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Susan Wolf
University of North Carolina, Chapel Hill
  1.  41
    Ethical Challenges Arising in the COVID-19 Pandemic: An Overview From the Association of Bioethics Program Directors (ABPD) Task Force.Amy L. McGuire, Mark P. Aulisio, F. Daniel Davis, Cheryl Erwin, Thomas D. Harter, Reshma Jagsi, Robert Klitzman, Robert Macauley, Eric Racine, Susan M. Wolf, Matthew Wynia & Paul Root Wolpe - 2020 - American Journal of Bioethics 20 (7):15-27.
    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...
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  2.  58
    Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations.Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond - 2008 - Journal of Law, Medicine and Ethics 36 (2):219-248.
    No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...)
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  3.  45
    Feminism & Bioethics: Beyond Reproduction.Susan M. Wolf (ed.) - 1996 - Oxford University Press.
    Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...
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  4.  30
    Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.Susan M. Wolf, Rebecca Branum, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2015 - Journal of Law, Medicine and Ethics 43 (3):440-463.
    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 participant's death.
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  5.  44
    The Challenge of Informed Consent and Return of Results in Translational Genomics: Empirical Analysis and Recommendations.Gail E. Henderson, Susan M. Wolf, Kristine J. Kuczynski, Steven Joffe, Richard R. Sharp, D. Williams Parsons, Bartha M. Knoppers, Joon-Ho Yu & Paul S. Appelbaum - 2014 - Journal of Law, Medicine and Ethics 42 (3):344-355.
    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 Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...)
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  6.  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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  7.  5
    How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan & Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):44-68.
    Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.
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  8.  28
    Developing U.S. Oversight Strategies for Nanobiotechnology: Learning From Past Oversight Experiences.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Aliya Kuzhabekova, Alison W. Tisdale, Efrosini Kokkoli & Gurumurthy Ramachandran - 2009 - Journal of Law, Medicine and Ethics 37 (4):688-705.
    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 learn from assessment of the successes and failures of past oversight efforts aimed at (...)
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  9.  33
    The Law of Incidental Findings in Human Subjects Research: Establishing Researchers' Duties.Susan M. Wolf, Jordan Paradise & Charlisse Caga-Anan - 2008 - Journal of Law, Medicine and Ethics 36 (2):361-383.
    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. Neuroimaging scans may visualize the entire brain and (...)
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  10.  24
    The Challenge of Incidental Findings.Susan M. Wolf - 2008 - Journal of Law, Medicine and Ethics 36 (2):216-218.
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  11.  6
    Key Expert Stakeholder Perceptions of the Law of Genomics: Identified Problems and Potential Solutions.Fook Yee Cheung, Lauren Clatch, Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2020 - Journal of Law, Medicine and Ethics 48 (1):87-104.
    The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to (...)
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  12.  6
    Return of Results in Participant-Driven Research: Learning From Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (S1):159-166.
    Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.
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  13.  15
    Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including After Participant Death: Empirical Results From a Cancer Biobank.Carmen Radecki Breitkopf, Gloria M. Petersen, Susan M. Wolf, Kari G. Chaffee, Marguerite E. Robinson, Deborah R. Gordon, Noralane M. Lindor & Barbara A. Koenig - 2015 - Journal of Law, Medicine and Ethics 43 (3):464-475.
    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 relatives after their death.
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  14.  2
    From Genetics to Genomics: Facing the Liability Implications in Clinical Care.Gary Marchant, Mark Barnes, James P. Evans, Bonnie LeRoy & Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1):11-43.
    Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...)
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  15.  45
    Gene Therapy Oversight: Lessons for Nanobiotechnology.Susan M. Wolf, Rishi Gupta & Peter Kohlhepp - 2009 - Journal of Law, Medicine and Ethics 37 (4):659-684.
    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 Administration's Center for Biologics Evaluation and Research oversees human gene (...)
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  16.  28
    Beyond "Genetic Discrimination": Toward the Broader Harm of Geneticism.Susan M. Wolf - 1995 - Journal of Law, Medicine and Ethics 23 (4):345-353.
    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 inadequate to the task at hand. It (...)
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  17.  7
    The Continuing Evolution of Ethical Standards for Genomic Sequencing in Clinical Care: Restoring Patient Choice.Susan M. Wolf - 2017 - Journal of Law, Medicine and Ethics 45 (3):333-340.
    Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out (...)
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  18.  8
    The Past, Present, and Future of Informed Consent in Research and Translational Medicine.Susan M. Wolf, Ellen Wright Clayton & Frances Lawrenz - 2018 - Journal of Law, Medicine and Ethics 46 (1):7-11.
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  19.  14
    Should Researchers Offer Results to Family Members of Cancer Biobank Participants? A Mixed-Methods Study of Proband and Family Preferences.Deborah R. Gordon, Carmen Radecki Breitkopf, Marguerite Robinson, Wesley O. Petersen, Jason S. Egginton, Kari G. Chaffee, Gloria M. Petersen, Susan M. Wolf & Barbara A. Koenig - 2019 - AJOB Empirical Bioethics 10 (1):1-22.
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  20.  7
    Health Care Reform and the Future of Physician Ethics.Susan M. Wolf - 1994 - Hastings Center Report 24 (2):28-41.
  21.  2
    Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.Susan M. Wolf, Pilar N. Ossorio, Susan A. Berry, Henry T. Greely, Amy L. McGuire, Michelle A. Penny & Sharon F. Terry - 2020 - Journal of Law, Medicine and Ethics 48 (1):69-86.
    Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
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  22.  24
    Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants.Susan M. Wolf, Emily Scholtes, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Brian Van Ness & Benjamin S. Wilfond - 2018 - Journal of Law, Medicine and Ethics 46 (1):87-109.
    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 guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...)
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  23.  8
    Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research‐Clinical Divide.Susan M. Wolf, Wylie Burke & Barbara A. Koenig - 2015 - Journal of Law, Medicine and Ethics 43 (3):486-501.
    Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.
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  24.  10
    Ethics Committees: In The Courts.Susan M. Wolf - 1986 - Hastings Center Report 16 (3):12-15.
  25.  31
    Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues, Guidelines & Limits.Susan M. Wolf, Jeffrey P. Kahn & John E. Wagner - 2003 - Journal of Law, Medicine and Ethics 31 (3):327-339.
    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 and reduces the chance that the parents (...)
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  26.  20
    Toward An Expanded Vision of Clinical Ethics Education: From the Individual to the Institution.Mildred Z. Solomon, Bruce Jennings, Vivian Guilfoy, Rebecca Jackson, Lydia O'Donnell, Susan M. Wolf, Kathleen Nolan, Dieter Koch-Weser & Strachan Donnelley - 1991 - Kennedy Institute of Ethics Journal 1 (3):225-245.
  27.  11
    Holding the Line on Euthanasia.Susan M. Wolf - 1989 - Hastings Center Report 19 (1):13-15.
  28.  51
    Due Process in Ethics Committee Case Review.Susan M. Wolf - 1992 - HEC Forum 4 (2):83-96.
  29.  11
    The Professions: Public Interest and Common Good.Bruce Jennings, Daniel Callahan & Susan M. Wolf - 1987 - Hastings Center Report 17 (1):3-10.
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  30.  5
    International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access.Rebecca Branum & Susan M. Wolf - 2015 - Journal of Law, Medicine and Ethics 43 (3):576-593.
    Returning genetic research results to relatives raises complex issues. In order to inform the U.S. debate, this paper analyzes international law and policies governing the sharing of genetic research results with relatives and identifies key themes and lessons. The laws and policies from other countries demonstrate a range of approaches to balancing individual privacy and autonomy with family access for health benefit, offering important lessons for further development of approaches in the United States.
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  31.  14
    Conflict Between Doctor and Patient.Susan M. Wolf - 1988 - Journal of Law, Medicine and Ethics 16 (3-4):197-203.
  32.  6
    Toward a Theory of Process.Susan M. Wolf - 1992 - Journal of Law, Medicine and Ethics 20 (4):278-290.
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  33. Confronting Physician Assisted Suicide and Euthanasia: My Father's Death.Susan M. Wolf - 2008 - Hastings Center Report 38 (5):pp. 23-26.
  34.  83
    Neurolaw: The Big Question.Susan M. Wolf - 2008 - American Journal of Bioethics 8 (1):21 – 22.
  35.  16
    Genetic Testing and the Future of Disability Insurance: Ethics, Law & Policy.Susan M. Wolf & Jeffrey P. Kahn - 2007 - Journal of Law, Medicine and Ethics 35 (s2):6-32.
    Predictive genetic testing poses fundamental questions for disability insurance, a crucial resource funding basic needs when disability prevents income from work. This article, from an NIH-funded project, presents the first indepth analysis of the challenging issues: Should disability insurers be permitted to consider genetics and exclude predicted disability? May disabilities with a recognized genetic basis be excluded from coverage as pre-existing conditions? How can we assure that private insurers writing individual and group policies, employers, and public insurers deal competently and (...)
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  36.  6
    Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues, Guidelines & Limits.Susan M. Wolf, Jeffrey P. Kahn & John E. Wagner - 2003 - Journal of Law, Medicine and Ethics 31 (3):327-339.
    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 and reduces the chance that the parents (...)
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  37.  9
    Ban Cloning? Why NBAC Is Wrong.Susan M. Wolf - 1997 - Hastings Center Report 27 (5):12-15.
  38.  33
    Bioethics Matures: The Field Faces the Future.Susan M. Wolf & Jeffrey P. Kahn - 2005 - Hastings Center Report 35 (4):22-24.
  39.  3
    Genetic Testing and the Future of Disability Insurance: Ethics, Law & Policy.Susan M. Wolf & Jeffrey P. Kahn - 2007 - Journal of Law, Medicine and Ethics 35 (S2):6-32.
    Genetic testing poses fundamental questions for insurance. Testing can predict a low probability of future illness and disability, which can help promote the insurability of individuals with a family history of genetic risk, but it can also invite insurers to reject applicants, increase premiums, exclude people with certain illnesses and disabilities, and otherwise adjust the underwriting processes for individuals with certain genotypes. In the workplace, these issues may cause employers who offer or pay for insurance to alter their hiring behavior, (...)
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  40.  23
    The Challenge of Nanomedicine Human Subjects Research: Protecting Participants, Workers, Bystanders, and the Environment.Susan M. Wolf - 2012 - Journal of Law, Medicine and Ethics 40 (4):712-715.
  41.  10
    Incidental Findings in CT Colonography: Literature Review and Survey of Current Research Practice.Hassan Siddiki, J. G. Fletcher, Beth McFarland, Nora Dajani, Nicholas Orme, Barbara Koenig, Marguerite Strobel & Susan M. Wolf - 2008 - Journal of Law, Medicine and Ethics 36 (2):320-331.
    Incidental fndings of potential medical signifcance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography colonography studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defned plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical signifcance will be detected and reported in CTC research studies.
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  42.  3
    INTRODUCTION: Return of Research Results: What About the Family?Susan M. Wolf - 2015 - Journal of Law, Medicine and Ethics 43 (3):437-439.
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  43.  1
    Clinical, Ethical, and Legal Issues in Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor.Susan M. Wolf, Jeffrey P. Kahn & John E. Wagner - 2003 - Journal of Law, Medicine and Ethics 31 (3):327-39.
    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 and reduces the chance that the parents (...)
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  44.  17
    Law & Bioethics: From Values to Violence.Susan M. Wolf - 2004 - Journal of Law, Medicine and Ethics 32 (2):293-306.
    Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. (...)
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  45.  14
    Honoring Broader Directives.Susan M. Wolf - 1991 - Hastings Center Report 21 (5):8-16.
  46.  10
    Nancy Beth Cruzan: In No Voice At All.Susan M. Wolf - 1990 - Hastings Center Report 20 (1):38-41.
  47.  15
    Introduction.Jordan Paradise, Susan M. Wolf, Jennifer Kuzma, Gurumurthy Ramachandran & Efrosini Kokkoli - 2009 - Journal of Law, Medicine and Ethics 37 (4):543-545.
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  48.  5
    Doing Ethics in Italy.Susan M. Wolf & Strachan Donnelley - 1988 - Hastings Center Report 18 (4):13-14.
  49.  8
    Debating the Use of Racial and Ethnic Categories in Research.Susan M. Wolf - 2006 - Journal of Law, Medicine and Ethics 34 (3):483-486.
    Debate over the proper use of racial and ethnic categories in biomedical research has raged in recent years. With the Human Genome Project showing that human beings are overwhelmingly alike genetically, exhibiting more genetic variation within supposed “races” than between them, many have come to doubt the scientific utility of such categories. Yet federal authorities use Directive 15 from the Office of Management and Budget to mandate the continued use of such categories in research. Moreover, researchers studying health disparities argue (...)
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  50.  10
    "Final Exit": The End of Argument.Susan M. Wolf - 1992 - Hastings Center Report 22 (1):30-33.
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