32 found
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  1.  83
    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.  15
    Researcher Perspectives on Ethical Considerations in Adaptive Deep Brain Stimulation Trials.Katrina A. Muñoz, Kristin Kostick, Clarissa Sanchez, Lavina Kalwani, Laura Torgerson, Rebecca Hsu, Demetrio Sierra-Mercado, Jill O. Robinson, Simon Outram, Barbara A. Koenig, Stacey Pereira, Amy McGuire, Peter Zuk & Gabriel Lázaro-Muñoz - 2020 - Frontiers in Human Neuroscience 14.
  3.  22
    Researcher Views on Changes in Personality, Mood, and Behavior in Next-Generation Deep Brain Stimulation.Peter Zuk, Clarissa E. Sanchez, Kristin Kostick-Quenet, Katrina A. Muñoz, Lavina Kalwani, Richa Lavingia, Laura Torgerson, Demetrio Sierra-Mercado, Jill O. Robinson, Stacey Pereira, Simon Outram, Barbara A. Koenig, Amy L. McGuire & Gabriel Lázaro-Muñoz - 2023 - American Journal of Bioethics Neuroscience 14 (3):287-299.
    The literature on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises concerns that these technologies may affect personality, mood, and behavior. We conducted semi-structured interviews with researchers (n = 23) involved in developing next-generation DBS systems, exploring their perspectives on ethics and policy topics including whether DBS/aDBS can cause such changes. The majority of researchers reported being aware of personality, mood, or behavioral (PMB) changes in recipients of DBS/aDBS. Researchers offered varying estimates of the frequency of PMB changes. A (...)
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  4.  15
    Have We Asked Too Much of Consent?Barbara A. Koenig - 2014 - Hastings Center Report 44 (4):33-34.
    Paul Appelbaum and colleagues propose four models of informed consent to research that deploys whole genome sequencing and may generate incidental findings. They base their analysis on empirical data that suggests that research participants want to be offered incidental findings and on a normative consensus that researchers incur a duty to offer them. Their models will contribute to the heated policy debate about return of incidental findings. But in my view, they do not ask the foundational question, In the context (...)
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  5.  44
    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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  6.  57
    Introduction: Sharing Data in a Medical Information Commons.Amy L. McGuire, Mary A. Majumder, Angela G. Villanueva, Jessica Bardill, Juli M. Bollinger, Eric Boerwinkle, Tania Bubela, Patricia A. Deverka, Barbara J. Evans, Nanibaa' A. Garrison, David Glazer, Melissa M. Goldstein, Henry T. Greely, Scott D. Kahn, Bartha M. Knoppers, Barbara A. Koenig, J. Mark Lambright, John E. Mattison, Christopher O'Donnell, Arti K. Rai, Laura L. Rodriguez, Tania Simoncelli, Sharon F. Terry, Adrian M. Thorogood, Michael S. Watson, John T. Wilbanks & Robert Cook-Deegan - 2019 - Journal of Law, Medicine and Ethics 47 (1):12-20.
    Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
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  7.  14
    If you build it, they will come: unintended future uses of organised health data collections.Kieran C. O’Doherty, Emily Christofides, Jeffery Yen, Heidi Beate Bentzen, Wylie Burke, Nina Hallowell, Barbara A. Koenig & Donald J. Willison - 2016 - BMC Medical Ethics 17 (1):54.
    Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data (...)
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  8.  18
    The Role of Participants in a Medical Information Commons.Mary A. Majumder, Juli M. Bollinger, Angela G. Villanueva, Patricia A. Deverka & Barbara A. Koenig - 2019 - Journal of Law, Medicine and Ethics 47 (1):51-61.
    Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a “Medical Information Commons”. We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms. They also noted challenges including representation and perceived inefficiency, prompting reflection on political aspects of engagement and efficiency concerns.
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  9.  29
    Understanding the Practice of Ethics Consultation: Results of an Ethnographic Multi-Site Study.Susan E. Kelly, Patricia A. Marshall, Lee M. Sanders, Thomas A. Raffin & Barbara A. Koenig - 1997 - Journal of Clinical Ethics 8 (2):136-149.
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  10.  29
    Sequencing Newborns: A Call for Nuanced Use of Genomic Technologies.Josephine Johnston, John D. Lantos, Aaron Goldenberg, Flavia Chen, Erik Parens & Barbara A. Koenig - 2018 - Hastings Center Report 48 (S2):2-6.
    Many scientists and doctors hope that affordable genome sequencing will lead to more personalized medical care and improve public health in ways that will benefit children, families, and society more broadly. One hope in particular is that all newborns could be sequenced at birth, thereby setting the stage for a lifetime of medical care and self‐directed preventive actions tailored to each child's genome. Indeed, commentators often suggest that universal genome sequencing is inevitable. Such optimism can come with the presumption that (...)
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  11.  32
    Hopeful and Concerned: Public Input on Building a Trustworthy Medical Information Commons.Patricia A. Deverka, Dierdre Gilmore, Jennifer Richmond, Zachary Smith, Rikki Mangrum, Barbara A. Koenig, Robert Cook-Deegan, Angela G. Villanueva, Mary A. Majumder & Amy L. McGuire - 2019 - Journal of Law, Medicine and Ethics 47 (1):70-87.
    A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.
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  12.  17
    Characterizing the Biomedical Data-Sharing Landscape.Angela G. Villanueva, Robert Cook-Deegan, Barbara A. Koenig, Patricia A. Deverka, Erika Versalovic, Amy L. McGuire & Mary A. Majumder - 2019 - Journal of Law, Medicine and Ethics 47 (1):21-30.
    Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the data describe.
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  13.  23
    Researcher Perspectives on Data Sharing in Deep Brain Stimulation.Peter Zuk, Clarissa E. Sanchez, Kristin Kostick, Laura Torgerson, Katrina A. Muñoz, Rebecca Hsu, Lavina Kalwani, Demetrio Sierra-Mercado, Jill O. Robinson, Simon Outram, Barbara A. Koenig, Stacey Pereira, Amy L. McGuire & Gabriel Lázaro-Muñoz - 2020 - Frontiers in Human Neuroscience 14:578687.
    The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data (...)
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  14.  58
    The Difference That Culture Can Make in End-of-Life Decisionmaking.H. Eugene Hern, Barbara A. Koenig, Lisa Jean Moore & Patricia A. Marshall - 1998 - Cambridge Quarterly of Healthcare Ethics 7 (1):27-40.
    Cultural difference has been largely ignored within bioethics, particularly within the end-of-life discourses and practices that have developed over the past two decades in the U.S. healthcare system. Yet how should culturebe taken into account?
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  15.  21
    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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  16.  6
    “If relatives inherited the gene, they should inherit the data.” Bringing the family into the room where bioethics happens.Deborah R. Gordon & Barbara A. Koenig - 2022 - New Genetics and Society 41 (1):23-46.
    Biological kin share up to half of their genetic material, including predisposition to disease. Thus, variants of clinical significance identified in each individual’s genome can implicate an exponential number of relatives at potential risk. This has renewed the dilemma over family access to research participant’s genetic results, since prevailing US practices treat these as private, controlled by the individual. These individual-based ethics contrast with the family-based ethics – in which genetic information, privacy, and autonomy are considered to be familial – (...)
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  17.  18
    Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California.Sarah B. Garrett, Daniel Dohan & Barbara A. Koenig - 2015 - American Journal of Bioethics 15 (9):56-57.
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  18.  32
    Cultural Aspects of Nondisclosure.Celia J. Orona, Barbara A. Koenig & Anne J. Davis - 1994 - Cambridge Quarterly of Healthcare Ethics 3 (3):338.
    A basic assumption in current western medicine is that good healthcare involves informed choices. Indeed, making informed choices is not only viewed as “good practice” but a right to which each individual is entitled, a perspective only recently developed in the medical field.Moreover, in the case of ethical decisions, much of the discussion on the role of the family is cast within the autonomy paradigm of contemporary bioethics; that is, family members provide emotional support but do not make decisions for (...)
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  19.  34
    Sequencing Newborns: A Call for Nuanced Use of Genomic Technologies.Josephine Johnston, John D. Lantos, Aaron Goldenberg, Flavia Chen, Erik Parens, Barbara A. Koenig, Members of the Nsight Ethics & Policy Advisory Board - forthcoming - Zygon.
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  20.  10
    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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  21.  40
    AJOB Empirical Bioethics: A Home for Empirical Bioethics Scholarship.Chris Feudtner, Jeremy Sugarman, Barbara A. Koenig, Peter A. Ubel, Richard F. Ittenbach, Laura Weiss Roberts & Laurence B. McCullough - 2014 - AJOB Empirical Bioethics 5 (1):1-2.
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  22.  17
    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.
    Background: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands’ biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband’s results to family members, including after the proband’s death? Methods: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and nonbiological family members. (...)
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  23.  21
    Understanding variations in secondary findings reporting practices across U.S. genome sequencing laboratories.Sara L. Ackerman & Barbara A. Koenig - 2018 - AJOB Empirical Bioethics 9 (1):48-57.
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  24.  33
    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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  25.  24
    Informed Consent in a Multicultural Cancer Patient Population: implications for nursing practice.Donelle M. Barnes, Anne J. Davis, Tracy Moran, Carmen J. Portillo & Barbara A. Koenig - 1998 - Nursing Ethics 5 (5):412-423.
    Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients’ well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA’s cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast (...)
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  26.  11
    Why Not Grant Primacy to the Family?Barbara A. Koenig - 2001 - American Journal of Bioethics 1 (3):33-34.
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  27. Anthropology and bioethics.Barbara A. Koenig - 2003 - Cambridge Quarterly of Healthcare Ethics 7:68-76.
     
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  28.  3
    The Media and Behavioral Genetics: Alternatives Coexisting with Addiction Genetics.Barbara A. Koenig, Rachel Hammer, Jennifer B. McCormick, Jenny Ostergren & Molly J. Dingel - 2015 - Science, Technology, and Human Values 40 (4):459-486.
    To understand public discourse in the United States on genetic causation of behavioral disorders, we analyzed media representations of genetic research on addiction published between 1990 and 2010. We conclude first that the media simplistically represent biological bases of addiction and willpower as being mutually exclusive: behaviors are either genetically determined, or they are a choice. Second, most articles provide only cursory or no treatment of the environmental contribution. A media focus on genetics directs attention away from environmental factors. Rhetorically, (...)
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  29.  26
    Dead donors and the "shortage" of human organs: Are we missing the point?Barbara A. Koenig - 2003 - American Journal of Bioethics 3 (1):26 – 27.
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  30.  3
    How Ought Decisions That Weigh on Life and Death Be Justly Informed and Governed to Benefit More than the Privileged Few with Access to a Trusted Clinician?Barbara A. Koenig & Julia E. H. Brown - 2022 - American Journal of Bioethics 22 (2):1-3.
    The two target articles in this issue bring into focus the struggle for governance over biomedical interventions that may offer some families more agency—the capacity to act—in the context of many...
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  31.  8
    The Power (and Limits) of Proximity.Barbara A. Koenig - 1996 - Hastings Center Report 26 (6):30-32.
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  32.  16
    Systematic review of ethics consultation: A route to curriculum development in post-graduate medical education.Paul S. Mueller & Barbara A. Koenig - 2006 - American Journal of Bioethics 6 (4):21 – 23.
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