41 found
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  1.  13
    Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.Alex John London & Jonathan Kimmelman - 2019 - Hastings Center Report 49 (4):31-41.
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  2.  35
    Assessing Risk/Benefit for Trials Using Preclinical Evidence: A Proposal.Jonathan Kimmelman & Valerie Henderson - 2016 - Journal of Medical Ethics 42 (1):50-53.
  3.  43
    The Therapeutic Misconception at 25: Treatment, Research, and Confusion.Jonathan Kimmelman - 2007 - Hastings Center Report 37 (6):36-42.
    : "Therapeutic misconception" has been misconstrued, and some of the newer, mistaken interpretations are troublesome. They exaggerate the distinction between research and treatment, revealing problems in the foundations of research ethics and possibly weakening informed consent.
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  4.  12
    Predicting Harms and Benefits in Translational Trials: Ethics, Evidence, and Uncertainty.Jonathan Kimmelman & Alex John London - unknown
    First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...)
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  5.  15
    The Structure of Clinical Translation:Efficiency, Information, and Ethics.Jonathan Kimmelman & Alex John London - 2015 - Hastings Center Report 45 (2):27-39.
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  6. Patient-Funded Trials: Opportunity or Liability?Danielle M. Wenner, Alex John London & Jonathan Kimmelman - 2015 - Cell Stem Cell 17 (2):135-137.
    Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols.
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  7.  26
    Helsinki Discords: FDA, Ethics, and International Drug Trials.Jonathan Kimmelman, Charles Weijer & Eric M. Meslin - unknown
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  8. Extending Clinical Equipoise to Phase 1 Trials Involving Patients: Unresolved Problems.A. Anderson James & Kimmelman Jonathan - 2010 - Kennedy Institute of Ethics Journal 20 (1):75-98.
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  9.  28
    Do We Know Whether Researchers and Reviewers Are Estimating Risk and Benefit Accurately?Spencer Phillips Hey & Jonathan Kimmelman - 2016 - Bioethics 30 (8):609-617.
    Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach – forecast analysis – that would enable direct and (...)
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  10.  53
    Valuing Risk: The Ethical Review of Clinical Trial Safety.Jonathan Kimmelman - 2004 - Kennedy Institute of Ethics Journal 14 (4):369-393.
    : Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of the research. These views of risk conflict with scholarship showing that risk evaluations are socially (...)
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  11.  8
    Beyond Access Vs. Protection in Trials of Innovative Therapies.Alex John London, Jonathan Kimmelman & Marina Elena Emborg - unknown
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  12.  13
    Medical Research, Risk, and Bystanders.Jonathan Kimmelman - 2005 - IRB: Ethics & Human Research 27 (4):1.
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  13.  31
    The Risk-Escalation Model: A Principled Design Strategy for Early-Phase Trials.Spencer Phillips Hey & Jonathan Kimmelman - 2014 - Kennedy Institute of Ethics Journal 24 (2):121-139.
    Should first-in-human trials be designed to maximize the prospect of therapeutic benefit for volunteers, prioritize avoidance of unintended harms, or aim for some happy medium between the two? Perennial controversies surrounding initiation and design of early-phase trials hinge on how this question is resolved. In this paper, we build on the premise that the task of early-phase testing is to optimize various components of a potential therapy so that later, confirmatory trials have the maximal probability of informing drug development and (...)
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  14.  60
    Are Phase 1 Trials Therapeutic? Risk, Ethics, and Division of Labor.James A. Anderson & Jonathan Kimmelman - 2014 - Bioethics 28 (3):138-146.
    Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...)
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  15.  27
    Missing the Forest: Further Thoughts on the Ethics of Bystander Risk in Medical Research.Jonathan Kimmelman - 2007 - Cambridge Quarterly of Healthcare Ethics 16 (4):483.
    Developments in the last several years have sparked renewed interest in the ethics of research involving humans. Issues relating to the global extent of research and its guiding principles are of particular importance to researchers, health officials, and individual ethics committees who want a deeper and more encompassing inquire regarding the foundation and evolution of human research. This department of CQ launches a long overdue effort to explore these wider issues. Readers are invited to submit papers to Charles MacKay, 5011 (...)
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  16.  2
    Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.
    Many commentators have expressed concern that large investments in biomedical research over the past two decades have not been translated effectively into clinical applications. In its Critical Path Report, the Food and Drug Administration characterized the problem as a “technological disconnect between discovery and the product development process,” and documented that the number of investigational new drugs submitted to the agency had declined “significantly” since 2000. Along a similar vein, another study found that only five of 101 basic science studies (...)
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  17.  4
    What Research Ethics (Often) Gets Wrong About Minimal Risk.Patrick Bodilly Kane, Scott Y. H. Kim & Jonathan Kimmelman - 2020 - American Journal of Bioethics 20 (1):42-44.
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  18.  81
    The Ethics of Managing Affective and Emotional States to Improve Informed Consent: Autonomy, Comprehension, and Voluntariness.Hillel Braude & Jonathan Kimmelman - 2012 - Bioethics 26 (3):149-156.
    Over the past several decades the ‘affective revolution’ in cognitive psychology has emphasized the critical role affect and emotion play in human decision-making. Drawing on this affective literature, various commentators have recently proposed strategies for managing therapeutic expectation that use contextual, symbolic, or emotive interventions in the consent process to convey information or enhance comprehension. In this paper, we examine whether affective consent interventions that target affect and emotion can be reconciled with widely accepted standards for autonomous action. More specifically, (...)
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  19.  65
    Ethics, Ambiguity Aversion, and the Review of Complex Translational Clinical Trials.Jonathan Kimmelman - 2012 - Bioethics 26 (5):242-250.
    Clinical trials of novel agents often present several layers of ethical challenge. Because time and resources for ethical and safety review are limited, how investigators, IRBs, and regulators allocate attention to a trial's various safety dimensions itself represents a critical ethical question. In what follows, I use the example of a Parkinson's disease gene transfer trial to show how risks involving unknown probabilities or outcomes (ambiguity), might sometimes draw attention away from risks that involve known probabilities or outcomes. This potentially (...)
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  20.  4
    Ethics at Phase 0: Clarifying the Issues.Jonathan Kimmelman - 2007 - Journal of Law, Medicine and Ethics 35 (4):727-733.
    The Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products recently issued documents encouraging sponsors to consider microdose testing before launching Phase I trials, and many commentators predict that such methodologies will be applied more routinely in drug development. However, exploratory testing has provoked several ethical criticisms. Skeptics question the value and validity of microdose trials, and whether they present a reasonable balance of risks and benefits for subjects. Another major criticism is that such studies (...)
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  21. Analysis of Consent Validity for Invasive, Nondiagnostic Research Procedures.Jonathan Kimmelman, Trudo Lemmens & Scott Kim - 2012 - IRB: Ethics & Human Research 34 (5):1-7.
    A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We next (...)
     
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  22.  11
    How Do Researchers Decide Early Clinical Trials?Hannah Grankvist & Jonathan Kimmelman - 2016 - Medicine, Health Care and Philosophy 19 (2):191-198.
    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We (...)
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  23.  32
    Stem Cell Trials: Lessons From Gene Transfer Research.Jonathan Kimmelman, Françoise Baylis & Kathleen Cranley Glass - 2006 - Hastings Center Report 36 (1):23-26.
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  24.  13
    Risking Ethical Insolvency: A Survey of Trends in Criminal DNA Databanking.Jonathan Kimmelman - 2000 - Journal of Law, Medicine and Ethics 28 (3):209-221.
    Over ten years have elapsed since Virginia passed the nation's first criminal DNA banking law, which authorized law enforcement authorities to collect DNA samples from certain categories of offenders for the purposes of performing profile analysis. Within nine years, Rhode Island became the fiftieth state to enact a similar statute. The passage of a decade since the first enactment provides a convenient opportunity to assess the strengths and weaknesses of ethical safeguards under present law as well as predict the likely (...)
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  25.  17
    Clinical Trials and Scid Row: The Ethics of Phase 1 Trials in the Developing World.Jonathan Kimmelman - 2007 - Developing World Bioethics 7 (3):128–135.
    ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with (...)
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  26.  3
    Risking Ethical Insolvency: A Survey of Trends in Criminal DNA Databanking.Jonathan Kimmelman - 2000 - Journal of Law, Medicine and Ethics 28 (3):209-221.
    Over ten years have elapsed since Virginia passed the nation's first criminal DNA banking law, which authorized law enforcement authorities to collect DNA samples from certain categories of offenders for the purposes of performing profile analysis. Within nine years, Rhode Island became the fiftieth state to enact a similar statute. The passage of a decade since the first enactment provides a convenient opportunity to assess the strengths and weaknesses of ethical safeguards under present law as well as predict the likely (...)
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  27.  2
    Clinical Trials and Scid Row: The Ethics of Phase 1 Trials in the Developing World.Jonathan Kimmelman - 2007 - Developing World Bioethics 7 (3):128-135.
    ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied with (...)
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  28.  19
    Launching Invasive, First-in-Human Trials Against Parkinson’s Disease: Ethical Considerations.Jonathan Kimmelman, Alex John London, Bernard Ravina, Tim Ramsay, Mark Bernstein, Alan Fine, Frank W. Stahnisch & Marina Elena Emborg - unknown
    The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable riskbenefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We close (...)
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  29.  8
    Towards a Global Human Embryonic Stem Cell Bank: Differential Termination.Jonathan Kimmelman - 2007 - American Journal of Bioethics 7 (8):52 – 53.
  30.  5
    The Research Optimist's Defense.Daniel Benjamin & Jonathan Kimmelman - 2016 - Perspectives in Biology and Medicine 59 (4):491-506.
    Clinical researchers are commonly accused of being overconfident and overly optimistic. They are charged with overestimating their ability to recruit patients to trials and to end trials on time. They are also accused of overestimating effect sizes in power calculations, of overestimating the promise of new interventions, and of conveying this pronounced optimism to human research subjects. More broadly, medical scientists are accused of underestimating timelines for the maturation of research programs, or overstating the potential of their research to deliver (...)
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  31. Faisons mieux les choses : représentation publique de la science sur la COVID-19.Tania Bubela, Timothy Caulfield, Jonathan Kimmelman & Vardit Ravitsky - 2020 - Ottawa, Canada:
    Les recherches scientifiques sur la COVID-19 sont à la fois menées et diffusées à une cadence effrénée. Bien qu’il soit inspirant de voir la communauté de la recherche répondre avec autant de vigueur à la crise causée par la pandémie, toute cette activité a par ailleurs engendré un chaos de mauvaises données, de résultats contradictoires et de manchettes exagérées. Alors que la polarisation, la déformation et la médiatisation des résultats scientifiques s’intensifient chaque jour, les inquiétudes se font de plus en (...)
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  32. Let’s Do Better: Public Representations of COVID-19 Science.Tania Bubela, Timothy Caulfield, Jonathan Kimmelman & Vardit Ravitsky - 2020 - Ottawa, Canada:
    COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion (...)
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  33.  5
    Battling a Thousand Points of Might.Jonathan Kimmelman - 2009 - Hastings Center Report 39 (1):3-3.
  34.  19
    Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines.Jonathan Kimmelman - 2012 - Journal of Law, Medicine and Ethics 40 (4):841-847.
    Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine translation (...)
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  35.  14
    Beyond Human Subjects: Risk, Ethics, and Clinical Development of Nanomedicines.Jonathan Kimmelman - 2012 - Journal of Law, Medicine and Ethics 40 (4):841-847.
    Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of (...)
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  36. Twenty-Five Years of Therapeutic Misconception-Jonathan Kimmelman Replies.Jonathan Kimmelman - 2008 - Hastings Center Report 38 (2):6-7.
     
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  37.  3
    What Is Human Research For? Reflections on the Omission of Scientific Integrity From the Belmont Report.Jonathan Kimmelman - 2020 - Perspectives in Biology and Medicine 63 (2):251-261.
    The Belmont Report is a totem of human research ethics. Its principles have provided a sustained and organizing vision for human protections and have been endorsed by various subsequent human protections policies. Besides its influence, the Belmont Report rewards multiple reads and abounds in insights, many of which have been under-attended in research ethics. Above all, the principles articulated in Belmont have proven adaptable to the many novel research strategies, approaches, settings, and challenges that have emerged in the 40 years (...)
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  38.  4
    Why IRBs Should Protect Bystanders in Human Research.Jonathan Kimmelman - 2020 - Bioethics 34 (9):933-936.
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  39.  14
    Why Clinical Translation Cannot Succeed Without Failure.Alex John London & Jonathan Kimmelman - unknown
    The high rates of attrition that occur in drug development are widely regarded as problematic, but the failure of well-designed studies benefits both researchers and healthcare systems by, for example, generating evidence about disease theories and demonstrating the limits of proven drugs. A wider recognition of these benefits will help the biomedical research enterprise to take full advantage of all the information generated during the drug development process.
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  40.  8
    Introduction to the Special Issue on the Belmont Report.Franklin G. Miller & Jonathan Kimmelman - 2020 - Perspectives in Biology and Medicine 63 (2):219-219.
    The Belmont Report, issued in 1979 by the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, is a landmark document providing guidance on the ethics of research involving human subjects. It is divided into three sections: “Boundaries between practice and research; “Basic ethical principles” ; and “Applications of these principles with respect to informed consent, assessment of risks and benefits, and selection of subjects.”While the Belmont Report has enduring significance, the landscape of biomedical research (...)
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  41.  9
    Decision Analysis Approach to Risk/Benefit Evaluation in the Ethical Review of Controlled Human Infection Studies.Michael Yu, Thomas C. Darton & Jonathan Kimmelman - 2020 - Bioethics 34 (8):764-770.
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