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: 144.0
    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. 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: 120.0
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  3. Daniel W. Fitzgerald, Angela Wasunna & Jean William Pape (forthcoming). Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols. Irb.score: 120.0
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  4. Frederick Grinnell (forthcoming). Endings of Clinical Research Protocols: Distinguishing Therapy From Research. Irb.score: 120.0
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  5. Brian Hurwitz (1995). Clinical Guidelines and the Law: Advice, Guidance or Regulation? Journal of Evaluation in Clinical Practice 1 (1):49-60.score: 96.0
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  6. 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: 90.0
    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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  7. E. A. Waters (1997). Improving Clinical Effectiveness: A Practical Approach. Journal of Evaluation in Clinical Practice 3 (4):255-264.score: 84.0
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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: 78.0
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  9. Jill A. Fisher (2008). Institutional Mistrust in the Organization of Pharmaceutical Clinical Trials. Medicine, Health Care and Philosophy 11 (4):403-413.score: 66.0
    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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  10. 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: 60.0
    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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  11. 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: 60.0
    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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  12. A. Stroustrup, S. Kornetsky & S. Joffe (2007). Knowledge of Regulations Governing Pediatric Research: A Pilot Study. Irb 30 (5):1-7.score: 60.0
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  13. H. C. M. L. Rodrigues & P. P. van den Berg (2014). Randomized Controlled Trials of Maternal‐Fetal Surgery: A Challenge to Clinical Equipoise. Bioethics 28 (8):405-413.score: 54.0
    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be (...)
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  14. 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: 54.0
    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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  15. 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: 54.0
    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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  16. 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: 54.0
    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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  17. 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: 54.0
    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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  18. 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: 54.0
    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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  19. 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: 54.0
    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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  20. H. M. Evans (2004). Should Patients Be Allowed to Veto Their Participation in Clinical Research? Journal of Medical Ethics 30 (2):198-203.score: 54.0
    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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  21. 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: 54.0
    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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  22. B. Pignatelli (2005). Authorship Ignorance: Views of Researchers in French Clinical Settings. Journal of Medical Ethics 31 (10):578-581.score: 54.0
    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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  23. 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: 54.0
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  24. 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: 54.0
    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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  25. Paul J. Ford (2007). Neurosurgical Implants: Clinical Protocol Considerations. Cambridge Quarterly of Healthcare Ethics 16 (03):308-311.score: 50.0
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  26. W. French Anderson (forthcoming). O Nlanuary 19, 1989, the Director of the National Institutes of Health (NIH), Dr. Iames A. Wyn-Gaarden, Approved Our Clinical Protocol to Insert a Foreign Gene Into The. [REVIEW] Bioethics: Basic Writings on the Key Ethical Questions That Surround the Major, Modern Biological Possibilities and Problems.score: 50.0
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  27. 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: 48.0
    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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  28. A. Miles, P. Bentley, J. Grey & A. Polychronis (1995). Purchasing Quality in Clinical Practice: What on Earth Do We Mean? Journal of Evaluation in Clinical Practice 1 (2):87-95.score: 48.0
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  29. 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: 42.0
    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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  30. 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: 42.0
    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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  31. C. Roy-Toole (2008). Illegality in the Research Protocol: The Duty of Research Ethics Committees Under the 2001 Clinical Trials Directive. Research Ethics 4 (3):111-116.score: 40.0
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  32. Doris Wilborn, Ruud Halfens & Theo Dassen (2006). Pressure Ulcer: Prevention Protocols and Prevalence. Journal of Evaluation in Clinical Practice 12 (6):630-638.score: 40.0
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  33. Lorena Charrier, Maria Cristina Allochis, Maria Rita Cavallo, Dario Gregori, Franco Cavallo & Carla Maria Zotti (2008). Integrated Audit as a Means to Implement Unit Protocols: A Randomized and Controlled Study. Journal of Evaluation in Clinical Practice 14 (5):847-853.score: 40.0
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  34. Rafael Ortega & Rafael Dal-Ré (forthcoming). Clinical Trials Committees: How Long Is the Protocol Review and Approval Process in Spain? A Prospective Study. Irb.score: 40.0
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  35. Audrey Smith Rogers, Donald F. Schwartz, Gloria Weissman & A. English (1998). A Case Study in Adolescent Participation in Clinical Research: Eleven Clinical Sites, One Common Protocol, and Eleven IRBs. Irb 21 (1):6-10.score: 40.0
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  36. 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: 38.0
    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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  37. Corrado Viafora (1999). Toward a Methodology for the Ethical Analysis of Clinical Practice. Medicine, Health Care and Philosophy 2 (3):283-297.score: 38.0
    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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  38. Linda Farber Post (2007). Handbook for Health Care Ethics Committees. Johns Hopkins University Press.score: 36.0
    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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  39. Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills (2009). Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials. Developing World Bioethics 9 (2):74-80.score: 36.0
    Objective: Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. Methods: We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We (...)
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  40. Lara Huber (2008). Imaging the Brain: Visualising “Pathological Entities”? Searching for Reliable Protocols Within Psychiatry and Their Impact on the Understanding of Psychiatric Diseases. [REVIEW] Poiesis and Praxis 6 (1-2):27-41.score: 36.0
    Given that visualisations via medical imaging have tremendously increased over the last decades, the overall presence of colour-coded brain slices generated on the basis of functional imaging, i.e. neuroimaging techniques, have led to the assumption of so-called kinds of brains or cognitive profiles that might be especially related to non-healthy humans affected by neurological, neuropsychological or psychiatric syndromes or disorders. In clinical contexts especially, one must consider that visualisations through medical imaging are suggestive in a twofold way. Imaging data (...)
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  41. Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska, Monitoring Clinical Research: An Obligation Unfulfilled.score: 36.0
    The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of the integrity of data. (...)
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  42. Faiz Khan (2008). An Islamic Appraisal of Minding the Gap. Journal of Religious Ethics 36 (1):77-96.score: 36.0
    The neglect of psycho-spiritual needs of patients as they traverse the modern healthcare system has been a featured theme in medical literature over the past decade. This literature, which often highlights in-patient palliative care, as well as acute and critical care settings, influences practice guidelines and protocols of doctors and nurses. In this essay, I review some of the pertinent issues raised in the literature and examine the validity of placing an ethical perspective on this issue. I also compare (...)
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  43. A. Nyika, W. Kilama, R. Chilengi, G. Tangwa, P. Tindana, P. Ndebele & J. Ikingura (2009). Composition, Training Needs and Independence of Ethics Review Committees Across Africa: Are the Gate-Keepers Rising to the Emerging Challenges? Journal of Medical Ethics 35 (3):189-193.score: 36.0
    Background: The high disease burden of Africa, the emergence of new diseases and efforts to address the 10/90 gap have led to an unprecedented increase in health research activities in Africa. Consequently, there is an increase in the volume and complexity of protocols that ethics review committees in Africa have to review. Methods: With a grant from the Bill and Melinda Gates Foundation, the African Malaria Network Trust (AMANET) undertook a survey of 31 ethics review committees (ERCs) across sub-Saharan (...)
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  44. Helen M. Sharp & Robert D. Orr (2004). When "Minimal Risk" Research Yields Clinically-Significant Data, Maybe the Risks Aren't So Minimal. American Journal of Bioethics 4 (2):32-36.score: 34.0
    Surveys and routine clinical procedures applied in research protocols are typically considered only minimally risky to participants. The apparent benign nature of "minimal risk" tasks increases the chance that investigators and Institutional Review Boards (IRBs) will overlook the probability that clinical tools will identify signs, symptoms, or definitive test results that are clinically-relevant to subjects' welfare. "Minimal risk" procedures may also pose a particular hazard to participants in clinical research by increasing the therapeutic misconception because the (...)
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  45. David B. Resnik (2009). The Clinical Investigator-Subject Relationship: A Contextual Approach. Philosophy, Ethics, and Humanities in Medicine 4 (1):16-.score: 30.0
    BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's (...)
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  46. Charles Weijer, Benjamin Freedman, Stanley Shapiro, Abraham Fuks, Myriam Skrutkowska & Maria Sigurjonsdottir, Assessing the Interpretation of Criteria for Clinical Trial Eligibility: A Survey of Oncology Investigators.score: 30.0
    OBJECTIVE: To investigate whether eligibility criteria that exclude the elderly, persons with psychiatric disease, and persons with substance abuse problems from participation in randomized controlled trials (RCTs) are subjective and hence a source of variability in enrolment decisions and investigator uncertainty. DESIGN: Survey questionnaire. PARTICIPANTS: Cancer investigators from the United States and Canada. INTERVENTIONS: Investigators were presented with clinical vignettes from 3 patient categories--eligible, ineligible and uncertain--for each of 5 eligibility criteria--3 subjective and 2 objective--and were asked whether they (...)
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  47. Charles Weijer, Selecting Subjects for Participation in Clinical Research: An Empirical Inquiry and Ethical Analysis.score: 30.0
    Procedures for the selection of subjects for participation in randomized clinical trials--usually formalized as eligibility criteria in the study protocol--have both scientific and ethical implications. In this thesis, I undertake an examination of eligibility criteria at three stages in the genesis and dissemination of medical knowledge: clinical trial protocol, interpretation by investigators, and reporting of study results.In the first chapter, ethical issues in subject selection are reviewed and the main study questions are presented. In the second chapter, the (...)
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  48. Stanley H. Shapiro, Charles Weijer & Benjamin Freedman, Reporting the Study Populations of Clinical Trials. Clear Transmission or Static on the Line?score: 30.0
    In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print (...)
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  49. Abraham Fuks, Charles Weijer, Benjamin Freedman, Stanley Shapiro, Myriam Skrutkowska & Amina Riaz, A Study in Contrasts: Eligibility Criteria in a Twenty-Year Sample of NSABP and POG Clinical Trials.score: 30.0
    We studied changes in eligibility criteria--the largest impediment to patient accrual--in two samples of clinical trials. Trials from the NSABP (National Surgical Adjuvant Breast and Bowel Program) and POG (Pediatric Oncology Group) were analyzed. After eliminating duplications, the criteria in each protocol were enumerated and classified according to a novel schema. NSABP trials contained significantly more criteria than POG trials, and added precision criteria (making study populations homogeneous) at a faster rate than POG studies. The difference between NSABP studies (...)
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  50. Maurizio Salvi (2003). Conflict of Interest in Biomedical Research: A View From Europe. Science and Engineering Ethics 9 (1):101-108.score: 30.0
    In this paper I address the conflict of interest (CoI) issue from a legal point of view at a European level. We will see that the regulatory framework that exists in Europe does state the need for the independence of ethics committee involved in authorisation of research and clinical trials. We will see that CoI is an element that has to be closely monitored at National and International level. Therefore, Member States and Newly Associated States do have to address (...)
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