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90Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging FieldJournal of Law, Medicine and Ethics 40 (4): 716-750. 2012.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 c…Read more
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36Genetic Research as Therapy: Implications of "Gene Therapy" for Informed ConsentJournal of Law, Medicine and Ethics 26 (1): 38-47. 1998.In March 1996, the General Accounting Office (GAO) issued the reportScientific 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 t…Read more
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27Genetic Research as Therapy: Implications of "Gene Therapy" for Informed ConsentJournal of Law, Medicine and Ethics 26 (1): 38-47. 1998.In March 1996, the General Accounting Office (GAO) issued the reportScientific 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 t…Read more
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7Out of This World: re-grounding justice through science fictionPerspectives in Biology and Medicine 66 (2): 284-298. 2023.ABSTRACT:Good science fiction can be a successful vehicle for portraying justice. Science fiction can stimulate moral imagination in much the same way as the most effective justice theories, connecting the world in which we live with a range of alternative futures deliberately and creatively made plausible. A selective examination of classic and recent science fiction stories and novels provides contextual framing for considering questions of climate justice, virtuous personal action in the face…Read more
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12Dobbs, the Intrusive State, and the Future of SolidarityCambridge Quarterly of Healthcare Ethics 32 (3): 344-356. 2023.The intrusive state has long viewed women as fetal containers. The Dobbs decision goes further, essentially causing women to vanish when fetuses are abstracted from their relationships to pregnant persons. The ways in which women are first controlled and then made invisible are clearly connected with the move from obedience to omission that has historically affected black Americans. When personal decisionmaking and participation in democracy are regarded as threats, those threatened restrict dec…Read more
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127Clarifying the Ethics and Oversight of Chimeric ResearchHastings Center Report 52 (S2): 2-23. 2022.This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. …Read more
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Faith in science : professional and public discourse on regenerative medicineIn Michael J. Hyde & James A. Herrick (eds.), After the genome: a language for our biotechnological future, Baylor University Press. 2013.
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12Othering and Health JusticePerspectives in Biology and Medicine 65 (4): 604-611. 2022.ABSTRACT:Bioethics needs to expand its vision. We must examine and interrogate the social and structural barriers that help traditionally privileged communities maintain minoritized groups as inherently inferior "others." Justice requires the field to look beyond the walls of hospitals, clinics, and medical academia to address and ameliorate the structural injustices that give rise to health disparities long before differential access to health services becomes an issue for underserved patients.…Read more
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10Bioethics reenvisioned: a path toward health justiceThe University of North Carolina Press. 2022.Bioethics needs an expanded moral vision. It is now time for bioethics to take full account of the problems of health disparities and structural injustice that are made newly urgent by the COVID-19 pandemic and the effects of climate change. Nancy M. P. King, Gail E. Henderson, and Larry R. Churchill make the case for a more social understanding and application of justice, a deeper humility in assessing expertise in bioethics consulting, a broader and more relevant research agenda, and greater a…Read more
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13DEI Is Not EnoughHastings Center Report 52 (3): 3-3. 2022.Hastings Center Report, Volume 52, Issue 3, Page 3-3, May–June 2022.
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19Research with Human Subjects: Humility and DeceptionIRB: Ethics & Human Research 40 (2): 12-14. 2018.
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11Assessing Benefits in Clinical Research: Why Diversity in Benefit Assessment Can Be RiskyIRB: Ethics & Human Research 25 (3): 1. 2003.
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16Beyond the Medical Model: Retooling Bioethics for the Work AheadAmerican Journal of Bioethics 21 (2): 53-55. 2021.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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12The Future of Bioethics: It Shouldn't Take a PandemicHastings Center Report 50 (3): 54-56. 2020.The Covid‐19 pandemic has concentrated bioethics attention on the “lifeboat ethics” of rationing and fair allocation of scarce medical resources, such as testing, intensive care unit beds, and ventilators. This focus drives ethics resources away from persistent and systemic problems—in particular, the structural injustices that give rise to health disparities affecting disadvantaged communities of color. Bioethics, long allied with academic medicine and highly attentive to individual decision‐ma…Read more
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1Pragmatism, Value, and Judgment in Medicine (review)Journal of Law, Medicine and Ethics 37 (1): 147-148. 2009.
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12Key Information in the New Common Rule: Can It Save Research Consent?Journal of Law, Medicine and Ethics 47 (2): 203-212. 2019.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 …Read more
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24No abstract
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23Who's Winning the IRB Wars? The Struggle for the Soul of Human ResearchPerspectives in Biology and Medicine 61 (3): 450-464. 2018.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 threatened by the erosion of th…Read more
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40Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trialJournal of Medical Ethics Recent Issues 44 (8): 560-566. 2018._341_ _Objectives: _In patients with multivessel disease both the detection of the culprit lesion and the exact allocation are important preconditions for sufficient treatment and improved outcome. In a vessel based approach the combination of quantitative coronary angiography and fractional flow reserve measured by a pressure wire should be advantageous compared to myocardial SPECT, as morphological and functional information is delivered simultaneously. Therefore our aim was to evaluate MS in …Read more
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18Genetic Research as Therapy: Implications of “Gene Therapy” for Informed ConsentJournal of Law, Medicine and Ethics 26 (1): 38-47. 1998.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 …Read more
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55Biodefense Research and the U.S. Regulatory Structure Whither Nonhuman Primate Moral Standing?Kennedy Institute of Ethics Journal 21 (3): 277-310. 2011.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 …Read more
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20Research Ethics: Reexamining Key ConcernsJournal of Law, Medicine and Ethics 40 (4): 865-866. 2012.
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16The Importance of Amicable and Productive DisagreementJournal of Medicine and Philosophy 40 (3): 286-288. 2015.
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