29 found
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Robert M. Nelson [30]Robert Meland Nelson [1]
  1.  79
    The Concept of Voluntary Consent.Robert M. Nelson, Tom Beauchamp, Victoria A. Miller, William Reynolds, Richard F. Ittenbach & Mary Frances Luce - 2011 - American Journal of Bioethics 11 (8):6-16.
    Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the (...)
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  2.  97
    Child assent and parental permission in pediatric research.Wilma C. Rossi, William Reynolds & Robert M. Nelson - 2003 - Theoretical Medicine and Bioethics 24 (2):131-148.
    Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent has been theparadigm for (...)
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  3.  44
    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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  4.  28
    Forgoing Medically Provided Nutrition and Hydration in Pediatric Patients.Lawrence J. Nelson, Cindy Hylton Rushton, Ronald E. Cranford, Robert M. Nelson, Jacqueline J. Glover & Robert D. Truog - 1995 - Journal of Law, Medicine and Ethics 23 (1):33-46.
    Discussion of the ethics of forgoing medically provided nutrition and hydration tends to focus on adults rather than infants and children. Many appellate court decisions address the legal propriety of forgoing medically provided nutritional support of adults, but only a few have ruled on pediatric cases that pose the same issue.The cessation of nutritional support is implemented most commonly for patients in a permanent vegetative state ). An estimated 4,000 to 10,000 American children are in the permanent vegetative state, compared (...)
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  5.  32
    We should reject passive resignation in favor of requiring the assent of younger children for participation in nonbeneficial research.Robert M. Nelson & William W. Reynolds - 2003 - American Journal of Bioethics 3 (4):11 – 13.
  6.  56
    A capacity-based approach for addressing ancillary care needs: implications for research in resource limited settings.Patricia L. Bright & Robert M. Nelson - 2012 - Journal of Medical Ethics 38 (11):672-676.
    A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...)
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  7.  30
    Right Job, Wrong Tool: A Commentary on Designing Clinical Trials for Ebola Virus Disease.Robert M. Nelson, Michelle Roth-Cline, Kevin Prohaska, Edward Cox, Luciana Borio & Robert Temple - 2015 - American Journal of Bioethics 15 (4):33-36.
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  8.  72
    Parent–Child Roles in Decision Making About Medical Research.Victoria A. Miller, William W. Reynolds & Robert M. Nelson - 2008 - Ethics and Behavior 18 (2-3):161 – 181.
    Our objective is to understand how parents and children perceive their roles in decision making about research participation. Forty-five children (ages 4-15 years) with or without a chronic condition and 21 parents were the participants. A semistructured interview assessed perceptions of up to 4 hypothetical research scenarios with varying levels of risk, benefit, and complexity. Children were also administered the Peabody Picture Vocabulary Test, Third Edition, to assess verbal ability, as a proxy for the child's cognitive development. The audiotaped interviews (...)
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  9.  32
    The Role of an Ethics Committee in Resolving Conflict in the Neonatal Intensive Care Unit.Robert M. Nelson & Robyn S. Shapiro - 1995 - Journal of Law, Medicine and Ethics 23 (1):27-32.
    What should be the role of an institutional ethics committee in resolving conflict concerning patient care decisions in the neonatal intensive care unit? This question takes on added importance in light of recent court decisions which suggest that IEC deliberations may serve as persuasive evidence in court, of proposed state regulations that would establish an IEC as an alternative to judicial review, and of recent Joint Commission on Accreditation of Healthcare Organizations guidelines that require an institutional policy on limitation or (...)
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  10.  16
    The Use of Pediatric Extrapolation to Avoid Unnecessary Pediatric Clinical Trials.Robert M. Nelson - 2020 - American Journal of Bioethics 20 (4):114-116.
    Volume 20, Issue 4, May 2020, Page 114-116.
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  11. Is there an objective way to compare research risks?John Rossi & Robert M. Nelson - 2012 - Journal of Medical Ethics 38 (7):423-427.
    Determining whether a research risk meets or exceeds a regulatory standard of risk acceptability is difficult. Recently a framework called the systematic evaluation of research risks (SERR) has been proposed as a method of comparing research risks with predetermined standards of acceptability. SERR purports to offer a systematic and largely determinate (definite) way to compare risks and say whether a specific research risk falls below or above an acknowledged standard of acceptable risk. Here the authors review some philosophical problems with (...)
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  12.  32
    A Relative Standard for Minimal Risk is Unnecessary and Potentially Harmful to Children: Lessons from the Phambili Trial.Robert M. Nelson - 2011 - American Journal of Bioethics 11 (6):14 - 16.
    The American Journal of Bioethics, Volume 11, Issue 6, Page 14-16, June 2011.
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  13.  44
    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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  14.  28
    Index to Volume 21.Howard Brody, Rita Charon, Tod Chambers, Mary Williams Clark, Dwight Davis, Richard Martinez, Robert M. Nelson & Mark J. Cherry - 1996 - Journal of Medicine and Philosophy 21:681-684.
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  15.  33
    What are healthcare ethics committees in wisconsin doing?Janet L. Schaffner & Robert M. Nelson - 1999 - HEC Forum 11 (3):247-253.
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  16. Rita Charon, Howard Brody, Mary Williams Clark.Dwight Davis, Richard Martinez & Robert M. Nelson - 1996 - Journal of Medicine and Philosophy 21:243-265.
     
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  17.  52
    Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies.Michelle Hume, Linda L. Lewis & Robert M. Nelson - 2017 - Journal of Medical Ethics 43 (12):857-860.
    The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs (...)
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  18.  31
    (1 other version)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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  19.  39
    Challenges in the Conduct of Emergency Research in Children: A Workshop Report.Robert M. Nelson - 2006 - American Journal of Bioethics 6 (6):W1-W9.
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  20.  27
    Institutional review boards lack the moral legitimacy to reinterpret subpart D.Robert M. Nelson - 2008 - American Journal of Bioethics 8 (4):37 – 39.
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  21.  29
    Nontherapeutic Research, Minimal Risk, and the Kennedy Krieger Lead Abatement Study.Robert M. Nelson - 2001 - IRB: Ethics & Human Research 23 (6):7.
  22.  31
    Protocol 126 and "The Hutch".Robert M. Nelson - 2001 - IRB: Ethics & Human Research 23 (3):14.
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  23.  57
    Response to Open Peer Commentaries on “The Concept of Voluntary Consent”.Robert M. Nelson & Tom L. Beauchamp - 2011 - American Journal of Bioethics 11 (8):W1-W3.
    The American Journal of Bioethics, Volume 11, Issue 8, Page W1-W3, August 2011.
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  24.  18
    SUPPORT: Risks, Harms, and Equipoise.Robert M. Nelson - 2015 - Hastings Center Report 45 (1):40-42.
    The debate about the ethics of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) often focuses on the assumptions made by the different parties involved, failing to note the lack of a necessary connection between those assumptions and the main criticism of the study—that the parents appear to have been poorly informed. The fact that the target ranges of oxygen saturation (SpO2) used in SUPPORT were within the range recommended as an appropriate “standard of care” does not mean that (...)
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  25.  22
    The Author Replies.Robert M. Nelson - 2015 - Hastings Center Report 45 (3):4-4.
    A response to “What Counts as Equipoise?” by Henry J. Silverman and Didier Dreyfuss.
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  26.  33
    Ethics Committees at Work.Pavel Tichtchenko, Jean C. Edmond, Robert M. Nelson, Ellen L. Blank, Robyn S. Shapiro & Charles Mackay - 1994 - Cambridge Quarterly of Healthcare Ethics 3 (4):602.
  27.  19
    A Framework for Evaluating a Minor's Involvement in Medical Decision Making.Donna L. Snyder & Robert M. Nelson - 2018 - American Journal of Bioethics 18 (3):10-12.
    Olszewski and Goldkind's (2018) article on pediatric decision making in the clinical care setting is articulate and well written. The authors understand the challenges in ensuring that pediatric pa...
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  28.  20
    The Food and Drug Administration’s Federal Review of a Pediatric Muscular Dystrophy Protocol.Donna L. Snyder & Robert M. Nelson - 2018 - IRB: Ethics & Human Research 40 (1):18-20.
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  29.  29
    Book Reviews: The Flight from Science and Reason, edited by Paul R. Gross, Norman Levitt, and Martin W. Lewis. NY: The New York Academy of Sciences, 1996. 593 pp. Paperback. [REVIEW]James M. Humber, Paul J. Millea & Robert M. Nelson - 1999 - Journal of Medical Humanities 20 (1):65-71.