) class='Hi'>quality, and whether the discussion prompted changes in care. Open-ended responses underwent thematic analysis.ResultsOne-month post-completion, 65.1% of AYA had shared VMC completion with a family member, 22.6% with a friend, and 8.9% with an HCP. Among a sample of respondents, family and friends reported a positive change in their relationship with the AYA. Participant descriptions of the experience fell into five themes: positive experience, difficult experience, appreciated a guide to facilitate discussion, provided relief, and created worry/anxiety. Only 1 HCP noted a treatment change. Family, friends, and HCP did not think the AYA would have discussed EoL preferences without completing VMC.ConclusionsVMC has potential to enhance communication about ACP between AYA and their family and friends, though less frequently with HCPs. Participants reported a positive change in their relationship with the AYA after discussing VMC, and described experiencing the conversation as favorable, even when also emotionally difficult. (shrink)

Background: Many nursing homes appear as multicultural workplaces where the majority of healthcare providers have an ethnic minority background. This environment creates challenges linked to communication, interaction and cultural differences. Furthermore, the healthcare providers have varied experiences and understanding of what quality care of patients with dementia involves. Purpose: The aim of this study is to illuminate multi-ethnic healthcare providers’ lived experiences of their own working relationship, and its importance to quality care for people with dementia. (...) Research design: The study is part of a greater participatory action research project: ‘Hospice values in the care for persons with dementia’. The data material consists of extensive notes from seminars, project meetings and dialogue-based teaching. The text material was subjected to phenomenological-hermeneutical interpretation. Participants and research context: Participants in the project were healthcare providers working in a nursing home unit. The participants came from 15 different countries, had different formal qualifications, varied backgrounds and ethnic origins. Ethical considerations: The study is approved by the Norwegian Regional Ethics Committee and the Norwegian Social Science Data Services. Findings: The results show that good working relationships, characterized by understanding each other’s vulnerability and willingness to learn from each other through shared experiences, are prerequisites for quality care. The healthcare providers further described ethical challenges as uncertainty and different understandings. Discussion: The results are discussed in the light of Lögstrup’s relational philosophy of ethics and the concepts of vulnerability, ethic responsibility, trust and openness of speech. Conclusion: The prerequisite for quality care for persons with dementia in a multicultural working environment is to create arenas for open discussions between the healthcare providers. Leadership is of great importance. (shrink)

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents’ perceptions of their child’s projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider (...) the appropriateness of parental refusal based upon an infant’s projected quality of life. (shrink)

Drawing on work done in the area of health services research, this article outlines a view of discourse analysis that approaches discourse as a co-accomplished process involving researcher and research-participant. Without losing sight of the analytical-critical-reflexive moments that have typified discourse analytical endeavours, this article explores a form of DA that moves from discourse as object to be collected and processed away from where it is practised, towards discourse as dynamically emerging reality shared by practitioner-participants and researchers, and as flexible (...) means to intervene in the quality and safety of care practices. The article begins with highlighting the productive potential of discourse research in health. The ethics informing this mode of DA, the article goes on to explain, is interested and trustful ‘entanglement’ with those who populate this field of practice and structure it with discourse. Elsewhere referred to as ‘experience-based enquiry’, the initiative to reframe discourse research as a mode of intervention involves keeping practitioners’ interpretations and analysts’ questions, critiques and conclusions in tension. The article argues that this approach capitalizes on the intrinsically reflexive, dialogic and emergent nature of discourse. To illustrate these issues, the article presents two case studies drawn from recent projects that have manifested these researcher and practitioner-participant dynamics. The article concludes that, as emergent practice, the analysis of discourse benefits from entanglement with the people and the contexts where discourse is produced. Here, analysis vacillates between a feedback device that enables both research participants and researchers to re-appraise their and each other’s practices, and a knowledge production device that generalizes about these practices and the changes to these practices that result from the research. (shrink)

Coercion in mental health care gives rise to many ethical challenges. Many countries have recently implemented state policy programs or development projects aiming to reduce coercive practices and improve their quality. Few studies have explored the possible role of ethics in such initiatives. This study adds to this subject by exploring health professionals’ descriptions of their ethical challenges and strategies in everyday life to ensure morally justified coercion and best practices. Seven semi-structured telephone interviews were carried out in (...) 2012 with key informants in charge of central development projects and quality-assurance work in mental health services in Norway. No facilities used formal clinical ethics support. However, the informants described five areas in which ethics was of importance: moral concerns as implicit parts of local quality improvement initiatives; moral uneasiness and idealism as a motivational source of change; creating a normative basis for development work; value-based leadership; and increased staff reflexivity on coercive practices. The study shows that coercion entails both individual and institutional ethical aspects. Thus, various kinds of moral deliberation and ethics support could contribute to addressing coercion challenges by offering more systematic ways of dealing with moral concerns. However, more strategic use of implicit and institutional ethics is also needed. (shrink)

The aim of this study was interpret the existential construct of family caring following Acute Coronary Syndrome. Family support is known to have a positive impact on recovery and adjustment after cardiac events. Few studies provide philosophically-based, interpretative explorations of carer experience following a spouse’s ischaemic event. As carer experiences, behaviours and meaning-making may impact on the quality of the support they provide to patients, further understanding could improve both patient outcomes and family experience. Fourteen spouses of people experiencing (...) Acute Coronary Syndrome in Sydney, Australia were engaged in a single, semi-structured interview. Interviews were audio-recorded and transcribed verbatim. Data were analysed using hermeneutic interpretation within a Heideggerian phenomenological framework. Acute Coronary Syndrome disrupts lived temporality, and the projected potential for carers’ being-alongside. Carers experienced an existential uncertainty that arose from difficulty in diagnosis, and situated fear as an attuned, being-towards-death. They constructed protective strategies to insulate their partner and themselves from further stress and risk, however, unclear boundaries for protection heightened carer anxiety. The existential structure of care included one of two possible Heideggerian modes: leaping-in care was a dominating mode that required a high level of carer vigilance; leaping-ahead care was a metaphorical walking alongside, as carers gave back control, freeing opportunities for the person to ‘own’ care. Supporting carers through the intensive phase of leaping-in care, and equipping them for informed leaping-ahead care should be a focus in both the acute and post-discharge care phases. (shrink)

With places at nursery school promised for every child above the age of four, this book raises the stakes by looking at the quality of what is provided, and how that compares to what should be provided. Beyond Quality In Early Childhood Education and Care challenges received wisdom and the tendency to reduce philosophical issues of value to purely technical issues of measurement and management. In its place, it offers alternative ways of understanding early childhood, early childhood (...) institutions and pedagogical work. The book places issues of early childhood into a global context and relates them to writers from many fields. Drawing on work with aboriginal peoples in Canada, on the experience of Reggio-Emilia in Italy and on a project in Stockholm inspired by Reggio, the book considers the implications of these alternative ways of understanding, for practice and a reconceptualization of early childhood education and care. (shrink)

The Dartmouth Institute for Health Policy and Clinical Practice Atlas Project found “staggering variations” in the quality and quantity of end-of-life care provided to Medicare patients with severe chronic illness across the United States. Particularly concerning is the finding that more care is provided to patients who live in “high-supply” areas, irrespective of the effectiveness of care, and that more care often equaled inappropriate care that increased patients’ suffering at the end of life. Patients (...) in “lower supply” areas typically received better, more appropriate levels of care and reported higher levels of satisfaction with the care they received. (shrink)

What this book is about -- Theoretical perspectives : modernity and postmodernity, power and ethics -- Constructing early childhood institution : what do we think it is? -- Constructing the early childhood institution : what do we think they are for? -- Beyond the discourse of quality to the discourse of meaning making -- The stockholm project : constructing a pedagogy that speaks in the voice of the child, the pedagogue and the parent -- Pedagogical documentation : a practice (...) for reflection and democracy -- Minority directions in the majority world : threats and possibilities. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of (...) consent and informed consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

While a circular economy (CE) paradigm shift has gained significant momentum among academics, practitioners, and policymakers, theory regarding its social aspects remains scant, especially theory based on an ethical, micro-level perspective. Circular consumption, referring to those consumption practices that aim to extend the lifetimes of objects and materials, involves ethical considerations. However, everyday circular consumption and its ethics have not gained a foothold in the CE literature. This article builds on the existing circular consumption literature by drawing insights from the (...) posthuman feminist theorising of care, shifting the focus of care from humans to the complex relations between humans and nonhumans and conceptualising circular consumption practices as matters of care. This conceptualisation, which follows a thinking-with-theory approach, is based on empirical material constructed in two research projects focusing on frontrunner consumers in terms of circular consumption in Finland: food waste reduction and circular clothing consumption. We identify circular consumption as care by introducing three distinct perspectives: care as tinkering, care as affective practices, and care as ethico-political action. We show that approaching circular consumption practices as matters of care, while not always easy or straightforward, is an attempt to make consumption better: more attentive, inclusive, durable, and enjoyable. Our findings emphasise the interconnected nature of circular practices, the constant performativity of circular consumption, and nonhumans as crucial stakeholders in care relations. Consequently, we offer an alternative to technocentric CE perspectives and a way to promote a sustainable world through care. (shrink)

BackgroundHIV prevention research in resource-limited countries is associated with a variety of ethical dilemmas. Key amongst these is the question of what constitutes an appropriate standard of health care (SoC) for participants in HIV prevention trials. This paper describes a community-focused approach to develop a locally-appropriate SoC in the context of a phase III vaginal microbicide trial in Mwanza City, northwest Tanzania.MethodsA mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and (...) modern bars, restaurants, hotels and guesthouses has been established in 10 city wards. Wards were divided into geographical clusters and community representatives elected at cluster and ward level. A city-level Community Advisory Committee (CAC) with representatives from each ward has been established. Workshops and community meetings at ward and city-level have explored project-related concerns using tools adapted from participatory learning and action techniques e.g. chapati diagrams, pair-wise ranking. Secondary stakeholders representing local public-sector and non-governmental health and social care providers have formed a trial Stakeholders' Advisory Group (SAG), which includes two CAC representatives.ResultsKey recommendations from participatory community workshops, CAC and SAG meetings conducted in the first year of the trial relate to the quality and range of clinic services provided at study clinics as well as broader standard of care issues. Recommendations have included streamlining clinic services to reduce waiting times, expanding services to include the children and spouses of participants and providing care for common local conditions such as malaria. Participants, community representatives and stakeholders felt there was an ethical obligation to ensure effective access to antiretroviral drugs and to provide supportive community-based care for women identified as HIV positive during the trial. This obligation includes ensuring sustainable, post-trial access to these services. Post-trial access to an effective vaginal microbicide was also felt to be a moral imperative.ConclusionParticipatory methodologies enabled effective partnerships between researchers, participant representatives and community stakeholders to be developed and facilitated local dialogue and consensus on what constitutes a locally-appropriate standard of care in the context of a vaginal microbicide trial in this setting.Trial registrationCurrent Controlled Trials ISRCTN64716212. (shrink)

Palliative care seeks to improve the quality of life for patients suffering from the impact of life‐limiting illnesses. Palliative care encompasses but is more than end‐of‐life care, which is defined as care during the final hours/days/weeks of life. Although palliative care policies increasingly require all healthcare professionals to have at least basic or non‐specialist skills in palliative care, international evidence suggests there are difficulties in realising such policies. This study reports on an action (...) research project aimed at developing respiratory nursing practice to address the palliative care needs of patients with advanced chronic obstructive pulmonary disease (COPD). The findings suggest that interlevel dynamics at individual, team, interdepartmental and organisational levels are an important factor in the capacity of respiratory nurses to embed non‐specialist palliative care in their practice. At best, current efforts to embed palliative care in everyday practice may improve end‐of‐life care in the final hours/days/weeks of life. However, embedding palliative care in everyday practice requires a more fundamental shift in the organisation of care. (shrink)

The level of medical care to patients and the success of the implementation of the national project "Health" depend on the health status and doctor's professionalism. Modern healthcare reform is being implemented by optimizing costs, merging medical organizations, closing ineffective hospitals, expanding the use of high-tech care and informatization of the doctor's activities. All this makes it necessary to assess the health of doctors. Scientists have studied the quality of life and identified the professional burnout of doctors (...) in children's clinics in different age groups. Primary care pediatricians have a higher quality of life score when compared to the standard [1]. However, all groups have a high level of professional burnout. The pre-retirement group of doctors has more unfavorable profile. They are highly professional specialists but may experience emotional discomfort because the pension system has been reformed. This situation requires the introduction of preventive work with doctors of this age as a group with great potential and capable of professional longevity. (shrink)

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

Introduction Quality improvement is the systematic seeking of improvements in care and experience. This discussion paper will explore how the principles of good clinical care and the established ethical frameworks for research can help guide its practice, using examples from palliative care. Quality improvement in palliative care Palliative care is well positioned to be at the vanguard of quality improvement in healthcare. But it holds ethical particularities which require specific considerations, that are (...) helpful for other specialities. The experiences of two improvement activities in palliative care, the Liverpool Care Pathway and Do Not Attempt Resuscitation status reviews, illustrate potential dangers of QI. Implications for ethical practice Recommendations for ethically sound quality improvement projects in palliative care include paying attention to the burden of time, viewing informed consent as a tool, monitoring for vulnerability and coercion and transparency in the use of data. The ethics and practices in clinical encounters provide a framework for approaching consent and protecting those with palliative care needs who are deemed as vulnerable. It is explicit in palliative care that time and energy are precious and finite resources. These must be valued and respected in any quality improvement projects. Respect for beneficence and autonomy is essential to avoid coercion and for any project to be ethically sound. Conclusion Quality improvement processes are an integral part of good healthcare practices. High ethical standards, a supportive culture, transparency and candour are needed for the promotion and sustainability of quality improvement in palliative care. (shrink)

BackgroundVarious forms of Clinical Ethics Support (CES) have been developed in health care organizations. Over the past years, increasing attention has been paid to the question of how to foster the quality of ethics support. In the Netherlands, a CES quality assessment project based on a responsive evaluation design has been implemented. CES practitioners themselves reflected upon the quality of ethics support within each other’s health care organizations. This study presents a qualitative evaluation of this (...) Responsive Quality Assessment (RQA) project.MethodsCES practitioners’ experiences with and perspectives on the RQA project were collected by means of ten semi-structured interviews. Both the data collection and the qualitative data analysis followed a stepwise approach, including continuous peer review and careful documentation of the decisions.ResultsThe main findings illustrate the relevance of the RQA with regard to fostering the quality of CES by connecting to context specific issues, such as gaining support from upper management and to solidify CES services within health care organizations. Based on their participation in the RQA, CES practitioners perceived a number of changes regarding CES in Dutch health care organizations after the RQA: acknowledgement of the relevance of CES for the quality of care; CES practices being more formalized; inspiration for developing new CES-related activities and more self-reflection on existing CES practices.ConclusionsThe evaluation of the RQA shows that this method facilitates an open learning process by actively involving CES practitioners and their concrete practices. Lessons learned include that “servant leadership” and more intensive guidance of RQA participants may help to further enhance both the critical dimension and the learning process within RQA. (shrink)

Definition of the problem Interprofessional learning of nursing trainees and medical students offers numerous opportunities for future cooperation aiming to provide high-quality care for patients. Arguments Expert panels, therefore, demand early integration of interprofessional teaching and learning structures in order to be able to achieve effective and sustainable improvements in practice. In Germany, interprofessional learning formats are increasingly used in undergraduate education of the two professions in selected—compulsory and optional—themes and courses. Conclusion So far, the field of health (...) care ethics has scarcely been taken into consideration. The article examines the situation of interprofessional ethics teaching in Germany and highlights its opportunities and limitations against the background of a pilot project. (shrink)

The leading scholars represented in _Politics, Philosophy, Writing_ examine six key Platonic dialogues and the most important of the epistles, moving from Plato's most public or political writings to his most philosophical. The collection is intended to demonstrate the unity of Plato's concerns, the literary quality of his writing, and the integral relation of form and content in his work. Taken together, these essays show the consistency of Plato's understanding of the political art, the art of writing, and the (...) philosophical life. Studies emphasizing the unity of Plato's lifework have given way in recent scholarship to specialized and overspecialized examinations of individual dialogues. While each of the contributors to _Politics, Philosophy, Writing_ studies one text, his or her work is oriented toward illuminating the whole of Plato's project. Each of the essays is an innovative contribution to scholarship on its topic; as a collection, they constitute a unique reading of Plato's political philosophy. Plato scholars have generally divided themselves into two camps: those who concentrate on the analytic or logical aspects of the dialogues, and those who concentrate on the literary-critical features. In one camp are the philologists and classicists, and in the other, the writers of inventive interpretive commentaries. By avoiding distinctions between Plato the poet and Plato the philosopher, _Politics, Philosophy, Writing_ allows a deeper exploration of the comprehensiveness of Plato's theoretical vision and illuminates the lasting challenge of his understanding of the human condition. (shrink)

This essay examines a special program developed by the international Canadian mining firm, Placer Dome, to help recently laid-off workers find remunerative work in southern Africa. Shortly after it bought a 50% interest in the Deep South gold mine in South Africa, the mine laid off nearly 2600 workers. The firm gave redundant miners token serverance pay and offered them opportunity to participate in training and counseling services at the mine site. Overwhelmingly, the miners came from homes all over southern (...) Africa at great distance from the mine to which homes they chose to return. In addition, many had become ill from the HIV virus. Placer Dome soon realized that something more was required, given the very high rates of unemployment in the region. After securing grants from USAID and CIDA, and working with NGOs representing both the unions and mining companies in South Africa, the firm developed Project CARE. The project contacted workers where they lived and offered them or another proxy member of their households a variety of training, coaching, and consultative services. Within 2 years 65% of those contacted had either found new employment or started their own business. The project helped those households with HIV-affected ex-miners care for their affected family members. While describing the case, the essay raises more general ethical questions about the responsibilities of mining firms in particular for their redundant workers. (shrink)

Background: A total of 71,000 people in Norway suffer from some form of dementia in 2013, of whom approximately 30,000 are in nursing homes. Several studies focus on the experiences of those who have close relatives and who are staying in a nursing home. Results show that a greater focus on cooperation between nursing staff and relatives is a central prerequisite for an increased level of care. Benefits of developing systematic collaboration practices include relief for nursing staff, less stress, (...) and greater mutual understanding. Going through studies focusing on the experiences of nursing home patients’ relatives, negative experiences are in the majority. In this study, relatives are invited to share positive experiences regarding the care of their loved ones; a slightly different perspective, in other words. Aim: The aim of the study is to investigate relatives of persons with dementia’s experiences with quality care in nursing homes. Method: The study is a part of a larger project called Hospice values in the care for persons with dementia and is based on a qualitative design where data are generated through narrative interviews. The chosen method of analysis is the phenomenological–hermeneutical method for the study of lived experiences. Participants and research context: Participants in the project were eight relatives of persons with dementia who were living in nursing homes, long-term residences. The sampling was targeted, enrolment happened through collective invitation. All relatives interested were included. Ethical considerations: The Norwegian Regional Ethics Committee and the Norwegian Social Science Data Services approve the study. Findings: Findings show that relatives have certain expectations as to how their loved ones ought to be met and looked after at the nursing home. The results show that in those cases where the expectations were met, the relatives’ experiences were associated with engagement, inclusion and a good atmosphere. When the expectations were not met, the relatives experienced powerlessness, distrust and guilt. Discussion: The results are discussed considering the concepts of trust, power and asymmetry. Conclusion: When asked about experiences with quality care, the relatives spoke both of expectations met and of expectations not met. Results in this study are important knowledge for developing units where performing quality care is the overall aim. (shrink)

Despite having paved the way for face, womb and penis transplants, hand transplantation today remains a small hybrid of reconstructive microsurgery and transplant immunology. An exceptionally limited patient population internationally complicates medical researchers’ efforts to parse outcomes “objectively.” Presumed functional and psychosocial benefits of gaining a transplant hand must be weighed in both patient decisions and bioethical discussions against the difficulty of adhering to post-transplant medications, the physical demands of hand transplant recovery on the patient, and the serious long-term health (...) risks of immunosuppressant drugs. This paper relates five narratives of hand transplantation drawn from an oral history project to show how narrative methods can and should inform ethical evaluations and the clinical process of hand transplantation. The interviews with patients and their partners analyzed here lead us to suggest that qualitative accounts of patient experiences should be used to complement clinical case studies reported in medical journals and to help develop instruments to assess outcomes more systematically. (shrink)

As the quality movement in health care now enters its fourth decade, the language of quality is ubiquitous. Practitioners, organizations, and government agencies alike vociferously testify their commitments to quality and accept numerous forms of governance aimed at improving quality of care. Remarkably, the powerful phrase ‘‘quality of care’’ is rarely defined in the health care literature. Instead it operates as an accepted and assumed goal worth pursuing. The status of evidence-based (...) medicine, for instance, hinges on its ability to improve quality of care, and efforts are made by both proponents and detractors to unpack the contents and outcomes of evidence-based practice while the contents of ‘‘quality of care’’ are presumed to be understood. Because the goals of medicine are far from obvious, this paper investigates the neglected term, ‘‘quality of care,’’ in an effort to understand what it is that health care practices are so uncritically assumed to be striving for. Finding lack of consensus on the terminology in the quality literature, I propose that the term operates rhetorically by way of persuasive appeal (and lack of descriptive meaning). Unsatisfied that ‘‘quality of care’’ operates as a mere buzzword in morally contentious debates over resource allocation and duties of care, I implore health care communities to go beyond mere commitments to quality and, instead, to focus attention on the difficult task of specifying what counts as quality care within an economically constrained health care system. (shrink)

The cost-effectiveness of 24-hour care makes it a major source of support for elderly people in need of home-based care in Austria. Language barriers, feelings of isolation when living with chronically ill people and a lack of adequate training and quality control create stressful working conditions for 24-hour caregivers in Austria, who mainly come from Slovakia, Hungary and Romania. The challenges not only affect the 24-hour caregivers themselves but also their clients, relatives and registered care agency (...) nurses in care settings. The aim of the qualitative study was to assess user needs in order to develop an app to improve working conditions and quality assurance in 24-hour home-care. The study consisted of guided interviews, focus group and cultural probes and 45 interviewees. The collected data were analyzed using Kuckartz’s method of content structuring qualitative content analysis. The main results show that 24-hour caregivers predominantly require information about common geriatric diseases and the law on 24-hour care. Additionally, medical emergencies can cause insecurities, which creates high interest in professional emergency management skills. Clients and relatives are especially interested in 24-hour caregivers having better German language skills. Care agencies and registered nurses would particularly welcome electronic care documentation to ensure traceability of the activities and measures taken. The study points to the need for a digital tool that would meet demand for an appropriate assistance system for 24-hour home-care that complies with the AAL requirements of the aligned project. Therefore, the intended software solution meets challenges in 24-hour home-care for 24-hour caregivers, persons in need of care, their relatives and professionals involved in the 24-hour care setting. (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.

BackgroundInternationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued.MethodsThe article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are reported, characterizing the scope, activities and organization of the ethics (...) activities in the Norwegian municipalities and the ethical topics addressed.ResultsOne hundred and thirty-seven municipal contact persons answered the first survey, whereas 217 ethics facilitators from 48 municipalities responded to the second. The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions whilst seldom reaching others. Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation.ConclusionsThe Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large scale implementation of CES structures for the municipal health and care services is complex, yet feasible. (shrink)

Recently, moral deliberation within care institutions is gaining more attention in medical ethics. Ongoing dialogues about ethical issues are considered as a vehicle for quality improvement of health care practices. The rise of ethical conversation methods can be understood against the broader development within medical ethics in which interaction and dialogue are seen as alternatives for both theoretical or individual reflection on ethical questions. In other disciplines, intersubjectivity is also seen as a way to handle practical problems, (...) and methodologies have emerged to deal with dynamic processes of practice improvement. An example is responsive evaluation. In this article we investigate the relationship between moral deliberation and responsive evaluation, describe their common basis in dialogical ethics and pragmatic hermeneutics, and explore the relevance of both for improving the quality of care. The synergy between the approaches is illustrated by a case example in which both play a distinct and complementary role. It concerns the implementation of quality criteria for coercion in Dutch psychiatry. (shrink)

This article considers the moral notion of care in the context of Quality of Care discourses. Whilst care has clear normative implications for the delivery of health care it is less clear how Quality of Care, something that is centrally involved in the governance of UK health care, relates to practice.

Background Moral distress is a common challenge among professional nurses when caring for their patients, especially when they need to make rapid decisions. Therefore, leaving moral distress unconsidered may jeopardize patient quality of care, safety, and satisfaction. Aim To estimate moral distress among nurses. Methods This systematic review and meta-analysis conducted systematic search in Scopus, PubMed, ProQuest, ISI Web of Knowledge, and PsycInfo up to end of February 2022. Methodological quality of included studies was assessed using the (...) Newcastle Ottawa checklist. Data from included studies were pooled by meta-analysis with random effect model in STATA software version 14. The selected key measure was mean score of moral distress total score with its’ 95% Confidence Interval was reported. Subgroup analyses and meta-regressions were conducted to identify possible sources of heterogeneity and potentially influencing variables on moral distress. Funnel plots and Begg’s Tests were used to assess publication bias. The Jackknife method was used for sensitivity analysis. Ethical consideration The protocol of this project was registered in the PROSPERO database under decree code of CRD42021267773. Results Eighty-six manuscripts with 19,537 participants from 21 countries were included. The pooled estimated mean score of moral distress was 2.55 on a 0–10 scale [95% Confidence Interval: 2.27–2.84, I2: 98.4%, Tau2:0.94]. Publication bias and small study effect was ruled out. Moral distress significantly decreased in the COVID-19 pandemic versus before. Nurses working in developing countries experienced higher level of moral distress compared to their counterparts in developed countries. Nurses' workplace (e.g., hospital ward) was not linked to severity of moral disturbance. Conclusion The results of the study showed a low level of pooled estimated score for moral distress. Although the score of moral distress was not high, nurses working in developing countries reported higher levels of moral distress than those working in developed countries. Therefore, it is necessary that future studies focus on creating a supportive environment in hospitals and medical centers for nurses to reduce moral distress and improve healthcare. (shrink)

The Institute of Medicine reporting on the quality of health care in America recommends six aims for achieving the health care system we could have. Together with the Institute for Healthcare Improvement Triple Aim initiative, a framework has emerged to challenge providers, educators, and policymakers to remake the health care system according to specific objectives: to provide care that is safe, effective, patient-centered, timely, efficient, and equitable to more people at a price we can afford. (...) Complicating this mission of better prevention and better care at a lower cost is a daunting demographic: January of 2011 marked the month and year that the first of the baby boomers turned 65. The U.S. Census Bureau in May 2010 projected the number of Americans of this age and over to reach 88 million by 2050, more than double the current figure of 40.2 million. Parekh and Barton forecast in stark detail what it will be like to address these burgeoning numbers of older Americans with comorbidities, including the fact that over 20% of the population currently experiences at least two chronic medical conditions. (shrink)

In this paper we set out to examine thearguments for and against the claim thatEvidence-Based Medicine (EBM) will improve thequality of care. In particular, we examine thefollowing issues.

This article discusses ethical issues which are raised as a result of the introduction of economic evidence in mental health care in order to rationalise clinical practice. Cost effectiveness studies and guidelines based on such studies are often seen as impartial, neutral instruments which try to reduce the influence of non-scientific factors. However, such rationalising instruments often hide normative assumptions about the goals of treatment, the selection of treatments, the role of the patient, and the just distribution of scarce (...) resources. These issues are dealt with in the context of increased control over clinical practice by third parties. In particular, health insurers have a great interest in economic evidence in clinical care settings in order to control access to and quality of health care. The authors conclude that guideline setting and cost effectiveness analysis may be seen as important instruments for making choices in health care, including mental health care, but that such an approach should always go hand in hand with a social and political debate about the goals of medicine and health care. This article is partly based on the results of a research project on the normative aspects of guideline setting in psychiatry and cardiology which was conducted under the guidance of the Royal Dutch Medical Association. (shrink)

How effectively communities of scientists come together and co-operate is crucial both to the quality of research outputs and to the extent to which such outputs integrate insights, data and methods from a variety of fields, laboratories and locations around the globe. This essay focuses on the ensemble of material and social conditions that makes it possible for a short-term collaboration, set up to accomplish a specific task, to give rise to relatively stable communities of researchers. We refer to (...) these distinctive features as repertoires, and investigate their development and implementation across three examples of collaborative research in the life sciences. We conclude that whether a particular project ends up fostering the emergence of a resilient research community is partly determined by the degree of attention and care devoted by researchers to material and social elements beyond the specific research questions under consideration. (shrink)

Infants, children and adolescents with life-limiting and life-threatening disease need long-term care that may change according to disease’s natural history. With the primary goal of quality of life, the psychologist of pediatric palliative care network deals with a large variety of issues. Little consideration has been given to the variety of intervention areas of psychology in PPC that concern the whole life span of the patient and family. The PPC network is composed by a multidisciplinary team of (...) palliative care specialists that intervenes at home, in the hospital and in every place where the patient is living. The network coordinates different public health services to respond to clinical, psychosocial and spiritual needs. In these scenarios, the psychological need is not a single event but a moment inserted in the complexity of the child’s needs. This retrospective monocentric project consists of an analysis of characteristics of psychological interventions in our PPC service. The time frame taken into consideration is 2019–2020, analyzing the clinical records of 186 patients of Pediatric Palliative Care and Pain Service of Veneto Region. The areas that emerged in the analysis show how the intervention of the psychologist in PPC does not concern only end-of-life, but a series of topics that are significant for the family to guarantee psycho-social wellbeing oriented toward the best quality of life. In conclusion, these different topics highlight the complexity of the child and family experience. This variety must be taken into consideration, the psychologist must increase holistic support with a dedicated skills curriculum. (shrink)

Background: To provide care with high quality, nurses face a number of moral issues requiring them to have moral abilities in professional performance. Moral sensitivity is the first step in moral performance. However, its relation to the quality of care patients receive is controversial. Research objective: This study aims to determine the relationship between the moral sensitivity of nurses and the quality of care received by patients in the medical wards. Research design: A descriptive (...) correlational study using validated tools, including Moral Sensitivity Questionnaire and the Quality Patient Quality Scale. Participants and research context: In total, 198 nurses and 198 patients in 17 medical wards of hospitals affiliated with Tabriz University of Medical Sciences, Iran. Ethical considerations: The study was reviewed and approved by the Ethics Committee of Tabriz University of Medical Sciences. Findings: The mean values of nurses’ moral sensitivity and nurses’ quality care were 136.47 ± 13.30 and 196.36 ± 44.10, respectively. There was no significant relationship between the patient care quality and nurses’ moral sensitivity ( r = −.14, p =.5). However, there was a significant inverse relationship between the dimension of “Experiencing moral conflicts” and the overall score of quality care ( r = −.50, p =.04), the dimensions of “psychosocial ( r = −.50, p =.04)” and “physical ( r = −.50, p =.03).” Conclusion: Considering the significant inverse relationship between the score of patient quality care and the dimension of moral conflict experience, it seems when nurses make moral decisions, they experience a conflict between personal and professional values in their careers and thus experience moral tension. If this tension is not resolved properly, it can provide a way for them to distance themselves from patients, thereby making nurses indifferent to moral care. (shrink)

BackgroundAs part of the research project “End-of-life Communication in Nursing Homes. Patient Preferences and Participation”, we have studied how Advance Care Planning is carried out in eight Norwegian nursing homes. The concept of ACP is a process for improving patient autonomy and communication in the context of progressive illness, anticipated deterioration and end-of-life care. While an individualistic autonomy based attitude is at the fore in most studies on ACP, there is a lack of empirical studies on how family (...) members’ participation and involvement in ACP- conversations may promote nursing home patients’ participation in decisions on future treatment and end-of-life care. Based on empirical data and family ethics perspectives, the purpose of this study is to add insights to the complexity of ACP-conversations and illuminate how a family ethics perspective may improve the quality of the ACP and promote nursing home patients’ participation in advance care planning.MethodsParticipant observations of ACP-conversations in eight nursing homes. The observations were followed by interviews with patients and relatives together on how they experienced being part of the conversation, and expressing their views on future medical treatment, hospitalization and end-of-life issues.ResultsWe found that the way nursing home patients and relatives are connected and related to each other, constitutes an intertwined unit. Further, we found that relatives’ involvement and participation in ACP- conversations is significant to uncover, and give the nursing home staff insight into, what is important in the nursing home patient’s life at the time. The third analytical theme is patients’ and relatives’ shared experiences of the dying and death of others. Drawing on past experiences can be a way of introducing or talking about death.ConclusionsAn individual autonomy approach in advance care planning should be complemented with a family ethics approach. To be open to family ethics when planning for the patient’s future in the nursing home is to be open to diversity and nuances and to the significance of the patient’s former life and experiences. (shrink)

Background and PurposeMany critically ill patients in intensive care units (ICUs) are unable to communicate their wishes about goals of care, particularly about the use of life-sustaining treatments. Surrogates and clinicians struggle with medical decisions because of a lack of clarity regarding patients’ preferences, leading to prolonged hospitalizations and increased costs. This project focused on the development and implementation of a tool to facilitate a better communication process by (1) assuring the early identification of a surrogate if indicated (...) on admission and (2) clarifying the decision-making standards that the surrogate was to use when participating in decision making. Before introducing the tool into the admissions routine, the staff were educated about its use and value to the decision-making process.Project and MethodsThe study was to determine if early use of a simple method of identifying a patient’s surrogate and treatment preferences might impact length of stay (LOS) and total hospital charges. A pre- and post-intervention study design was used. Nurses completed the surrogacy information tool for all patients upon admission to the neuroscience ICU. Subjects (total N=203) were critically ill patients who had been on a mechanical ventilator for 96 hours or longer, or in the ICU for seven days or longer. The project included staff education on biomedical ethics, critical communication skills, early identification of families and staff in crisis, and use of a simple tool to document patients’ surrogates and previously expressed care wishes. Data on hospital LOS and hospital charges were collected through a retrospective review of medical records for similar four-month time frames pre- and post-implementation of the assessment tool.ResultsSignificant differences were found between pre- and post-groups in terms of hospital LOS (F=6.39, p=.01) and total hospital charges (F=7.03, p=.009).ConclusionsProject findings indicate that the use of a simple admission assessment tool, supported by staff education about its completion, use, and available resources, can decrease LOS and lower total hospital charges. The reasons for the difference between the pre- and post-intervention groups remain unclear. Further research is needed to evaluate if the quality of communications between patients, their legally authorized representatives, and clinicians—as suggested in the literature—may have played a role in decreasing LOS and total hospital charges. (shrink)

Telemedicine is a complex field including various applications and target groups. Especially telehealthcare is seen by many as a means to revolutionize medicine. It gives patients the opportunity to take charge of their own health by using self-tracking devices and allows health professionals to treat patients from a distance. To some, this means an empowerment of patient autonomy as well as an improvement in the quality of care. Others state the dangers of depersonalization of medicine and the pathologization (...) of daily life. This paper examines the ethical implications of telehealthcare, focusing on patient autonomy and quality of care by analyzing metareviews, randomized controlled trials and narrative ethical analyses on the topic. As a result, we conclude that the technically enhanced encounter between patients and health professionals may mean an empowerment of patient autonomy when it goes along with a personal relationship based on trust, assistance and support. When it comes to the quality of care, telehealthcare may lead to an improvement as long it is adopted to the patient’s individual needs. (shrink)