8 found
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  1.  42
    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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  2.  7
    Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary.Laura M. Beskow, Catherine M. Hammack-Aviran, Kathleen M. Brelsford & P. Pearl O'Rourke - 2020 - Journal of Law, Medicine and Ethics 48 (S1):138-146.
    In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.
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  3.  8
    Clarifying the Ethics and Oversight of Chimeric Research.Josephine Johnston, Insoo Hyun, Carolyn P. Neuhaus, Karen J. Maschke, Patricia Marshall, Kaitlynn P. Craig, Margaret M. Matthews, Kara Drolet, Henry T. Greely, Lori R. Hill, Amy Hinterberger, Elisa A. Hurley, Robert Kesterson, Jonathan Kimmelman, Nancy M. P. King, Melissa J. Lopes, P. Pearl O'Rourke, Brendan Parent, Steven Peckman, Monika Piotrowska, May Schwarz, Jeff Sebo, Chris Stodgell, Robert Streiffer & Amy Wilkerson - 2022 - Hastings Center Report 52 (S2):2-23.
    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. Led by bioethics researchers working closely with an (...)
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  4.  12
    Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles.Laura M. Beskow & P. Pearl O'Rourke - 2015 - Journal of Law, Medicine and Ethics 43 (3):502-513.
    We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.
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  5.  15
    The Final Rule: When the Rubber Meets the Road.P. Pearl O'Rourke - 2017 - American Journal of Bioethics 17 (7):27-33.
    The Common Rule originally issued in 1991 and last amended in 2005 is scheduled to be replaced on January 19, 2018 by a revised Common Rule. The goal of the revisions is to modernize and improve applicability of the rule to a research landscape that has dramatically changed since 1991. Translating these changes into action will require comprehensive understanding of the final rule and detailed implementation planning by Human Research Protection Programs. This paper presents select changes that require substantial attention; (...)
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  6.  31
    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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  7.  6
    Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families.Conrad V. Fernandez, P. Pearl O'Rourke & Laura M. Beskow - 2015 - Journal of Law, Medicine and Ethics 43 (3):514-522.
    Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board chairs to this issue and their opinions as to the role of the REB in developing related policy.
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  8.  39
    Part-Human Animal Research: The Imperative to Move Beyond a Philosophical Debate.Melinda Abelman, P. Pearl O'Rourke & Kai C. Sonntag - 2012 - American Journal of Bioethics 12 (9):26-28.
    The American Journal of Bioethics, Volume 12, Issue 9, Page 26-28, September 2012.
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