Results for 'Guideline'

996 found
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  1. Submission guidelines.Submission Guidelines - 2014 - Archai: Revista de Estudos Sobre as Origens Do Pensamento Ocidental 12:205-207.
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  2. Submission guidelines.Guidelines Submission - 2014 - Archai: Revista de Estudos Sobre as Origens Do Pensamento Ocidental 13:179-181.
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  3. Ethical guidelines for COVID-19 tracing apps.Jessica Morley, Josh Cowls, Mariarosaria Taddeo & Luciano Floridi - 2020 - Nature 582:29–⁠31.
    Technologies to rapidly alert people when they have been in contact with someone carrying the coronavirus SARS-CoV-2 are part of a strategy to bring the pandemic under control. Currently, at least 47 contact-tracing apps are available globally. They are already in use in Australia, South Korea and Singapore, for instance. And many other governments are testing or considering them. Here we set out 16 questions to assess whether — and to what extent — a contact-tracing app is ethically justifiable.
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  4.  10
    Ventilators, Guidelines, Judgment, and Trust.Samuel Gorovitz - 2020 - Hastings Center Report 50 (3):5-6.
    Covid‐19 confronts us with tragic choices, in which every option is unacceptable. On the New York State Task Force on Life and the Law, I worked on guidelines for such situations. We did not envision the scale or character of Covid‐19. To minimize fear that the decisions made in these situations might be unfair, we all must know what guidelines or mandates inform them. Only with transparency about how decisions will be made, by whom, and according to what requirements can (...)
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  5.  92
    Consensus guidelines on analgesia and sedation in dying intensive care unit patients.Laura Hawryluck, William Harvey, Louise Lemieux-Charles & Peter Singer - 2002 - BMC Medical Ethics 3 (1):1-9.
    Background Intensivists must provide enough analgesia and sedation to ensure dying patients receive good palliative care. However, if it is perceived that too much is given, they risk prosecution for committing euthanasia. The goal of this study is to develop consensus guidelines on analgesia and sedation in dying intensive care unit patients that help distinguish palliative care from euthanasia. Methods Using the Delphi technique, panelists rated levels of agreement with statements describing how analgesics and sedatives should be given to dying (...)
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  6. Guidelines for writing definitions in ontologies.Selja Seppälä, Alan Ruttenberg & Barry Smith - 2017 - Ciência da Informação 46 (1): 73-88.
    Ontologies are being used increasingly to promote the reusability of scientific information by allowing heterogeneous data to be integrated under a common, normalized representation. Definitions play a central role in the use of ontologies both by humans and by computers. Textual definitions allow ontologists and data curators to understand the intended meaning of ontology terms and to use these terms in a consistent fashion across contexts. Logical definitions allow machines to check the integrity of ontologies and reason over data annotated (...)
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  7. Clinical guidelines as plans: An ontological theory.Anand Kumar, Barry Smith, Domenica Pisanelli, Aldo Gangemi & Mario Stefanelli - 2006 - Methods of Information in Medicine 45 (2):204-210.
    Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various levels (...)
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  8.  2
    Guidelines for Authors.- - - 2024 - Scientia et Fides 12 (1):269-274.
    The guidelines of _Scientia et Fides_ can be found on: https://www.chicagomanualofstyle.org/tools_citationguide/citation-guide-2.html or https://apcz.umk.pl/SetF/about/submissions.
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  9.  89
    Rethinking Guidelines for the Use of Palliative Sedation.Jeffrey T. Berger - 2010 - Hastings Center Report 40 (3):32-38.
    Current guidelines treat palliative sedation to unconsciousness as an effective medical treatment for terminally ill patients who need relief from severe symptoms, yet also restrict its use in ways that are extraordinary for medical treatments. A closer look at the kinds of cases in which palliative sedation is used suggests a way of adjusting the guidelines to resolve this seeming contradiction.
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  10.  12
    Ethical Guidelines for SARS-CoV-2 Digital Tracking and Tracing Systems.Jessica Morley, Josh Cowls, Mariarosaria Taddeo & Luciano Floridi - 2021 - In Josh Cowls & Jessica Morley (eds.), The 2020 Yearbook of the Digital Ethics Lab. Springer Verlag. pp. 89-95.
    The World Health Organisation declared COVID-19 a global pandemic on 11th March 2020, recognising that the underlying SARS-CoV-2 has caused the greatest global crisis since World War II. In this chapter, we present a framework to evaluate whether and to what extent the use of digital systems that track and/or trace potentially infected individuals is not only legal but also ethical.
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  11.  41
    Guidelines for training in the ethical conduct of scientific research.Dr Seymour J. Garte - 1995 - Science and Engineering Ethics 1 (1):59-70.
    Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...)
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  12.  21
    Clinical guidelines: ways ahead.C. W. R. Onion Md Mrcgp & T. Walley Md Frcp - 1998 - Journal of Evaluation in Clinical Practice 4 (4):287-293.
  13.  38
    Ethical guidelines for deliberately infecting volunteers with COVID-19.Adair D. Richards - 2020 - Journal of Medical Ethics 46 (8):502-504.
    Global fatalities related to COVID-19 are expected to be high in 2020–2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods—that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and (...)
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  14. Research guidelines for embryoids.Monika Piotrowska - 2021 - Journal of Medical Ethics 47 (12):e67-e67.
    Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they are nonetheless unworkable, (...)
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  15.  19
    Guidelines for open peer review implementation.Edit Görögh & Tony Ross-Hellauer - 2019 - Research Integrity and Peer Review 4 (1).
    Open peer review (OPR) is moving into the mainstream, but it is often poorly understood and surveys of researcher attitudes show important barriers to implementation. As more journals move to implement and experiment with the myriad of innovations covered by this term, there is a clear need for best practice guidelines to guide implementation. This brief article aims to address this knowledge gap, reporting work based on an interactive stakeholder workshop to create best-practice guidelines for editors and journals who wish (...)
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  16.  13
    Professional Guidelines for the Care of Extremely Premature Neonates: Clinical Reasoning versus Ethical Theory.Matthew J. Drago & H. Alexander Chen - 2023 - Journal of Clinical Ethics 34 (3):233-244.
    Professional statements guide neonatal resuscitation thresholds at the border of viability. A 2015 systematic review of international guidelines by Guillen et al. found considerable variability between statements’ clinical recommendations for infants at 23–24 weeks gestational age (GA). The authors concluded that differences in the type of data included were one potential source for differing resuscitation thresholds within this “ethical gray zone.” How statements present ethical considerations that support their recommendations, and how this may account for variability, has not been as (...)
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  17.  7
    Guidelines as governance: Critical reflections from a documentary analysis of guidelines to support user involvement in research.Susanne Stuhlfauth, Ingrid Ruud Knutsen & Ingrid Christina Foss - 2021 - Nursing Inquiry 28 (1):e12378.
    Although guidelines to regulate user involvement in research have been advocated and implemented for several years, literature still describes the process as challenging. In this qualitative study, we take a critical view on guidelines that are developed to regulate and govern the collaboration process of user involvement in research. We adapt a social constructivist view of guidelines and our aim is to explore how guidelines construct the perception of users and researchers and thus the process of involvement. Twenty‐two guidelines published (...)
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  18.  28
    Ethical guidelines for the use of artificial intelligence and the challenges from value conflicts.Thomas Søbirk Petersen - 2021 - Etikk I Praksis - Nordic Journal of Applied Ethics 1:25-40.
    The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages will also (...)
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  19.  24
    Guidelines for every person.Deborah C. Saltman - 1998 - Journal of Evaluation in Clinical Practice 4 (1):1-9.
  20.  10
    Ethics, Guidelines, Standards, and Policy: Telemedicine, COVID-19, and Broadening the Ethical Scope.Bonnie Kaplan - 2022 - Cambridge Quarterly of Healthcare Ethics 31 (1):105-118.
    The coronavirus crisis is causing considerable disruption and anguish. However, the COVID-19 pandemic and consequent explosion of telehealth services also provide an unparalleled opportunity to consider ethical, legal, and social issues beyond immediate needs. Ethicists, informaticians, and others can learn from experience, and evaluate information technology practices and evidence on which to base policy and standards, identify significant values and issues, and revise ethical guidelines. This paper builds on professional organizations’ guidelines and ELSI scholarship to develop emerging concerns illuminated by (...)
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  21.  30
    Guidelines for clinical Practice: What They Are and why They count.Kathleen N. Lohr - 1995 - Journal of Law, Medicine and Ethics 23 (1):49-56.
    Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work done since 1990 (...)
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  22.  26
    Guidelines for the reuse of ontology content.Michael Halper, Larisa N. Soldatova, Mathias Brochhausen, Fatima Sabiu Maikore, Christopher Ochs & Yehoshua Perl - 2023 - Applied ontology 18 (1):5-29.
    Reuse of elements from existing ontologies in the construction of new ontologies is a foundational principle in ontological design. It offers the benefits, among others, of consistency and interoperability between such knowledge structures as well as sharing resources. Reuse is widely found within important collections of established ontologies, such as BioPortal and the OBO Foundry. However, reuse comes with its own potential problems involving ontological commitment, granularity, and ambiguity. Guidelines are proposed to aid ontology developers and curators in their prospective (...)
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  23.  39
    Guidelines adherence and hypertension control at a tertiary hospital in Malaysia.Nafees Ahmad, Yahaya Hassan, Balamurugan Tangiisuran, Ong Loke Meng, Noorizan Abd Aziz, Fiaz‐ud‐Din Ahmad & Muhammad Atif - 2013 - Journal of Evaluation in Clinical Practice 19 (5):798-804.
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  24. Guidelines for theorizing about realization.Kevin Morris - 2010 - Southern Journal of Philosophy 48 (4):393-416.
    Realization can be roughly understood as a kind of role-playing, a relationship between a property that plays a role and a property characterized by that role. This rough sketch previously received only moderate elaboration; recently, however, several substantive theories of realization have been proposed. But are there any general constraints on a theory of realization? What is a theory of realization supposed to accomplish? I first argue that a view of realization is viable, in part, to the extent that physical (...)
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  25.  27
    Guidelines for Ethical Review of Qualitative Research.J. Walker, I. Holloway & S. Wheeler - 2005 - Research Ethics 1 (3):90-96.
    In recognition of the important ethical issues posed by qualitative research in health care, the authors present key questions to aid ethical review. The purpose is to assist lay and professional members of research ethics committees in their assessment of applications involving qualitative research methods and to inform researchers intending to submit such applications for ethical approval. For the benefit of those less familiar with this type of research, the authors include an overview of different types of qualitative research, together (...)
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  26.  47
    Guidelines for Teaching Cross-Cultural Clinical Ethics: Critiquing Ideology and Confronting Power in the Service of a Principles-Based Pedagogy.Fern Brunger - 2016 - Journal of Bioethical Inquiry 13 (1):117-132.
    This paper presents a pedagogical framework for teaching cross-cultural clinical ethics. The approach, offered at the intersection of anthropology and bioethics, is innovative in that it takes on the “social sciences versus bioethics” debate that has been ongoing in North America for three decades. The argument is made that this debate is flawed on both sides and, moreover, that the application of cross-cultural thinking to clinical ethics requires using the tools of the social sciences within a principles-based framework for clinical (...)
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  27.  12
    Guidelines for clinical Practice: What They Are and why They count.Kathleen N. Lohr - 1995 - Journal of Law, Medicine and Ethics 23 (1):49-56.
    Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work done since 1990 (...)
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  28.  9
    Ethical guidelines for a superintelligence.Ernest Davis - 2015 - Artificial Intelligence 220:121-124.
  29.  66
    Guidelines for value based management in kautilya's arthashastra.N. Siva Kumar & U. S. Rao - 1996 - Journal of Business Ethics 15 (4):415 - 423.
    The paper develops value based management guidelines from the famous Indian treatise on management, Kautilya's Arthashastra. Guidelines are given for individual components of a total framework in detail, which include guidelines for organizational philosophy, value based leadership, internal corporate culture, accomplishment of corporate purpose and feedback from stakeholders.
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  30.  18
    Towards guidelines for informed consent for prospective stem cell research.J. Greenberg, D. C. Smith, R. J. Burman, R. Ballo & S. H. Kidson - 2015 - South African Journal of Bioethics and Law 8 (2):46.
    Stem cell science is advancing at an unprecedented rate, with thousands of research papers being published every year and many clinical trials for a wide range of conditions underway as registered on ClinicalTrials.gov. This rapidly expanding and alluring field has brought with it ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not fit comfortably in the existing bioethical regulations and protocols. Keeping up with the ethical (...)
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  31.  62
    Professional guidelines on Decisions Relating to Cardiopulmonary Resuscitation: introduction.Gillian Romano-Critchley & Ann Sommerville - 2001 - Journal of Medical Ethics 27 (5):308-309.
    The context in which the British Medical Association first considered publishing specific guidelines on decisions about attempting cardiopulmonary resuscitation , in the early 1990s, needs to be remembered. At that time the subject was often seen as far too sensitive to be mentioned to patients. Many hospitals had no formal policy about how CPR decisions should be made, apart from an expectation that these were purely medical matters. Advance decision making about CPR, where it existed, appears to have been generally (...)
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  32.  9
    Practice Guidelines and Private Insurers.Christine W. Parker - 1995 - Journal of Law, Medicine and Ethics 23 (1):57-61.
    Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to an (...)
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  33.  10
    Practice Guidelines and Private Insurers.Christine W. Parker - 1995 - Journal of Law, Medicine and Ethics 23 (1):57-61.
    Practice guidelines are an increasingly relevant feature of health insurance. One hundred and seventy-eight million people in the United States have some form of private health insurance coverage; coverage for 150 million of them is employment-related. Traditionally, this coverage was provided by employers purchasing a group contract under which an insurance carrier provided indemnity coverage for employees—that is, the insurance company paid all usual, customary, and reasonable charges incurred by an employee for medical care, subject in some cases to an (...)
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  34.  27
    Guidelines to Prevent Malevolent Use of Biomedical Research.Shane K. Green, Sara Taub, Karine Morin & Daniel Higginson - 2006 - Cambridge Quarterly of Healthcare Ethics 15 (4):432-439.
    In February 1975, a group of leading scientists, physicians, and policymakers convened at Asilomar, California, to consider the safety of proceeding with recombinant DNA research. The excitement generated by the promise of this new technology was counterbalanced by concerns regarding dangers that might arise from it, including the potential for accidental release of genetically modified organisms into the environment. Guidelines developed at the conference to direct future research endeavors had several consequences. They permitted research to resume, bringing to an end (...)
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  35.  27
    Guidelines for IRB Review of International Collaborative Medical Research: A Proposal.Mary Terrell White - 1999 - Journal of Law, Medicine and Ethics 27 (1):87-94.
    The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local (...)
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  36.  25
    Ethical Guidelines for Use of Electronic Mail Between Patients and Physicians.Amy M. Bovi - 2003 - American Journal of Bioethics 3 (3):43-47.
    This Report examines the ethical implications of electronic communication, focusing on the use of electronic mail (e-mail), considers its impact on a previously established patient-physician relationship, and the limitations in using e-mail to create a new patient-physician relationship. In its recommendations, this report offers guidance to physicians who use electronic mail to communicate with patients and online users. These guidelines maintain that e-mail should not be used to establish a patient-physician relationship, but rather to supplement personal encounters. When using e-mail, (...)
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  37.  7
    Guidelines for conscientious objection in Spain: a proposal involving prerequisites and protocolized procedure.Pilar Pinto Pastor, Tamara Raquel Velasco Sanz, Andrés Santiago-Saez, Venktesh R. Ramnath & Benjamín Herreros - 2024 - Philosophy, Ethics, and Humanities in Medicine 19 (1):1-10.
    Healthcare professionals often face ethical conflicts and challenges related to decision-making that have necessitated consideration of the use of conscientious objection (CO). No current guidelines exist within Spain’s healthcare system regarding acceptable rationales for CO, the appropriate application of CO, or practical means to support healthcare professionals who wish to become conscientious objectors. As such, a procedural framework is needed that not only assures the appropriate use of CO by healthcare professionals but also demonstrates its ethical validity, legislative compliance through (...)
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  38.  42
    Guidelines for training in the ethical conduct of scientific research.Seymour J. Garte - 1995 - Science and Engineering Ethics 1 (1):59-70.
    Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...)
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  39. Some guidelines for the phenomenological analysis of interview data.Richard H. Hycner - 1985 - Human Studies 8 (3):279 - 303.
    This article explicates, in a concrete, step-by-step manner, some procedures that can be followed in phenomenologically analyzing interview data. It also addresses a number of issues that are raised in relation to phenomenological research.
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  40.  24
    Guidelines for IRB Review of International Collaborative Medical Research: A Proposal.Mary Terrell White - 1999 - Journal of Law, Medicine and Ethics 27 (1):87-94.
    The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local (...)
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  41.  10
    Practical guidelines to ameliorate the effects of internal and external deployments on the marriages of soldiers.Velile E. Mtshayisa & Rantoa Letšosa - 2019 - HTS Theological Studies 75 (4):1-7.
    This article critically looks at the challenges that are incumbent in the deployment of married soldiers who work for the South African National Defence Force. The SANDF previously deployed soldiers outside the borders of South Africa for a period of 6 months or less. But currently, the SANDF has a deployment period of 12 months. This period is twice that of the earlier period, which means that soldiers and their families have to spend 12 months apart from one another. This (...)
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  42. Guidelines on the Practice of Ethics Committees in Medical Research with Human Participants.[author unknown] - 2007
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  43.  26
    Guidelines for Appropriate Care: The Importance of Empirical Normative Analysis.Marc Berg, Ruud ter Meulen & Masja Van den Burg - 2001 - Health Care Analysis 9 (1):77-99.
    The Royal Dutch Medical Association recently completed a researchproject aimed at investigating how guidelines for `appropriatemedical care' should be construed. The project took as a startingpoint that explicit attention should be given to ethical andpolitical considerations in addition to data about costs andeffectiveness. In the project, two research groups set out todesign guidelines and cost-effectiveness analyses (CEAs) for twocircumscribed medical areas (angina pectoris and majordepression). Our third group was responsible for the normativeanalysis. We undertook an explorative, qualitative pilot study ofthe (...)
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  44.  34
    Finding guidelines on social change in the two-tiered narrative and diakonia in the Gospel of John.Gert Breed - 2015 - HTS Theological Studies 71 (2):01-08.
    It is shown in this article that the Gospel of John describes a battle between darkness and light, life and death, chaos and God’s new order. Although the certainty is given right at the beginning of the Gospel that the darkness will not overcome the light, God does not take the possibility of darkness away. Darkness in John is darkness of the mind, not seeing the light, not comprehending, not accepting and not believing the Word. The battle between light and (...)
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  45. Systemising Triage: COVID-19 Guidelines and Their Underlying Theories of Distributive Justice.Lukas J. Meier - 2022 - Medicine, Health Care and Philosophy 25 (4):703-714.
    The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since most (...)
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  46.  28
    Improved guideline adherence to pharmacotherapy of chronic systolic heart failure in general practice – results from a cluster‐randomized controlled trial of implementation of a clinical practice guideline.Frank Peters-Klimm, Thomas Müller-Tasch, Andrew Remppis, Joachim Szecsenyi & Dieter Schellberg - 2008 - Journal of Evaluation in Clinical Practice 14 (5):823-829.
  47.  20
    Ethical Guidelines for rTMS Research.Ronald M. Green, Alvaro Pascual-Leone & Eric M. Wasserman - 1997 - IRB: Ethics & Human Research 19 (2):1.
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  48.  44
    Guidelines for the development of an ethics safety net.Muel Kaptein - 2002 - Journal of Business Ethics 41 (3):217 - 234.
    Large organisations are especially advised to consider the possibility of an Ethics Helpdesk in which all employees and managers can report with all suspected cases of unethical conduct, critical comments, dilemmas and advice for which there is insufficient room within the organisational hierarchy. A helpdesk is a central contact point where it is decided who the most appropriate person is to dealing with a given case. The helpdesk model is characterised by low barriers in its easy accessibility, positive approach and (...)
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  49.  18
    Guidelines for Computational Modeling of Friendship.William F. Clocksin - 2023 - Zygon 58 (4):1045-1061.
    Humans participate in an immense variety of relationships with other persons and other entities: human and nonhuman, living and nonliving, tangible and intangible, real and imagined. Participation in relationships is considered a key benchmark of personhood. Some of these relationships, particularly friendships, involve close emotional attachments, and some friendships have been described since antiquity as spiritual in nature. Different types of friendship depend upon factors such as proximity, social formality, physical intimacy, information exchanged, and the costs and benefits of maintaining (...)
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  50.  16
    Proposed guidelines for the protection of vulnerable subjects in clinical trials: Protections for decisionally impaired subjects.Gordon D. MacFarlane, Mark C. Herzberg & Laure Campbell - 2015 - Clinical Ethics 10 (3):59-69.
    Current regulations and guidelines identify specific subject populations as vulnerable. Regulations and guidelines generally stipulate protections with regard to the process of informed consent. Recent clinical trials suggest that satisfying the legal requirements for additional safeguards may not protect subjects to the extent we may desire. We present proposed guidelines for the protection of decisionally impaired subjects throughout the course of the trial.
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