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  1. Non-Beneficial Pediatric Research: Individual and Social Interests.Jan Piasecki, Marcin Waligora & Vilius Dranseika - 2015 - Medicine, Health Care and Philosophy 18 (1):103-112.
    Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...)
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  • Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):14.
    Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four (...)
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  • The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.Charles J. Kowalski, Raymond J. Hutchinson & Adam J. Mrdjenovich - 2017 - Journal of Medicine and Philosophy 42 (1):7-32.
    The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...)
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  • An Ethics Framework for Big Data in Health and Research.Vicki Xafis, G. Owen Schaefer, Markus K. Labude, Iain Brassington, Angela Ballantyne, Hannah Yeefen Lim, Wendy Lipworth, Tamra Lysaght, Cameron Stewart, Shirley Sun, Graeme T. Laurie & E. Shyong Tai - 2019 - Asian Bioethics Review 11 (3):227-254.
    Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and (...)
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  • Revealing the Results of Whole-Genome Sequencing and Whole-Exome Sequencing in Research and Clinical Investigations: Some Ethical Issues: Table 1.Nina Hallowell, Alison Hall, Corinna Alberg & Ron Zimmern - 2015 - Journal of Medical Ethics 41 (4):317-321.
  • Towards a National Genomics Medicine Service: The Challenges Facing Clinical-Research Hybrid Practices and the Case of the 100 000 Genomes Project. [REVIEW]Sandi Dheensa, Gabrielle Samuel, Anneke M. Lucassen & Bobbie Farsides - 2018 - Journal of Medical Ethics 44 (6):397-403.
    Clinical practice and research are governed by distinct rules and regulations and have different approaches to, for example, consent and providing results. However, genomics is an example of where research and clinical practice have become codependent. The 100 000 genomes project is a hybrid venture where a person can obtain a clinical investigation only if he or she agrees to also participate in ongoing research—including research by industry and commercial companies. In this paper, which draws on 20 interviews with professional (...)
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  • AI-Assisted Decision-Making in Healthcare: The Application of an Ethics Framework for Big Data in Health and Research.Tamra Lysaght, Hannah Yeefen Lim, Vicki Xafis & Kee Yuan Ngiam - 2019 - Asian Bioethics Review 11 (3):299-314.
    Artificial intelligence is set to transform healthcare. Key ethical issues to emerge with this transformation encompass the accountability and transparency of the decisions made by AI-based systems, the potential for group harms arising from algorithmic bias and the professional roles and integrity of clinicians. These concerns must be balanced against the imperatives of generating public benefit with more efficient healthcare systems from the vastly higher and accurate computational power of AI. In weighing up these issues, this paper applies the deliberative (...)
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  • Research and Global Health Emergencies: On the Essential Role of Best Practice.Nayha Sethi - 2018 - Public Health Ethics 11 (3):237-250.
    This article addresses an important, overlooked regulatory challenge during global health emergencies. It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing (...)
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  • New Directions in Philosophy of Medicine.Jacob Stegenga, Ashley Kennedy, Serife Tekin, Saana Jukola & Robyn Bluhm - forthcoming - In James Marcum (ed.), Bloomsbury Companion to Contemporary Philosophy of Medicine. Bloomsbury Academic. pp. 343-367.
    The purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...)
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  • An Epistemic Argument for Research-Practice Integration in Medicine.Robyn Bluhm & Kirstin Borgerson - 2018 - Journal of Medicine and Philosophy 43 (4):469-484.
    Arguments in favor of greater research-practice integration in medicine have tended to be ethical, political, or pragmatic. There are good epistemic reasons to pursue greater integration, and it is important to think through these reasons in order to avoid inadvertently designing new systems in ways that replicate the epistemic elitism common within current systems. Meaningful transformation within health care is possible with close attention to all reasons in favor of greater research-practice integration, including epistemic reasons.
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  • Ethical Issues in Pragmatic Randomized Controlled Trials: A Review of the Recent Literature Identifies Gaps in Ethical Argumentation. [REVIEW]Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Dean A. Fergusson, Jeremy M. Grimshaw, Austin R. Horn & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):1-10.
    Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Results Our (...)
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  • Innovation in a Learning Healthcare System.Henry S. Sacks & Rosamond Rhodes - 2019 - American Journal of Bioethics 19 (6):19-21.
    Volume 19, Issue 6, June 2019, Page 19-21.
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  • Consent for Research Participation in Practice.Robert M. Califf - 2019 - American Journal of Bioethics 19 (4):19-21.
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  • Ethical Oversight in Quality Improvement and Quality Improvement Research: New Approaches to Promote a Learning Health Care System.Kevin Fiscella, Jonathan N. Tobin, Jennifer K. Carroll, Hua He & Gbenga Ogedegbe - 2015 - BMC Medical Ethics 16 (1):63.
    Institutional review boards distinguish health care quality improvement and health care quality improvement research based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR.
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  • Kenyan Health Stakeholder Views on Individual Consent, General Notification and Governance Processes for the Re-Use of Hospital Inpatient Data to Support Learning on Healthcare Systems.Daniel Mbuthia, Sassy Molyneux, Maureen Njue, Salim Mwalukore & Vicki Marsh - 2019 - BMC Medical Ethics 20 (1):3.
    Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of (...)
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  • Ethics and Collateral Findings in Pragmatic Clinical Trials.Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra J. H. Mathews & Jeremy Sugarman - 2020 - American Journal of Bioethics 20 (1):6-18.
    Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...)
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  • Ethical Justifications for Access to Unapproved Medical Interventions: An Argument for (Limited) Patient Obligations.Mary Jean Walker, Wendy A. Rogers & Vikki Entwistle - 2014 - American Journal of Bioethics 14 (11):3-15.
    Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for?and demands on?these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including (...)
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  • Informed Consent for Comparative Effectiveness Research Should Include Risks of Standard Care.Lois Shepherd - 2017 - Journal of Law, Medicine and Ethics 45 (3):352-364.
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  • Learning Health System — Moving From Ethical Frameworks to Practical Implementation.Stephanie R. Morain, Mary A. Majumder & Amy L. McGuire - 2019 - Journal of Law, Medicine and Ethics 47 (3):454-458.
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  • Rethinking the Regulatory Triggers for Prospective Ethics Review.Carl H. Coleman - 2019 - Journal of Law, Medicine and Ethics 47 (2):247-253.
    Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...)
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  • Patient and Physician Views About Protocolized Dialysis Treatment in Randomized Trials and Clinical Care.Ashley Kraybill, Laura M. Dember, Steven Joffe, Jason Karlawish, Susan S. Ellenberg, Vanessa Madden & Scott D. Halpern - 2016 - Ajob Empirical Bioethics 7 (2):106-115.
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  • Clinical Trials Infrastructure as a Quality Improvement Intervention in Low- and Middle-Income Countries.Avram Denburg, Carlos Rodriguez-Galindo & Steven Joffe - 2016 - American Journal of Bioethics 16 (6):3-11.
    Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes of (...)
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  • Ethical Review of Health Systems Research in Low- and Middle-Income Countries: Research–Treatment Distinction and Intercultural Issues.Shivam Gupta - 2014 - American Journal of Bioethics 14 (2):44-46.
  • Conceptualizing Ancillary Care Obligations in Health Systems Research.Nate W. Olson - 2014 - American Journal of Bioethics 14 (2):46-47.
  • Quality Improvement Ethics: Lessons From the SUPPORT Study.Benjamin S. Wilfond - 2013 - American Journal of Bioethics 13 (12):14-19.
    The Office of Human Research Protections was not justified in issuing findings against the SUPPORT Institutions. Our community can learn from the evolving healthcare transformation into learning health systems by thinking about the novel ethical issues about standard of care research raised by the SUPPORT with the same spirit of quality improvement. The current regulatory framework and the concept of foreseeable research risks is insufficient to advance the debate about the ethics of randomization of standard clinical interventions. This article uses (...)
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  • Learning to Regulate Learning Healthcare Systems.Jan Piasecki & Vilius Dranseika - 2019 - Cambridge Quarterly of Healthcare Ethics 28 (2):369-377.
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  • Alternative Consent Models for Comparative Effectiveness Studies: Views of Patients From Two Institutions.Nancy Kass, Ruth Faden, Rachel E. Fabi, Stephanie Morain, Kristina Hallez, Danielle Whicher, Sean Tunis, Rachael Moloney, Donna Messner & James Pitcavage - 2016 - Ajob Empirical Bioethics 7 (2):92-105.
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  • What Makes Public Health Studies Ethical? Dissolving the Boundary Between Research and Practice.Donald J. Willison, Nancy Ondrusek, Angus Dawson, Claudia Emerson, Lorraine E. Ferris, Raphael Saginur, Heather Sampson & Ross Upshur - 2014 - BMC Medical Ethics 15 (1):61.
    The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...)
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  • Should Epidemiological Studies Be Subject to Ethics Review?Jan Piasecki, Vilius Dranseika & Marcin Waligora - 2018 - Public Health Ethics 11 (2):213-220.
    Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...)
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  • Adolescent Research Participants' Descriptions of Medical Research.Christine Grady, Isabella Nogues, Lori Wiener, Benjamin S. Wilfond & David Wendler - 2016 - Ajob Empirical Bioethics 7 (1):1-7.
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  • When Clinical Care is Like Research: The Need for Review and Consent.David Wendler & Rebecca Johnson - 2016 - Theoretical Medicine and Bioethics 37 (3):193-209.
    The prevailing “segregated model” for understanding clinical research sharply separates it from clinical care and subjects it to extensive regulations and guidelines. This approach is based on the fact that clinical research relies on procedures and methods—research biopsies, blinding, randomization, fixed treatment protocols, placebos—that pose risks and burdens to participants in order to collect data that might benefit all patients. Reliance on these methods raises the potential for exploitation and unfairness, and thus points to the need for independent ethical review (...)
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  • How Do Young People with Cystic Fibrosis Conceptualize the Distinction Between Research and Treatment? A Qualitative Interview Study.Jennifer A. Dobson, Emily Christofides, Melinda Solomon, Valerie Waters & Kieran O’Doherty - 2015 - Ajob Empirical Bioethics 6 (4):1-11.
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  • Physicians’ Communication Patterns for Motivating Rectal Cancer Patients to Biomarker Research: Empirical Insights and Ethical Issues.Sabine Wöhlke, Julia Perry & Silke Schicktanz - 2018 - Clinical Ethics 13 (4):175-188.
    In clinical research – whether pharmaceutical, genetic or biomarker research – it is important to protect research participants’ autonomy and to ensure or strengthen their control over health-related decisions. Empirical–ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. For this, a better understanding of recruitment, for which also the physician–patient relationship plays an important role, is needed.Our aim is to ethically reflect communication (...)
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  • The Research‐Clinical Practice Distinction, Learning Health Systems, and Relationships.Howard Brody & Franklin G. Miller - 2013 - Hastings Center Report 43 (5):41-47.
  • What's Trust Got to Do With It? Trust and the Importance of the Research–Care Distinction.Emily A. Largent - 2015 - American Journal of Bioethics 15 (9):22-24.
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  • Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making.Maureen Kelley, Cyan James, Stephanie Alessi Kraft, Diane Korngiebel, Isabelle Wijangco, Emily Rosenthal, Steven Joffe, Mildred K. Cho, Benjamin Wilfond & Sandra Soo-Jin Lee - 2015 - American Journal of Bioethics 15 (9):4-17.
    We conducted focus groups to assess patient attitudes toward research on medical practices in the context of usual care. We found that patients focus on the implications of this research for their relationship with and trust in their physicians. Patients view research on medical practices as separate from usual care, demanding dissemination of information and in most cases, individual consent. Patients expect information about this research to come through their physician, whom they rely on to identify and filter associated risks. (...)
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  • Research Translation and Emerging Health Technologies: Synthetic Biology and Beyond.Sarah Chan - 2018 - Health Care Analysis 26 (4):310-325.
    New health technologies are rapidly emerging from various areas of bioscience research, such as gene editing, regenerative medicine and synthetic biology. These technologies raise promising medical possibilities but also a range of ethical considerations. Apart from the issues involved in considering whether novel health technologies can or should become part of mainstream medical treatment once established, the process of research translation to develop such therapies itself entails particular ethical concerns. In this paper I use synthetic biology as an example of (...)
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  • The Ethics of Using Complementary Medicine in Pediatric Oncology Trials: Reconciling Challenges.Amy S. Porter & Eric Kodish - 2018 - Journal of Law, Medicine and Ethics 46 (1):64-71.
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