-
88Recommendations 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
-
79Feminism & bioethics: beyond reproduction (edited book)Oxford University Press. 1996.Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...
-
75Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task ForceAmerican Journal of Bioethics 20 (7): 15-27. 2020.The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing p...
-
67Moral Judges and Human IdealsPhilosophy and Phenomenological Research 55 (4): 957-962. 1995.Developing a vision of morality that is at once compelling and comprehensive is an enormous task. The questions and answers all interlock, making it difficult to know where to start. Most of us, I think, just jump in, with whatever issue or controversy grabs us. We make what headway we can with the section of the moral puzzle on which we choose to work and hope or trust that when we or others work on other sections, the results will fit smoothly, consistently, even supportively with our current …Read more
-
63Gene Therapy Oversight: Lessons for NanobiotechnologyJournal of Law, Medicine and Ethics 37 (4): 659-684. 2009.Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug A…Read more
-
60The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and RecommendationsJournal of Law, Medicine and Ethics 42 (3): 344-355. 2014.Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human G…Read more
-
52Returning a Research Participant's Genomic Results to Relatives: Analysis and RecommendationsJournal of Law, Medicine and Ethics 43 (3): 440-463. 2015.Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the …Read more
-
44What Has Covid‐19 Exposed in Bioethics? Four MythsHastings Center Report 51 (3): 3-4. 2021.The Covid‐19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning,…Read more
-
42Beyond "Genetic Discrimination": Toward the Broader Harm of GeneticismJournal of Law, Medicine and Ethics 23 (4): 345-353. 1995.The current explosion of genetic knowledge and the rapid proliferation of genetic tests has rightly provoked concern that we are approaching a future in which people will be labeled and disadvantaged based on genetic information. Indeed, some have already suffered harm, including denial of health insurance. This concern has prompted an outpouring of analysis. Yet almost all of it approaches the problem of genetic disadvantage under the rubric of “genetic discrimination.”This rubric is woefully i…Read more
-
42Book Review:Surrogate Motherhood: Politics and Privacy. Larry Gostin (review)Ethics 102 (3): 671-. 1992.
-
42Addressing the Ethical Challenges in Genetic Testing and Sequencing of ChildrenAmerican Journal of Bioethics 14 (3): 3-9. 2014.American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision m…Read more
-
40Bioethics Matures: The Field Faces the Future (review)Hastings Center Report 35 (4): 22-24. 2012.
-
40The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' DutiesJournal of Law, Medicine and Ethics 36 (2): 361-383. 2008.Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroima…Read more
-
39Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight ExperiencesJournal of Law, Medicine and Ethics 37 (4): 688-705. 2009.The emergence of nanotechnology, and specifically nanobiotechnology, raises major oversight challenges. In the United States, government, industry, and researchers are debating what oversight approaches are most appropriate. Among the federal agencies already embroiled in discussion of oversight approaches are the Food and Drug Administration , Environmental Protection Agency , Department of Agriculture , Occupational Safety and Health Administration , and National Institutes of Health . All can…Read more
-
37Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues, Guidelines & limitsJournal of Law, Medicine and Ethics 31 (3): 327-339. 2003.Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo an…Read more
-
37Toward An Expanded Vision of Clinical Ethics Education: From the Individual to the InstitutionKennedy Institute of Ethics Journal 1 (3): 225-245. 1991.This paper advances a new paradigm in clinical ethics education that not only emphasizes development of individual cli but also focuses on the institutional context within which health care professionals work. This approach has been applied to the goal of improving the care provided to critically and terminally ill adults. The model has been adopted by about thirty hospitals and nursing homes; additional institutions will soon join the program, entitled Decisions Near the End of Life. Here, we d…Read more
-
36Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research ParticipantsJournal of Law, Medicine and Ethics 46 (1): 87-109. 2018.Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and gui…Read more
-
35Multiculturalism and "The Politics of Recognition"Hastings Center Report 24 (5): 44. 1994.Multiculturalism and “The Politics of Recognition.” An Essay by Charles Taylor with commentary by Amy Gutmann, editor, Steven C. Rockefeller, Michael Walzer, and Susan Wolf.
-
31The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the EnvironmentJournal of Law, Medicine and Ethics 40 (4): 712-715. 2012.
-
28Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues, Guidelines & LimitsJournal of Law, Medicine and Ethics 31 (3): 327-339. 2003.Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo an…Read more
-
27The Ethical Primate (review)Philosophical Review 106 (1): 131-133. 1997.This short, readable book, aimed at a popular audience, is concerned to show that a naturalistic view of humankind can be reconciled with a commitment to morality and a belief in human freedom.
-
27Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including after Participant Death: Empirical Results from a Cancer BiobankJournal of Law, Medicine and Ethics 43 (3): 464-475. 2015.Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with…Read more
Chapel Hill, North Carolina, United States of America
Areas of Interest
Philosophy of Action |
Normative Ethics |