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  1.  20
    Defining and Describing Benefit Appropriately in Clinical Trials.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28 (4):332-343.
    Institutional review boards and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction (...)
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  2.  7
    Key Information in the New Common Rule: Can It Save Research Consent?Nancy M. P. King - 2019 - Journal of Law, Medicine and Ethics 47 (2):203-212.
    Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and (...)
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  3.  73
    Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field.Leili Fatehi, Susan M. Wolf, Jeffrey McCullough, Ralph Hall, Frances Lawrenz, Jeffrey P. Kahn, Cortney Jones, Stephen A. Campbell, Rebecca S. Dresser, Arthur G. Erdman, Christy L. Haynes, Robert A. Hoerr, Linda F. Hogle, Moira A. Keane, George Khushf, Nancy M. P. King, Efrosini Kokkoli, Gary Marchant, Andrew D. Maynard, Martin Philbert, Gurumurthy Ramachandran, Ronald A. Siegel & Samuel Wickline - 2012 - Journal of Law, Medicine and Ethics 40 (4):716-750.
    Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...)
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  4.  5
    The Future of Bioethics: It Shouldn't Take a Pandemic.Larry R. Churchill, Nancy M. P. King & Gail E. Henderson - 2020 - Hastings Center Report 50 (3):54-56.
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  5.  26
    RAC Oversight of Gene Transfer Research: A Model Worth Extending?Nancy M. P. King - 2002 - Journal of Law, Medicine and Ethics 30 (3):381-389.
    Clinical gene transfer research has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee. This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.Clinical GTR is governed by the same (...)
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  6.  15
    Athletes Are Guinea Pigs.Nancy M. P. King & Richard Robeson - 2013 - American Journal of Bioethics 13 (10):13 - 14.
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  7.  4
    Beyond the Medical Model: Retooling Bioethics for the Work Ahead.Nancy M. P. King, Gail E. Henderson & Larry R. Churchill - 2021 - American Journal of Bioethics 21 (2):53-55.
    The three important target articles make a strong case for regarding racism as a public health crisis. Each calls for advocacy by the bi...
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  8.  16
    An Open Letter to Institutional Review Boards Considering Northfield Laboratories' Polyheme® Trial.Ken Kipnis, Nancy M. P. King & Robert M. Nelson - 2006 - American Journal of Bioethics 6 (3):18 – 21.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...)
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  9.  48
    Athlete or Guinea Pig? Sports and Enhancement Research.Nancy M. P. King & Richard Robeson - 2007 - Studies in Ethics, Law, and Technology 1 (1).
  10.  7
    Consent Forms and the Therapeutic Misconception.Nancy M. P. King, Gail E. Henderson, Larry R. Churchill, Arlene M. Davis, Sara Chandros Hull, Daniel K. Nelson, P. Christy Parham-Vetter, Barbra Bluestone Rothschild, Michele M. Easter & Benjamin S. Wilfond - 2005 - IRB: Ethics & Human Research 27 (1):1-7.
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  11.  11
    Genetic Research as Therapy: Implications of “Gene Therapy” for Informed Consent.Larry R. Churchill, Myra L. Collins, Nancy M. P. King, Stephen G. Pemberton & Keith A. Wailoo - 1998 - Journal of Law, Medicine and Ethics 26 (1):38-47.
    In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always clear (...)
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  12.  24
    Conscience, Courage, and “Consent”.Mark A. Hall & Nancy M. P. King - 2016 - Hastings Center Report 46 (2):30-32.
    On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...)
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  13.  35
    Vulnerability to Influence: A Two-Way Street.Gail E. Henderson, Arlene M. Davis & Nancy M. P. King - 2004 - American Journal of Bioethics 4 (3):50 – 52.
  14.  11
    Experimental Treatment Oxymoron or Aspiration?Nancy M. P. King - 1995 - Hastings Center Report 25 (4):6-15.
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  15.  32
    What Research Ethics Should Learn From Genomics and Society Research: Lessons From the ELSI Congress of 2011.Gail E. Henderson, Eric T. Juengst, Nancy M. P. King, Kristine Kuczynski & Marsha Michie - 2012 - Journal of Law, Medicine and Ethics 40 (4):1008-1024.
    In much the same way that genomic technologies are changing the complexion of biomedical research, the issues they generate are changing the agenda of IRBs and research ethics. Many of the biggest challenges facing traditional research ethics today — privacy and confidentiality of research subjects; ownership, control, and sharing of research data; return of results and incidental findings; the relevance of group interests and harms; the scope of informed consent; and the relative importance of the therapeutic misconception — have become (...)
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  16.  46
    Loss of Possession: Concussions, Informed Consent, and Autonomy.Richard Robeson & Nancy M. P. King - 2014 - Journal of Law, Medicine and Ethics 42 (3):334-343.
    The principle of informed consent is so firmly established in bioethics and biomedicine that the term was soon bowdlerized in common practice, such that engaging in the informed decision-making process with patients or research subjects is now often called “consenting” them. This evolution, from the original concept to the rather questionable coinage that makes consent a verb, reveals not only a loss of rhetorical precision but also a fundamental shift in the potential meaning, value, and implementation of the informed consent (...)
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  17.  23
    Nanomedicine First-in-Human Research: Challenges for Informed Consent.Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):823-830.
    First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent form (...)
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  18.  28
    Who Ate the Apple? A Commentary on the Core Competencies Report.Nancy M. P. King - 1999 - HEC Forum 11 (2):170-175.
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  19.  13
    The Importance of Amicable and Productive Disagreement.Nancy M. P. King - 2015 - Journal of Medicine and Philosophy 40 (3):286-288.
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  20.  22
    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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  21.  36
    Biodefense Research and the U.S. Regulatory Structure Whither Nonhuman Primate Moral Standing?L. Walker Rebecca & M. P. King Nancy - 2011 - Kennedy Institute of Ethics Journal 21 (3):277-310.
    Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease, suffering, and death arising, or potentially arising, from natural outbreaks or intentional deployment of some of the world’s most dreaded pathogens. Top priority research goals include finding vaccines to prevent, diagnostic tools to detect, and medicines for smallpox, plague, ebola, anthrax, tularemia, and viral hemorrhagic fevers, among many other pathogens (National Institute of Allergy and Infectious Diseases [NIAID] priority pathogens). To this end, increased funding for conducting (...)
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  22.  19
    The Ethics Committee as Greek Chorus.Nancy M. P. King - 1996 - HEC Forum 8 (6):346-354.
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  23.  9
    Response to Open Peer Commentaries on “An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial”: The Emergency Exception and Unproven/Unsatisfactory Treatment.Ken Kipnis, Nancy M. P. King & Robert M. Nelson - 2006 - American Journal of Bioethics 6 (3):W49-W50.
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  24.  59
    Dying Made Legal: New Challenge for Advance Directives. [REVIEW]Nancy M. P. King - 1991 - HEC Forum 3 (4):187-199.
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  25.  15
    Accident & Desire: Inadvertent Germline Effects in Clinical Research.Nancy M. P. King - 2003 - Hastings Center Report 33 (2):23-30.
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  26.  14
    Transparency in Neonatal Intensive Care.Nancy M. P. King - 1992 - Hastings Center Report 22 (3):18-25.
  27. Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be Risky.Larry R. Churchill, Daniel K. Nelson, Gail E. Henderson, Nancy M. P. King, Arlene M. Davis, Erin Leahey & Benjamin S. Wilfond - 2003 - IRB: Ethics & Human Research 25 (3):1.
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  28. The Physician as Captain of the Ship a Critical Reappraisal.Alan W. Cross, Larry R. Churchill & Nancy M. P. King - 1987
     
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  29.  16
    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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  30.  49
    Protection of Human Subjects and Scientific Progress: Can the Two Be Reconciled?Kathleen Cranley Glass, David B. Resnik, Stephen Olufemi Sodeke, Halley S. Faust, Rebecca Dresser, Nancy M. P. King, C. D. Herrera, David Orentlicher & Lynn A. Jansen - 2006 - Hastings Center Report 36 (1):4-9.
  31. Studying Benefit in Gene Transfer Research.Gail E. Henderson & Nancy M. P. King - 2001 - IRB: Ethics & Human Research 23 (2):13.
  32.  36
    Bad Blood Thirty Years Later: A Q&A with James H. Jones.James H. Jones & Nancy M. P. King - 2012 - Journal of Law, Medicine and Ethics 40 (4):867-872.
    Historian James H. Jones published the first edition of Bad Blood, the definitive history of the Tuskegee Syphilis Experiment, in 1981. Its clear-eyed examination of that research and its implications remains a bioethics classic, and the 30-year anniversary of its publication served as the impetus for the reexamination of research ethics that this symposium presents. Recent revelations about the United States Public Health Service study that infected mental patients and prisoners in Guatemala with syphilis in the late 1940s in order (...)
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  33. Advance Care Planning and End-of-Life Decision-Making.Nancy M. P. King & John C. Moskop - 2012 - In D. Micah Hester & Toby Schonfeld (eds.), Guidance for Healthcare Ethics Committees. Cambridge University Press.
     
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  34.  19
    Benefits, Harms, and Motives in Clinical Research.Nancy M. P. King - 2009 - Hastings Center Report 39 (4):3-3.
  35. Bioethics, Public Moral Argument, and Social Responsibility.Nancy M. P. King & Michael J. Hyde (eds.) - 2011 - Routledge.
    _Bioethics, Public Moral Argument, and Social Responsibility_ explores the role of democratically oriented argument in promoting public understanding and discussion of the benefits and burdens of biotechnological progress. The contributors examine moral and policy controversies surrounding biomedical technologies and their place in American society, beginning with an examination of discourse and moral authority in democracy, and addressing a set of issues that include: dignity in health care; the social responsibilities of scientists, journalists, and scholars; and the language of genetics and (...)
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  36.  3
    Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers, Written by Henry S. Richardson.Nancy M. P. King - 2015 - Journal of Moral Philosophy 12 (6):787-789.
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  37. Not for Distribution.Nancy M. P. King - 2000 - Journal of Law, Medicine and Ethics 28:332-343.
     
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  38.  5
    Perspective: The Stories We Tell Ourselves.Nancy M. P. King - 2003 - Hastings Center Report 33 (5).
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  39.  16
    Research Ethics: Reexamining Key Concerns.Nancy M. P. King & Ana S. Iltis - 2012 - Journal of Law, Medicine and Ethics 40 (4):865-866.
  40.  11
    Reviews in Medical Ethics.Nancy M. P. King - 2009 - Journal of Law, Medicine and Ethics 37 (1):147-148.
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  41. Research with Human Subjects:Humility and Deception.Nancy M. P. King - 2018 - IRB: Ethics & Human Research 40 (2):12-14.
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  42.  18
    Shaping Our Selves: On Technology, Flourishing, and a Habit of Thinking by Erik Parens.Nancy M. P. King - 2016 - Kennedy Institute of Ethics Journal 26 (1):5-10.
    In Shaping Our Selves, Erik Parens offers both a personal history of bioethics and a cleverly clarifying lens to train on disputes in bioethics about emerging technologies. The question for readers is whether this lens, as useful as it is, leaves too much outside our field of vision. Parens, born in 1957, comes from the first wave of bioethics scholars—those of us who still mostly happened into bioethics as a field, before it was sufficiently well-established to be identified as a (...)
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  43. The Glass House : Assessing Bioethics.Nancy M. P. King - 2007 - In Lisa A. Eckenwiler & Felicia Cohn (eds.), The Ethics of Bioethics: Mapping the Moral Landscape. Johns Hopkins University Press.
     
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  44.  4
    The Stories We Tell Ourselves.Nancy M. P. King - 2003 - Hastings Center Report 33 (5):48-48.
  45.  20
    Who's Winning the IRB Wars? The Struggle for the Soul of Human Research.Nancy M. P. King - 2018 - Perspectives in Biology and Medicine 61 (3):450-464.
    One of my favorite bioethics quotes is nearing 50 years old:Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be (...)
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  46.  22
    An Open Letter to Institutional Review Boards Considering Northfield Laboratories' PolyHeme® Trial.Robert M. Nelson, Nancy M. P. King & Ken Kipnis - 2010 - American Journal of Bioethics 10 (10):5-8.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme?, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme? and saline in the field and, still without consent, randomized between PolyHeme? and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...)
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