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Susan Wolf
University of North Carolina, Chapel Hill
  1.  48
    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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  2.  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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  3.  1
    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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  4.  1
    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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  5.  1
    Return of Results in Participant-Driven Research: Learning From Transformative Research Models.Susan M. Wolf - 2020 - Journal of Law, Medicine and Ethics 48 (1_suppl):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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  6.  2
    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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  7. Confronting Physician Assisted Suicide and Euthanasia: My Father's Death.Susan M. Wolf - 2008 - Hastings Center Report 38 (5):pp. 23-26.
  8.  38
    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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  9.  65
    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.
    The nanomedicine field is fast evolving toward complex, “active,” and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted. Nanomedicine HSR provides an (...)
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  10.  24
    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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  11.  37
    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.
    As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations.
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  12.  28
    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.
    Research technologies can now produce so much information that there is signifcant potential for incidental fndings . These are fndings generated in research that are beyond the aims of the study. Current law and federal regulations ofer no direct guidance on how to deal with IFs in research, nor is there adequate professional or institutional guidance. We advocate a defned set of researcher duties based on law and ethics and recommend a pathway to be followed in handling IFs in research. (...)
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  13.  21
    The Challenge of Incidental Findings.Susan M. Wolf - 2008 - Journal of Law, Medicine and Ethics 36 (2):216-218.
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  14.  12
    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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  15.  43
    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.  21
    Beyond "Genetic Discrimination": Toward the Broader Harm of Geneticism.Susan M. Wolf - 1995 - Journal of Law, Medicine and Ethics 23 (4):345-353.
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  17.  19
    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.
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  18.  6
    Health Care Reform and the Future of Physician Ethics.Susan M. Wolf - 1994 - Hastings Center Report 24 (2):28-41.
  19.  7
    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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  20.  23
    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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  21.  30
    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.
  22.  6
    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.
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  23.  8
    Ethics Committees: In The Courts.Susan M. Wolf - 1986 - Hastings Center Report 16 (3):12-15.
  24.  83
    Neurolaw: The Big Question.Susan M. Wolf - 2008 - American Journal of Bioethics 8 (1):21 – 22.
  25.  3
    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.
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  26.  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.
  27.  47
    Due Process in Ethics Committee Case Review.Susan M. Wolf - 1992 - HEC Forum 4 (2):83-96.
  28.  9
    Holding the Line on Euthanasia.Susan M. Wolf - 1989 - Hastings Center Report 19 (1):13-15.
  29.  4
    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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  30.  33
    Bioethics Matures: The Field Faces the Future.Susan M. Wolf & Jeffrey P. Kahn - 2005 - Hastings Center Report 35 (4):22-24.
  31.  14
    Conflict Between Doctor and Patient.Susan M. Wolf - 1988 - Journal of Law, Medicine and Ethics 16 (3-4):197-203.
  32.  9
    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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  33.  9
    Ban Cloning? Why NBAC Is Wrong.Susan M. Wolf - 1997 - Hastings Center Report 27 (5):12-15.
  34.  9
    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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  35.  17
    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.
  36.  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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  37.  2
    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 (2_suppl):6-32.
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  38.  5
    Toward a Theory of Process.Susan M. Wolf - 1992 - Journal of Law, Medicine and Ethics 20 (4):278-290.
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  39.  14
    Law & Bioethics: From Values to Violence.Susan M. Wolf - 2004 - Journal of Law, Medicine and Ethics 32 (2):293-306.
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  40.  13
    Honoring Broader Directives.Susan M. Wolf - 1991 - Hastings Center Report 21 (5):8-16.
  41.  10
    Nancy Beth Cruzan: In No Voice At All.Susan M. Wolf - 1990 - Hastings Center Report 20 (1):38-41.
  42.  7
    Debating the Use of Racial and Ethnic Categories in Research.Susan M. Wolf - 2006 - Journal of Law, Medicine and Ethics 34 (3):483-486.
  43.  5
    Doing Ethics in Italy.Susan M. Wolf & Strachan Donnelley - 1988 - Hastings Center Report 18 (4):13-14.
  44.  9
    "Final Exit": The End of Argument.Susan M. Wolf - 1992 - Hastings Center Report 22 (1):30-33.
  45.  41
    Book Review:Surrogate Motherhood: Politics and Privacy. Larry Gostin. [REVIEW]Susan M. Wolf - 1992 - Ethics 102 (3):671-.
  46.  14
    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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  47.  17
    Letters.Leon R. Kass, Derek Humphry & Susan M. Wolf - 1992 - Hastings Center Report 22 (6):44-45.
  48.  10
    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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  49.  5
    The Challenge of Developing Oversight Approaches to Nanobiotechnology.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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  50.  7
    What Adrienne Knew:Living Bioethics.Susan M. Wolf - 2014 - Hastings Center Report 44 (2):17-19.
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