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Nancy E. Kass, Ruth R. Faden, Steven N. Goodman, Peter Pronovost, Sean Tunis & Tom L. Beauchamp (2013). The Research‐Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.

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  1.  1
    Research and Global Health Emergencies: On the Essential Role of Best Practice.Nayha Sethi - forthcoming - Public Health Ethics:phy014.
    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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  2.  1
    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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  3.  8
    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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  4.  6
    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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  5.  2
    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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  6.  11
    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).
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  7.  3
    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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  8. 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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  9.  2
    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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  10. 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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  11.  19
    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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  12.  25
    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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  13.  23
    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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  14.  4
    Revealing the Results of Whole-Genome Sequencing and Whole-Exome Sequencing in Research and Clinical Investigations: Some Ethical Issues.N. Hallowell, A. Hall, C. Alberg & R. Zimmern - 2015 - Journal of Medical Ethics 41 (4):317-321.
  15.  13
    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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  16.  5
    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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  17.  7
    Non-Beneficial Pediatric Research: Individual and Social Interests.Jan Piasecki, Marcin Waligora & Vilius Dranseika - 2015 - Medicine, Health Care and Philosophy 18 (1):103-112.
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  18.  24
    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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  19.  2
    The Research‐Clinical Practice Distinction, Learning Health Systems, and Relationships.Howard Brody & Franklin G. Miller - 2013 - Hastings Center Report 43 (5):41-47.