Results for 'clinical research'

986 found
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  1.  49
    Conducting clinical research in polish conditions.Marek Labon - 2006 - Science and Engineering Ethics 12 (1):185-188.
    This paper comments on Polish legal guarantees for diseased persons with reference to the hazards that accompany experimental treatment. While acknowledging that participation in a clinical research program provides patients with additional opportunities for advanced treatment, the paper also points out that systems for monitoring patients participating in experimental treatment require improvement.
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  2.  25
    Clinical research should not be permitted to escape the ethical orbit of clinical care.David Steinberg - 2002 - American Journal of Bioethics 2 (2):27 – 28.
    (2002). Clinical Research Should Not Be Permitted to Escape the Ethical Orbit of Clinical Care. The American Journal of Bioethics: Vol. 2, No. 2, pp. 27-28.
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  3.  5
    Clinical research vehicles as a modality for medical research education and conduct of decentralized trials, supporting justice, equity, and diversity in research.Kenneth T. Moore - 2024 - Bioethics 39 (2):213-220.
    Current clinical research lacks diversity in those that participate. This lack of diversity is concerning given its importance for successful drug development. The frequency and severity of many diseases, along with the pharmacological properties of therapies, can display significant differences based on patient diversity. A clinical trial population that is more reflective of these differences will help researchers better understand the therapeutic profile of the treatment and provide generalizable knowledge to the medical community. The advent of decentralized (...)
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  4.  27
    Clinical research: up from 'clinical epidemiology'.Olli S. Miettinen, Lucas M. Bachmann & Johann Steurer - 2009 - Journal of Evaluation in Clinical Practice 15 (6):1208-1213.
    Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of (...)
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  5.  58
    Clinical Research in Context: Reexamining the Distinction between Research and Practice.J. A. Anderson - 2010 - Journal of Medicine and Philosophy 35 (1):46-63.
    At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry (...)
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  6.  42
    Can Clinical Research Be Both Ethical and Scientific? A Commentary inspired by Rosser and Marquis.Helen Bequaert Holmes - 1989 - Hypatia 4 (2):156-168.
    Problems with clinical research that create conflicts between doctors' therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. I suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science - to enhance the effectiveness of each.
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  7. Rethinking clinical research: methodology and ethics.Karen B. Schmaling & Robert M. Kaplan - 2025 - New York, NY: Cambridge University Press.
    This book provides a comprehensive analysis of biases inherent in contemporary clinical research, challenging traditional methodologies and assumptions. Aimed at students, professionals, and science enthusiasts, the book delves into fundamental principles, research tools, and ethics.
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  8. Clinical research law in Jordan: An ethical analysis.Ibrahim Ramahi & Henry Silverman - 2007 - Developing World Bioethics 9 (1):26-33.
    ABSTRACT An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research (...)
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  9.  78
    Clinical research with economically disadvantaged populations.C. C. Denny & C. Grady - 2007 - Journal of Medical Ethics 33 (7):382-385.
    Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or (...)
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  10.  86
    Paternalism and fairness in clinical research.Lynn A. Jansen & Steven Wall - 2008 - Bioethics 23 (3):172-182.
    In this paper, we defend the ethics of clinical research against the charge of paternalism. We do so not by denying that the ethics of clinical research is paternalistic, but rather by defending the legitimacy of paternalism in this context. Our aim is not to defend any particular set of paternalistic restrictions, but rather to make a general case for the permissibility of paternalistic restrictions in this context. Specifically, we argue that there is no basic liberty-right (...)
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  11.  68
    Avoiding Exploitation in Clinical Research.Solomon R. Benatar - 2000 - Cambridge Quarterly of Healthcare Ethics 9 (4):562-565.
    Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS (...)
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  12.  68
    Addressing the Ethical Challenges in Genetic Testing and Sequencing of Children.Ellen Wright Clayton, Laurence B. McCullough, Leslie G. Biesecker, Steven Joffe, Lainie Friedman Ross, Susan M. Wolf & For the Clinical Sequencing Exploratory Research Group - 2014 - American Journal of Bioethics 14 (3):3-9.
    American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...)
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  13.  61
    Consent to clinical research--adequately voluntary or substantially influenced?S. Hewlett - 1996 - Journal of Medical Ethics 22 (4):232-237.
    In clinical research the giving of consent by the patient often lies within the context of illness or the doctor/patient relationship. On exploration of these issues it would appear unlikely that the patient's consent is free of substantial influences, some of which may be strong enough to be controlling. Five categories of consent are suggested: voluntary, involuntary, coerced, enforced and partially voluntary. It is argued that consent in clinical research is substantially influenced and thus only partially (...)
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  14.  8
    Clinical Research Involving Pregnant Women.Françoise Baylis & Angela Ballantyne (eds.) - 2016 - Cham: Imprint: Springer.
    This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to (...)
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  15.  99
    Contextualizing clinical research: The epistemological role of clinical equipoise.James A. Anderson - 2009 - Theoretical Medicine and Bioethics 30 (4):269-288.
    Since its introduction in 1987, Benjamin Freedman’s principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a “scientific orientation” toward the ethics of (...)
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  16.  41
    Reconsidering paternalism in clinical research.Lynn A. Jansen & Steven Wall - 2017 - Bioethics 32 (1):50-58.
    The ethical standards that regulate clinical research have multiple rationales. Among them is the need to protect potential subjects from making imprudent decisions, which extends beyond the soft paternalistic concern to protect people from making uninformed decisions to participate in trials. This article argues that a plausible risk/benefit restriction on clinical trials is presumptively justified by hard paternalism, which in turn is supported by a deeper fairness-based rationale. This presumptive case for hard paternalism in research is (...)
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  17. Clinical research: Should patients pay to play?Ezekiel J. Emanuel, Steven Joffe, Christine Grady, David Wendler & Govind Persad - 2015 - Science Translational Medicine 7 (298):298ps16.
    We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.
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  18.  78
    Placebo Orthodoxy in Clinical Research I: Empirical and Methodological Myths.Benjamin Freedman, Charles Weijer & Kathleen Cranley Glass - 1996 - Journal of Law, Medicine and Ethics 24 (3):243-251.
    The use of statistics in medical research has been compared to a religion: it has its high priests, supplicants, and orthodoxy. Although the comparison may be more unfair to religion than to research, a useful lesson can nonetheless be drawn: the practice of clinical research may benefit—as does the spirit—from critical self-examination. Arguably, no aspect of the conduct of clinical trials is currently more controversial—and thus in as dire need of critical examination—than the use of (...)
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  19. Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.Jake Earl - 2019 - American Journal of Bioethics 19 (6):7-18.
    Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community (...)
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  20.  53
    Ethical challenges experienced by clinical research nurses:: A qualitative study.Mary E. Larkin, Brian Beardslee, Enrico Cagliero, Catherine A. Griffith, Kerry Milaszewski, Marielle T. Mugford, Joanna M. Myerson, Wen Ni, Donna J. Perry, Sabune Winkler & Elizabeth R. Witte - 2019 - Nursing Ethics 26 (1):172-184.
    Background: Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse–participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary (...)
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  21.  18
    The Clinical Research. A first approach.Tatiana Marañon Cardonne & León Robaina - 2015 - Humanidades Médicas 15 (1):163-184.
    La investigación clínica es la actividad encaminada a conocer el resultado de una intervención o un producto para el diagnóstico o la terapéutica en los seres humanos. El ensayo clínico es el principal exponente de la investigación clínica y toda evaluación experimental de una sustancia o medicamento en seres humanos. En Cuba, existe un desarrollo importante de la biotecnología y de los centros de investigación que necesitan de ensayos clínicos según estándares nacionales e internacionales. En el presente trabajo se exponen (...)
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  22.  73
    Placebo Orthodoxy in Clinical Research II: Ethical, Legal, and Regulatory Myths.Benjamin Freedman, Kathleen Cranley Glass & Charles Weijer - 1996 - Journal of Law, Medicine and Ethics 24 (3):252-259.
    Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration, to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical (...)
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  23.  64
    Rethinking the ethics of clinical research: widening the lens.Alan Wertheimer - 2011 - New York: Oxford University Press.
    Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.
  24.  73
    Litigation in Clinical Research: Malpractice Doctrines versus Research Realities.E. Haavi Morreim - 2004 - Journal of Law, Medicine and Ethics 32 (3):474-484.
    Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in (...) research trials that now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)
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  25.  35
    Monitoring Clinical Research: An Obligation Unfulfilled.Charles Weijer, Stanley Shapiro, Abraham Fuks, Kathleen Cranley Glass & Myriam Skrutkowska - unknown
    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 (...)
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  26.  53
    Clinical Research in Times of Pandemics.S. -A. Chong, B. J. Capps, M. Subramaniam, T. C. Voo & A. V. Campbell - 2010 - Public Health Ethics 3 (1):35-38.
    During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track (...) and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)
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  27.  24
    Modern Clinical Research: Guidelines for the Practicing Clinician or Source of Confusion?Ilia Volkov - 2013 - Journal of Clinical Ethics 24 (4):395-396.
    There is a dilemma in modern medicine, and, as a general family practitioner, this dilemma has great impact on me as a professional with a responsibility to my patients, and on the treatments I prescribe. Every day we receive a lot of updated information about relevant issues in treatment of various conditions we encounter in our daily practice. There is a great deal of interesting, serious research; however, frequently results and conclusions are very different and at times, contradictory. It (...)
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  28.  58
    Informed consent in clinical research at a general hospital in Mexico: opinions of the investigators.Laura Vargas-Parada, Simon Kawa, Alberto Salazar, Juan Jose Mazon & Ana Flisser - 2006 - Developing World Bioethics 6 (1):41-51.
    ABSTRACT In Mexico informed consent is a legal requirement that ensures that patients who are invited to participate in clinical trials are provided with all the information needed to decide whether to participate, or not, in a research protocol. To improve our understanding of the problems physicians in developing countries encounter, when obtaining informed consent (IC), we examined their opinion on the importance of IC in clinical research, the quantity and quality of the information provided to (...)
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  29.  15
    Clinical Research Consultation: A Casebook.Marion Danis (ed.) - 2012 - Oxford University Press.
    Starting research -- Enrolling research participants -- Protecting research participants -- Conducting research with vulnerable populations -- Balancing clinical research and clinical care -- Navigating interpersonal difficulties -- Ending research.
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  30.  68
    Clarifying the ethics of clinical research: A path toward avoiding the therapeutic misconception.Paul S. Appelbaum - 2002 - American Journal of Bioethics 2 (2):22 – 23.
    (2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.
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  31.  23
    Ethical Challenges in Clinical Research During the COVID-19 Pandemic.B. E. Bierer, S. A. White, J. M. Barnes & L. Gelinas - 2020 - Journal of Bioethical Inquiry 17 (4):717-722.
    The sudden emergence of the COVID-19 pandemic brought global disruption to every aspect of society including healthcare, supply chain, the economy, and social interaction. Among the many emergent considerations were the safety and public health of the public, patients, essential workers, and healthcare professionals. In certain locations, clinical research was halted—or terminated—in deference to the immediate needs of patient care, and clinical trials focusing on the treatment and prevention of coronavirus infection were prioritized over studies focusing on (...)
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  32.  20
    A pragmatic analysis of vulnerability in clinical research.David Wendler - 2017 - Bioethics 31 (7):515-525.
    Identifying which subjects are vulnerable, and implementing safeguards to protect them, is widely regarded as essential to clinical research. Commentators have endorsed a number of responses to these challenges and have thereby made significant progress in understanding vulnerability in clinical research. At the same time, this literature points to a central contradiction which calls into question its potential to protect vulnerable subjects in practice. Specifically, analysis suggests that all human subjects are vulnerable and vulnerability in (...) research is comparative and context dependent, in the sense that individuals are vulnerable relative to others and in some contexts only. Yet, if everyone is vulnerable, there seems to be no point in citing the vulnerability of some individuals. Moreover, the conclusion that everyone is vulnerable seems inconsistent with the claims that vulnerability is comparative and context dependent, raising concern over whether it will be possible to develop a comprehensive account of vulnerability that is internally consistent. The solution to this dilemma lies in recognition of the fact that the practical significance of claims regarding vulnerability depends on the context in which they are used. The claims that appear to lead to the central contradiction are in fact accurate conclusions that follow from different uses of the term ‘vulnerability’. The present manuscript describes this ‘pragmatic’ approach to vulnerability in clinical research and considers its implications for ensuring that subjects receive appropriate protection. (shrink)
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  33.  40
    Justice in international clinical research.Bridget Pratt & Bebe Loff - 2010 - Developing World Bioethics 11 (2):75-81.
    Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global (...)
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  34. Hard paternalism, fairness and clinical research: why not?Sarah J. L. Edwards & James Wilson - 2010 - Bioethics 26 (2):68 - 75.
    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 (...)
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  35.  19
    Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group.Vasiliki Rahimzadeh, Jennyfer Ambe & Jantina de Vries - 2023 - Journal of Law, Medicine and Ethics 51 (2):258-270.
    In this paper we report findings from a commissioned report to the COVID-19 Clinical Research Coalition on approaches to streamline multinational REC review/approval during public health emergencies. As currently envisioned in the literature, a system of REC mutual recognition is theoretically possible based on shared procedural REC standards, but raises numerous concerns about perceived inequities and mistrust.
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  36.  32
    Clinical research ethics in Irish healthcare: Diversity, dynamism and medicalization.Sarah L. Condell & Cecily Begley - 2012 - Nursing Ethics 19 (6):810-818.
    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as (...)
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  37.  92
    Developing Clinical Research Relationship: Views from Within.Olga Zvonareva & Lloyd Akrong - 2014 - Developing World Bioethics 15 (3):257-266.
    The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted (...)
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  38.  67
    Linking international clinical research with stateless populations to justice in global health.Bridget Pratt, Deborah Zion, Khin Maung Lwin, Phaik Yeong Cheah, Francois Nosten & Bebe Loff - 2014 - BMC Medical Ethics 15 (1):49.
    In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. (...)
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  39. Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise.Lynn A. Jansen - 2024 - Social Philosophy and Policy 41 (2):306-326.
    There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic “learning health-care system” in which research components are embedded within standard (...)
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  40.  18
    Moral distress in clinical research nurses.Brandi L. Showalter, Ann Malecha, Sandra Cesario & Paula Clutter - 2022 - Nursing Ethics 29 (7-8):1697-1708.
    Background: Clinical research nurses experience unique challenges in the context of their role that can lead to conflict and moral distress. Although examined in many areas, moral distress has not been studied in clinical research nurses. Research aim: The aim of this study was to examine moral distress in clinical research nurses and the relationship between moral distress scores and demographic characteristics of clinical research nurses. Research design: This was a (...)
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  41.  34
    The social value of clinical research.Michelle Gjl Habets, Johannes Jm van Delden & AnneLien L. Bredenoord - 2014 - BMC Medical Ethics 15 (1):66.
    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is (...)
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  42.  23
    Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.Alice Faust, Anna Sierawska, Joerg Hasford, Anne Wisgalla, Katharina Krüger & Daniel Strech - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for (...)
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  43.  65
    What we worry about when we worry about the ethics of clinical research.David Wendler - 2011 - Theoretical Medicine and Bioethics 32 (3):161-180.
    Clinical research is thought to be ethically problematic and is subject to extensive regulation and oversight. Despite frequent endorsement of this view, there has been almost no systematic evaluation of why clinical research might be ethically problematic. As a result, it is difficult to determine whether the regulations to which clinical research is subject address the ethical concerns it raises. Commentators who consider this question at all tend to assume that clinical research (...)
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  44.  19
    Financial conflicts and clinical research.Karin Meyers - 2009 - IRB: Ethics & Human Research 31 (4):17.
    “Financial Conflicts and Clinical Research’”: a letter from Karin Meyers about “Community Hospital Oversight of Clinical Investigators’ Financial Relationships ”.
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  45.  29
    The future of clinical research: from megatrials towards methodological rigour and representative sampling.Bruce G. Charlton - 1996 - Journal of Evaluation in Clinical Practice 2 (3):159-169.
  46.  17
    A Paper Machine of Clinical Research in the Early Twentieth Century.Volker Hess - 2018 - Isis 109 (3):473-493.
    This article introduces Turing’s idea of a “paper machine” to identify and understand one important mode of clinical research in the modern hospital, how that research worked, and how office technology and industrialized labor shaped and helped drive it. The unusually rich archives of Berlin psychiatry allow detailed reconstruction of the making of the new diagnostic category “hyperkinetic syndrome” in the 1920s. From the generating of data to the processing of information to the visualizing of the nature (...)
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  47.  6
    Challenging cases in clinical research ethics.Benjamin Wilfond, Liza-Marie Johnson, Devan M. Duenas & Holly Taylor (eds.) - 2023 - London: CRC Press, Taylor & Francis Group.
    Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases (...)
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    Clinical Ethics Committee in an Oncological Research Hospital: two-years Report.Marta Perin, Ludovica De Panfilis & on Behalf of the Clinical Ethics Committee of the Azienda Usl-Irccs di Reggio Emilia - 2023 - Nursing Ethics 30 (7-8):1217-1231.
    Research question and aim Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC’s implementation, to increase knowledge about CEC’s implementation strategy. Research design We collected quantitative data related to number and characteristics (...)
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  49. A plea for pragmatism in clinical research ethics.David H. Brendel & Franklin G. Miller - 2008 - American Journal of Bioethics 8 (4):24 – 31.
    Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy (...)
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    Clinical Research and its Condition in India.Geetanjali Murari - 2013 - Journal of Clinical Research and Bioethics 4 (2).
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