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  1. Privacy Challenges in Smart Homes for People with Dementia and People with Intellectual Disabilities.Fiachra O’Brolcháin & Bert Gordijn - forthcoming - Ethics and Information Technology.
  • Hypocrisy Around Medical Patient Data: Issues of Access for Biomedical Research, Data Quality, Usefulness for the Purpose and Omics Data as Game Changer.Erwin Tantoso, Wing-Cheong Wong, Wei Hong Tay, Joanne Lee, Swati Sinha, Birgit Eisenhaber & Frank Eisenhaber - 2019 - Asian Bioethics Review 11 (2):189-207.
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  • The Hippocratic Thorn in Bioethics' Hide: Cults, Sects, and Strangeness.T. Koch - 2014 - Journal of Medicine and Philosophy 39 (1):75-88.
    Bioethicists have typically disdained where they did not simply ignore the Hippocratic tradition in medicine. Its exclusivity—an oath of and for physicians—seemed contrary to the perspective that bioethicists have attempted to invoke. Robert M. Veatch recently articulated this rejection of the Hippocratic tradition, and of a professional ethic of medicine in general, in a volume based on his Gifford lectures. Here that argument is critiqued. The strengths of the Hippocratic tradition as a flexible and ethical social doctrine are offered in (...)
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  • When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?Stephanie R. Morain, Steven Joffe & Emily A. Largent - 2019 - American Journal of Bioethics 19 (4):11-18.
    Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...)
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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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  • 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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  • 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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  • 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 of patients (...)
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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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  • Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.Sandra Soo-Jin Lee, Maureen Kelley, Mildred K. Cho, Stephanie Alessi Kraft, Cyan James, Melissa Constantine, Adrienne N. Meyer, Douglas Diekema, Alexander M. Capron, Benjamin S. Wilfond & David Magnus - 2016 - Ajob Empirical Bioethics 7 (2):125-134.
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  • Rethinking the Ethical Approach to Health Information Management Through Narration: Pertinence of Ricœur’s ‘Little Ethics’.Corine Mouton Dorey - 2016 - Medicine, Health Care and Philosophy 19 (4):531-543.
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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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  • Stakeholder Views Regarding Ethical Issues in the Design and Conduct of Pragmatic Trials: Study Protocol.Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):90.
    Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...)
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  • Beyond Open Communication: A Call for Partnership Between Clinical Ethics and Research Ethics Committees.Christine Grady, David Gibbes Miller & Hae Lin Cho - 2018 - American Journal of Bioethics 18 (1):52-54.
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  • The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
    The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...)
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  • Rethinking the Belmont Report?Phoebe Friesen, Lisa Kearns, Barbara Redman & Arthur L. Caplan - 2017 - American Journal of Bioethics 17 (7):15-21.
    This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...)
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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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  • Relying on Trust for Research on Medical Practice in Learning Health Systems.Leslie Ann McNolty & Richard Payne - 2015 - American Journal of Bioethics 15 (9):30-32.
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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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  • What Should Be Disclosed to Research Participants?David Wendler - 2013 - American Journal of Bioethics 13 (12):3-8.
    Debate surrounding the SUPPORT study highlights the absence of consensus regarding what information should be disclosed to potential research participants. Some commentators endorse the view that clinical research should be subject to high disclosure standards, even when it is testing standard-of-care interventions. Others argue that trials assessing standard-of-care interventions need to disclose only the information that is disclosed in the clinical care setting. To resolve this debate, it is important to identify the ethical concerns raised by clinical research and determine (...)
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  • There's A Lot We Don't Know (and We Ought to Say So).Nancy M. P. King - 2013 - American Journal of Bioethics 13 (12):20-21.
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  • 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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  • Ensuring Respect for Persons in COMPASS: A Cluster Randomised Pragmatic Clinical Trial.Joseph E. Andrews, J. Brian Moore, Richard B. Weinberg, Mysha Sissine, Sabina Gesell, Jacquie Halladay, Wayne Rosamond, Cheryl Bushnell, Sara Jones, Paula Means, Nancy M. P. King, Diana Omoyeni & Pamela W. Duncan - 2018 - Journal of Medical Ethics 44 (8):560-566.
    Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical (...)
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  • Can and Should the Research–Therapy Distinction Be Maintained? Reflections in the Light of Innovative Last-Resort Treatment.Gert Helgesson - 2019 - Research Ethics 15 (2):1-14.
    It has been debated for quite some time among bioethicists and others whether or not the distinction between therapy and research in healthcare can and should be maintained. This paper tries to clarify what the disagreement is about, and argues that the distinction can be maintained in most, if not all, situations. However, even if it can be maintained, it does not necessarily follow that it should. It is argued here that there are good reasons to maintain the distinction both (...)
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  • Factors Affecting Willingness to Share Electronic Health Data Among California Consumers.Katherine K. Kim, Pamela Sankar, Machelle D. Wilson & Sarah C. Haynes - 2017 - BMC Medical Ethics 18 (1):25.
    Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers’ views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers’ willingness to share electronic health information for healthcare and research. (...)
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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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  • 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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  • 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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  • 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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  • No Big Data Without Small Data: Learning Health Care Systems Begin and End with the Individual Patient.José A. Sacristán & Tatiana Dilla - 2015 - Journal of Evaluation in Clinical Practice 21 (6):1014-1017.
  • Big Data and Health Research—The Governance Challenges in a Mixed Data Economy.Søren Holm & Thomas Ploug - 2017 - Journal of Bioethical Inquiry 14 (4):515-525.
    Denmark is a society that has already moved towards Big Data and a Learning Health Care System. Data from routine healthcare has been registered centrally for years, there is a nationwide tissue bank, and there are numerous other available registries about education, employment, housing, pollution, etcetera. This has allowed Danish researchers to study the link between exposures, genetics and diseases in a large population. This use of public registries for scientific research has been relatively uncontroversial and has been supported by (...)
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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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  • The Research‐Clinical Practice Distinction, Learning Health Systems, and Relationships.Howard Brody & Franklin G. Miller - 2013 - Hastings Center Report 43 (5):41-47.
  • 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 Is Not Enough: Earning Institutional Trustworthiness Through Knowledge Translation.Stephanie R. Morain, Nancy E. Kass & Ruth R. Faden - 2018 - American Journal of Bioethics 18 (4):31-34.
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  • When and Why Is Research Without Consent Permissible?Luke Gelinas, Alan Wertheimer & Franklin G. Miller - 2016 - Hastings Center Report 46 (2):35-43.
    The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others hold (...)
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  • 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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  • A Content Analysis of the Views of Genetics Professionals on Race, Ancestry, and Genetics.Sarah C. Nelson, Joon-Ho Yu, Jennifer K. Wagner, Tanya M. Harrell, Charmaine D. Royal & Michael J. Bamshad - forthcoming - Ajob Empirical Bioethics:1-13.
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  • The Hair Stylist, the Corn Merchant, and the Doctor: Ambiguously Altruistic.Lois Shepherd - 2014 - Journal of Law, Medicine and Ethics 42 (4):509-517.
    The medical profession has a tradition of presenting itself as exceptionally altruistic. This article challenges the idea that physicians are, or should be, more altruistic than other professionals or other people, and goes so far as to posit that even a professional aspiration of altruism can have negative consequences.
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  • Research or Clinical Care: What’s the Difference?Nina Hallowell - 2018 - Journal of Medical Ethics 44 (6):359-360.
    In 1979 the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research in the US delivered a set of guidelines for the ethical conduct of research on human research subjects.1 In developing these guidelines, subsequently known as The Belmont Report, the Commission was “...directed to consider: the boundaries between biomedical and behavioural research and the accepted and routine practice of medicine”; and outline a set of ethical principles which would specifically govern research activities. The Report notes (...)
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  • Where Did Informed Consent for Research Come From?Alexander Morgan Capron - 2018 - Journal of Law, Medicine and Ethics 46 (1):12-29.
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  • The Hair Stylist, the Corn Merchant, and the Doctor: Ambiguously Altruistic.Lois Shepherd - 2014 - Journal of Law, Medicine and Ethics 42 (4):509-517.
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  • Institutional Review Boards: A Flawed System of Risk Management.Simon N. Whitney - 2016 - Research Ethics 12 (4):182-200.
    Institutional Review Boards and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function – the management of risk – using a flawed theoretical and practical approach. At the time of the IRB system’s creation, risk management theory emphasized the suppression of risk. Since then, scholars of governance, studying the experience of business and government, have learned that we must distinguish (...)
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  • Incidental Findings in the Era of Whole Genome Sequencing?Erik Parens, Paul Appelbaum & Wendy Chung - 2013 - Hastings Center Report 43 (4):16-19.