Search results for 'Clinical Protocols' (try it on Scholar)

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  1. R. Dal-Re, J. Espada & R. Ortega (1999). Performance of Research Ethics Committees in Spain. A Prospective Study of 100 Applications for Clinical Trial Protocols on Medicines. Journal of Medical Ethics 25 (3):268-273.score: 48.0
    OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had (...)
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  2. Brian Hurwitz (1995). Clinical Guidelines and the Law: Advice, Guidance or Regulation? Journal of Evaluation in Clinical Practice 1 (1):49-60.score: 42.0
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  3. Anna C. Mastroianni, Ruth R. Faden & Daniel D. Federman (eds.) (1994). Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. National Academy Press.score: 39.0
    Executive Summary There is a general perception that biomedical research has not given the same attention to the health problems of women that it has given ...
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  4. Daniel W. Fitzgerald, Angela Wasunna & Jean William Pape (forthcoming). Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols. Irb.score: 36.0
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  5. Frederick Grinnell (forthcoming). Endings of Clinical Research Protocols: Distinguishing Therapy From Research. Irb.score: 36.0
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  6. M. A. Sanchez-Gonzalez, B. Herreros, V. R. Ramnath, M. D. Martin, E. Pintor & L. Bishop (2014). Clinical Ethics Protocols in the Clinical Ethics Committees of Madrid. Journal of Medical Ethics 40 (3):205-208.score: 36.0
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  7. E. A. Waters (1997). Improving Clinical Effectiveness: A Practical Approach. Journal of Evaluation in Clinical Practice 3 (4):255-264.score: 36.0
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  8. Laura Vargas-Parada, Simon Kawa, Alberto Salazar, Juan Jose Mazon & Ana Flisser (2006). Informed Consent in Clinical Research at a General Hospital in Mexico: Opinions of the Investigators. Developing World Bioethics 6 (1):41-51.score: 33.0
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  9. Adnan A. Hyder & Salman A. Wali (2006). Informed Consent and Collaborative Research: Perspectives From the Developing World. Developing World Bioethics 6 (1):33–40.score: 30.0
    203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.
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  10. A. Stroustrup, S. Kornetsky & S. Joffe (2007). Knowledge of Regulations Governing Pediatric Research: A Pilot Study. Irb 30 (5):1-7.score: 30.0
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  11. Jill A. Fisher (2008). Institutional Mistrust in the Organization of Pharmaceutical Clinical Trials. Medicine, Health Care and Philosophy 11 (4):403-413.score: 27.0
    In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies (...)
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  12. I. H. Kunkler (1997). Variations in the Management of Cancer in the NHS: A Legitimate Cause for Concern? Journal of Evaluation in Clinical Practice 3 (3):173-177.score: 27.0
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  13. Norbert Steinkamp & Bert Gordijn (2003). Ethical Case Deliberation on the Ward. A Comparison of Four Methods. Medicine, Health Care and Philosophy 6 (3):235-246.score: 24.0
    The objective of this article is to analyse and compare four methods of ethical case deliberation. These include Clinical Pragmatism, The Nijmegen Method of ethical case deliberation, Hermeneutic dialogue, and Socratic dialogue. The origin of each method will be briefly sketched. Furthermore, the methods as well as the related protocols will be presented. Each method will then be evaluated against the background of those situations in which it is being used. The article aims to show that there is (...)
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  14. Sarah Chan, Ying-Kiat Zee, Gordon Jayson & John Harris (2011). 'Risky' Research and Participants' Interests: The Ethics of Phase 2C Clinical Trials. Clinical Ethics 6 (2):91-96.score: 24.0
    Biomedical research involving human participants is highly regulated and subject to stringent ethical requirements. Clinical research ethics, regulation and policy have tended to focus almost exclusively on the protection of participants' interests against harms that might result from taking part in research. Less consideration, however, has been given to the interests that patients may themselves have in research participation, even in trials that may be beyond the bounds of current clinical research practice. In this paper, we consider the (...)
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  15. Lyle C. Gurrin, Peter D. Sly & Paul R. Burton (2002). Using Imprecise Probabilities to Address the Questions of Inference and Decision in Randomized Clinical Trials. Journal of Evaluation in Clinical Practice 8 (2):255-268.score: 24.0
    Randomized controlled clinical trials play an important role in the development of new medical therapies. There is, however, an ethical issue surrounding the use of randomized treatment allocation when the patient is suffering from a life threatening condition and requires immediate treatment. Such patients can only benefit from the treatment they actually receive and not from the alternative therapy, even if it ultimately proves to be superior. We discuss a novel new way to analyse data from such clinical (...)
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  16. J. Hughes & T. Walker (2009). The Rule of Rescue in Clinical Practice. Clinical Ethics 4 (1):50-54.score: 21.0
    People often have a strong intuitive sense that we ought to rescue those in serious need, even in cases where we could produce better outcomes by acting in other ways. It has become common in such cases to refer to this as the Rule of Rescue. Within the medical field this rule has predominantly been discussed in relation to decisions about whether to fund particular treatments. Whilst in this setting the arguments in favour of the Rule of Rescue have generally (...)
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  17. Piotr S. Iwanowski (2007). Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective. Science and Engineering Ethics 13 (3):333-336.score: 21.0
    Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, (...)
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  18. John C. Fletcher (1985). Ethical Issues in and Beyond Prospective Clinical Trials of Human Gene Therapy. Journal of Medicine and Philosophy 10 (3):293-310.score: 21.0
    As the potential for the first human trials of somatic cell gene therapy nears, two ethical issues are examined: (1) problems of moral choice for members of institutional review boards who consider the first protocols, for parents, and for the clinical researchers, and the special protections that may be required for the infants and children to be involved, and (2) ethical objections to somatic cell therapy made by those concerned about a putative inevitable progression of genetic knowledge from (...)
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  19. Corrado Viafora (1999). Toward a Methodology for the Ethical Analysis of Clinical Practice. Medicine, Health Care and Philosophy 2 (3):283-297.score: 21.0
    The scope of this essay is to introduce and explain the methodology underlying the Lanza Foundation Protocol for the analysis of clinical cases. The essay is divided in three parts. Part one examines the Protocol's methodology within the whole evolutionary framework of argumentation in bioethics. Particular attention is given to the most significant methodologies developed in European bioethics. Part two describes the system of argumentation which serves as a frame for both approaches, namely, the normative and the hermeneutical. Finally, (...)
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  20. T. Lysaght, B. J. Capps, A. V. Campbell, M. Subramaniam & S. -A. Chong (2012). Intervening in Clinical Research to Prevent the Onset of Psychoses: Conflicts and Obligations. Journal of Medical Ethics 38 (5):319-321.score: 21.0
    A prevailing issue in clinical research is the duty clinicians have to treat or prevent the progression of disease during a study that they are conducting. While all clinical researchers have a duty of care for the patients who participate in clinical research, intervening at the onset or progression of disease may skew results and have a negative impact on the scientific validity of a study. Extreme examples of failures to intervene can be found in the Tuskegee (...)
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  21. Laura Weiss Roberts, Teddy D. Warner, Laura B. Dunn, Janet L. Brody, Katherine Green Hammond & Brian B. Roberts (2007). Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized, Controlled Educational Intervention. Ethics and Behavior 17 (1):19 – 50.score: 21.0
    The effects of research ethics training on medical students' attitudes about clinical research are examined. A preliminary randomized controlled trial evaluated 2 didactic approaches to ethics training compared to a no-intervention control. The participant-oriented intervention emphasized subjective experiences of research participants (empathy focused). The criteria-oriented intervention emphasized specific ethical criteria for analyzing protocols (analytic focused). Compared to controls, those in the participant-oriented intervention group exhibited greater attunement to research participants' attitudes related to altruism, trust, quality of relationships with (...)
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  22. M. I. Zia, R. Heslegrave & G. E. Newton (2011). Post-Trial Period Surveillance for Randomised Controlled Cardiovascular Studies: Submitted Protocols, Consent Forms and the Role of the Ethics Board. Journal of Medical Ethics 37 (12):762-765.score: 21.0
    Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised trials of chronic therapies for cardiac (...)
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  23. G. Benhamou-Jantelet (2001). Nurses' Ethical Perceptions of Health Care and of Medical Clinical Research: An Audit in a French University Teaching Hospital. Nursing Ethics 8 (2):114-122.score: 21.0
    Very few data exist in France on: (1) nurses’ knowledge and behaviour concerning ethical decisions in clinical practice; and (2) their knowledge of ethical rules in clinical research. This questionnaire-based audit tried mainly to assess these questions in a large French university teaching hospital. Of the 257 questionnaires distributed to nurses in 23 clinical units of the hospital, 206 were returned (80% response rate). When responding to the vignette describing a clinical situation requiring an ethical decision (...)
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  24. J. M. Barton, M. S. Macmillan & L. Sawyer (1995). The Compensation of Patients Injured in Clinical Trials. Journal of Medical Ethics 21 (3):166-169.score: 21.0
    The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the (...)
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  25. H. M. Evans (2004). Should Patients Be Allowed to Veto Their Participation in Clinical Research? Journal of Medical Ethics 30 (2):198-203.score: 21.0
    Patients participating in the shared benefits of publicly funded health care enjoy the benefits of treatments tested on previous patients. Future patients similarly depend on treatments tested on present patients. Since properly designed research assumes that the treatments being studied are—so far as is known at the outset—equivalent in therapeutic value, no one is clinically disadvantaged merely by taking part in research, provided the research involves administering active treatments to all participants. This paper argues that, because no other practical or (...)
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  26. D. J. Opel, B. S. Wilfond, D. Brownstein, D. S. Diekema & R. A. Pearlman (2009). Characterisation of Organisational Issues in Paediatric Clinical Ethics Consultation: A Qualitative Study. Journal of Medical Ethics 35 (8):477-482.score: 21.0
    Background: The traditional approach to resolving ethics concerns may not address underlying organisational issues involved in the evolution of these concerns. This represents a missed opportunity to improve quality of care “upstream”. The purpose of this study was to understand better which organisational issues may contribute to ethics concerns. Methods: Directed content analysis was used to review ethics consultation notes from an academic children’s hospital from 1996 to 2006 (N = 71). The analysis utilised 18 categories of organisational issues derived (...)
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  27. Elizabeth Bogdan-Lovis, Leonard Fleck & Henry C. Barry (2012). It's Not Fair! Or is It? The Promise and the Tyranny of Evidence-Based Performance Assessment. Theoretical Medicine and Bioethics 33 (4):293-311.score: 21.0
    Evidence-based medicine (EBM), by its ability to decrease irrational variations in health care, was expected to improve healthcare quality and outcomes. The utility of EBM principles evolved from individual clinical decision-making to wider foundational clinical practice guideline applications, cost containment measures, and clinical quality performance measures. At this evolutionary juncture one can ask the following questions. Given the time-limited exigencies of daily clinical practice, is it tenable for clinicians to follow guidelines? Whose or what interests are (...)
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  28. B. Pignatelli (2005). Authorship Ignorance: Views of Researchers in French Clinical Settings. Journal of Medical Ethics 31 (10):578-581.score: 21.0
    Objectives: To assess the knowledge and behaviour of researchers regarding criteria for authorship, and the practices of ghost and gift authorship. Design: Semidirective interviews of senior clinical researchers. Setting: University hospital. Participants: Thirty-nine main investigators of clinical research programmes. Main measurements: Awareness and use of International Committee of Medical Journal Editors (ICMJE) criteria for authorship, and perceptions about ghost and gift authorship. Results: A total of 48 protocols submitted by 42 principal investigators between 1994 and 1996 were (...)
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  29. Evelyne Decullier, Véronique Lhéritier & François Chapuis (2005). The Activity of French Research Ethics Committees and Characteristics of Biomedical Research Protocols Involving Humans: A Retrospective Cohort Study. [REVIEW] BMC Medical Ethics 6 (1):1-10.score: 21.0
    Background Clinical trials throughout the world must be evaluated by research ethics committees. No one has yet attempted to clearly quantify at the national level the activity of ethics committees and describe the characteristics of the protocols submitted. The objectives of this study were to describe 1) the workload and the activity of Research Ethics Committees in France, and 2) the characteristics of protocols approved on a nation-wide basis. Methods Retrospective cohort of 976 protocols approved by (...)
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  30. Daniel Groll (2011). What Health Care Providers Know: A Taxonomy of Clinical Disagreements. Hastings Center Report 41 (5):27-36.score: 18.0
    When, if ever, can healthcare provider's lay claim to knowing what is best for their patients? In this paper, I offer a taxonomy of clinical disagreements. The taxonomy, I argue, reveals that healthcare providers often can lay claim to knowing what is best for their patients, but that oftentimes, they cannot do so *as* healthcare providers.
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  31. Hillel D. Braude (2009). Clinical Intuition Versus Statistics: Different Modes of Tacit Knowledge in Clinical Epidemiology and Evidence-Based Medicine. Theoretical Medicine and Bioethics 30 (3):181-198.score: 18.0
    Despite its phenomenal success since its inception in the early nineteen-nineties, the evidence-based medicine movement has not succeeded in shaking off an epistemological critique derived from the experiential or tacit dimensions of clinical reasoning about particular individuals. This critique claims that the evidence-based medicine model does not take account of tacit knowing as developed by the philosopher Michael Polanyi. However, the epistemology of evidence-based medicine is premised on the elimination of the tacit dimension from clinical judgment. This is (...)
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  32. Edmund D. Pellegrino (2005). Some Things Ought Never Be Done: Moral Absolutes in Clinical Ethics. [REVIEW] Theoretical Medicine and Bioethics 26 (6):469-486.score: 18.0
    Moral absolutes have little or no moral standing in our morally diverse modern society. Moral relativism is far more palatable for most ethicists and to the public at large. Yet, when pressed, every moral relativist will finally admit that there are some things which ought never be done. It is the rarest of moral relativists that will take rape, murder, theft, child sacrifice as morally neutral choices. In general ethics, the list of those things that must never be done will (...)
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  33. Joel Lexchin (2012). Those Who Have the Gold Make the Evidence: How the Pharmaceutical Industry Biases the Outcomes of Clinical Trials of Medications. [REVIEW] Science and Engineering Ethics 18 (2):247-261.score: 18.0
    Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. The aim of this article is to investigate the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology (...)
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  34. Peter C. Gøtzsche (2007). Rational Diagnosis and Treatment: Evidence-Based Clinical Decision-Making. J. Wiley.score: 18.0
    Now in its fourth edition, Rational Diagnosis and Treatment: Evidence-Based Clinical Decision-Making is a unique book to look at evidence-based medicine and the difficulty of applying evidence from group studies to individual patients._ The book analyses the successive stages of the decision process and deals with topics such as the examination of the patient,_the reliability of clinical data, the logic of diagnosis, the fallacies of uncontrolled therapeutic experience and the need for randomised clinical trials and meta-analyses. It (...)
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  35. Sarah J. L. Edwards & James Wilson (2012). Hard Paternalism, Fairness and Clinical Research: Why Not? Bioethics 26 (2):68-75.score: 18.0
    Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be practicable for (...)
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  36. Kathryn Montgomery (2006). How Doctors Think: Clinical Judgment and the Practice of Medicine. Oxford University Press.score: 18.0
    How Doctors Think defines the nature and importance of clinical judgment. Although physicians make use of science, this book argues that medicine is not itself a science but rather an interpretive practice that relies on clinical reasoning. A physician looks at the patient's history along with the presenting physical signs and symptoms and juxtaposes these with clinical experience and empirical studies to construct a tentative account of the illness. How Doctors Think is divided into four parts. Part (...)
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  37. Matteo Turilli (2007). Ethical Protocols Design. Ethics and Information Technology 9 (1):49-62.score: 18.0
    The paper offers a solution to the problem of specifying computational systems that behave in accordance with a given set of ethical principles. The proposed solution is based on the concepts of ethical requirements and ethical protocols. A new conceptual tool, called the Control Closure of an operation, is defined and used to translate ethical principles into ethical requirements and protocols. The concept of Generalised Informational Privacy (GIP) is used as a paradigmatic example of an ethical principle. GIP (...)
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  38. Marcin Waligora (2013). Failures in Clinical Trials in the European Union: Lessons From the Polish Experience. Science and Engineering Ethics 19 (3):1087-1098.score: 18.0
    When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical (...)
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  39. Richard M. Zaner (2006). The Phenomenon of Vulnerability in Clinical Encounters. Human Studies 29 (3):283 - 294.score: 18.0
    After a brief, personal reflection on Aron Gurwitsch’s life and his many influences on my career, I devote this lecture to some of the central themes of a phenomenology of medicine. Its core is the clinical encounter, which displays a certain structure I term the asymmetry of power (physician) and vulnerability (patient, family)—a complex contextual imbalance characterized by multiple points of view, hence points for reflective entrance. These are then interpreted phenomenologically in terms of epoché and reduction (practical distantiation), (...)
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  40. Atsushi Asai & Yasuhiro Kadooka (2013). Reexamination of the Ethics of Placebo Use in Clinical Practice. Bioethics 27 (4):186-193.score: 18.0
    A placebo is a substance or intervention believed to be inactive, but is administered by the healthcare professional as if it was an active medication. Unlike standard treatments, clinical use of placebo usually involves deception and is therefore ethically problematic. Our attitudes toward the clinical use of placebo, which inevitably includes deception or withholding information, have a tremendous effect on our practice regarding truth-telling and informed consent. A casual attitude towards it weakens the current practice based on shared (...)
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  41. Toby Schonfeld (2013). The Perils of Protection: Vulnerability and Women in Clinical Research. Theoretical Medicine and Bioethics 34 (3):189-206.score: 18.0
    Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...)
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  42. Márcio Fabri dos Anjos (2013). Conflitos de convicções em bioética clínica (Conflict of convictions on Clinical Bioethics) - DOI: 10.5752/P.2175-5841.2013v11n30p607. [REVIEW] Horizonte 11 (30):607-626.score: 18.0
    O conflito de convicções traz consigo frequentes interrogações éticas em diferentes esferas das relações sociais. As convicções religiosas não são as únicas nesse sentido. Este ensaio usa um método interdisciplinar em vista de esclarecer alguns conceitos e critérios subjacentes ao tema, que podem ajudar no discernimento ético de tais conflitos. A Bioética Clínica é aqui uma particularização temática que ajuda uma concentração do discurso, ao mesmo tempo em que permite o aproveitamento desta reflexão para outras esferas. Ajuda também a perceber (...)
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  43. Sally Bean (2011). Navigating the Murky Intersection Between Clinical and Organizational Ethics: A Hybrid Case Taxonomy. Bioethics 25 (6):320-325.score: 18.0
    Ethical challenges that arise within healthcare delivery institutions are currently categorized as either clinical or organizational, based on the type of issue. Despite this common binary issue-based methodology, empirical study and increasing academic dialogue indicate that a clear line cannot easily be drawn between organizational and clinical ethics. Disagreement around end-of-life treatments, for example, often spawn value differences amongst parties at both organizational and clinical levels and requires a resolution to address both the case at hand and (...)
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  44. Linda Farber Post (2007). Handbook for Health Care Ethics Committees. Johns Hopkins University Press.score: 18.0
    The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the complex ethical (...)
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  45. Roger Stanev (2012). Review of The Oxford Textbook of Clinical Research Ethics, by D. Wendler, C. Grady, R. Crouch, R. Lie, F. Miller, and E. Emanuel. Theoretical Medicine and Bioethics 33 (3):221-226.score: 18.0
    When is clinical research ethical? The difficulty in answering this question lies in the dual nature of research on human subjects, which yields two somewhat conflicting sets of obligations. On the one hand, there is the traditional view of science that includes the idea of an obligation to learn about the world. On the other hand, there is the obligation of care on the part of researchers towards individual participants in the research ...
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  46. Dorota Śwituła (2006). The Concept of Quality in Clinical Research. Science and Engineering Ethics 12 (1):147-156.score: 18.0
    Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000.
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  47. George J. Agich (2009). The Issue of Expertise in Clinical Ethics. Diametros 22:3-20.score: 18.0
    The proliferation of ethics committees and ethics consultation services has engendered a discussion of the issue of the expertise of those who provide clinical ethics consultation services. In this paper, I discuss two aspects of this issue: the cognitive dimension or content knowledge that the clinical ethics consultant should possess and the practical dimension or set of dispositions, skills, and traits that are necessary for effective ethics consultation. I argue that the failure to differentiate and fully explicate these (...)
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  48. Diego Garcia (2001). Moral Deliberation: The Role of Methodologies in Clinical Ethics. [REVIEW] Medicine, Health Care and Philosophy 4 (2):223-232.score: 18.0
    The experience of the last thirty years has shown that whether the different methodologies used in clinical ethics work well or not depends on certain external factors, such as the mentality with which they are used. This article aims to analyze two of these mentalities: the “dilemmatic” and the “problematic.” The former uses preferably the decision-making theory, whilst the latter emphasizes above all the role of deliberation. The author considers that Clinical Ethics must be deliberationist, and that only (...)
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  49. Dorota Switula (2000). Principles of Good Clinical Practice (GCP) in Clinical Research. Science and Engineering Ethics 6 (1):71-77.score: 18.0
    Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.
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  50. Marek Czarkowski (2006). The Protection of Patients' Rights in Clinical Trials. Science and Engineering Ethics 12 (1):131-138.score: 18.0
    The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the (...)
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