21 found
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  1.  13
    Exploring Understanding of “Understanding”: The Paradigm Case of Biobank Consent Comprehension.Laura M. Beskow & Kevin P. Weinfurt - 2019 - American Journal of Bioethics 19 (5):6-18.
    Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...)
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  2.  6
    Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.Mark A. Rothstein, John T. Wilbanks, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Megan Doerr, Barbara J. Evans, Catherine M. Hammack-Aviran, Michelle L. McGowan & Stacey A. Tovino - 2020 - Journal of Law, Medicine and Ethics 48 (S1):196-226.
    Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...)
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  3.  25
    Informed Consent in Translational Genomics: Insufficient Without Trustworthy Governance.Wylie Burke, Laura M. Beskow, Susan Brown Trinidad, Stephanie M. Fullerton & Kathleen Brelsford - 2018 - Journal of Law, Medicine and Ethics 46 (1):79-86.
    Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.
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  4.  11
    Thought Leader Perspectives on Participant Protections in Precision Medicine Research.Catherine M. Hammack, Kathleen M. Brelsford & Laura M. Beskow - 2019 - Journal of Law, Medicine and Ethics 47 (1):134-148.
    Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures (...)
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  5.  30
    Patients' Views Concerning Research on Medical Practices: Implications for Consent.Kevin P. Weinfurt, Juli M. Bollinger, Kathleen M. Brelsford, Travis J. Crayton, Rachel J. Topazian, Nancy E. Kass, Laura M. Beskow & Jeremy Sugarman - 2016 - Ajob Empirical Bioethics 7 (2):76-91.
  6.  4
    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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  7.  4
    Ethical Considerations in the Conduct of Unregulated mHealth Research: Expert Perspectives.Catherine M. Hammack-Aviran, Kathleen M. Brelsford & Laura M. Beskow - 2020 - Journal of Law, Medicine and Ethics 48 (S1):9-36.
    To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.
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  8.  10
    Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice.Leslie E. Wolf, Mayank J. Patel, Brett A. Williams Tarver, Jeffrey L. Austin, Lauren A. Dame & Laura M. Beskow - 2015 - Journal of Law, Medicine and Ethics 43 (3):594-609.
    The federal Certificate of Confidentiality plays an important role in research on sensitive topics by authorizing researchers to refuse to disclose identifiable research data in response to subpoenas in any legal setting. However, there is little known about how effective Certificates are in practice. This article draws on our legal and empirical research on this topic to fill this information gap. It includes a description of the purpose of Certificates, their legislative and regulatory history, and a summary of the few (...)
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  9.  5
    Consent for Acute Care Research and the Regulatory “Gray Zone”.Laura M. Beskow, Christopher J. Lindsell & Todd W. Rice - 2020 - American Journal of Bioethics 20 (5):26-28.
    Volume 20, Issue 5, June 2020, Page 26-28.
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  10.  26
    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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  11.  23
    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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  12.  12
    Points to Consider: The Research Ethics Consultation Service and the IRB.Laura M. Beskow, Christine Grady, Ana S. Iltis, John Z. Sadler & Benjamin S. Wilfond - 2009 - IRB: Ethics & Human Research 31 (6):1.
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  13.  7
    Considering the Nature of Individual Research Results.Laura M. Beskow - 2006 - American Journal of Bioethics 6 (6):38 – 40.
  14.  5
    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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  15.  5
    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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  16.  15
    IRB Chairs' Perspectives on Genotype-Driven Research Recruitment.Laura M. Beskow, Emily E. Namey, Patrick R. Miller, Daniel K. Nelson & Alexandra Cooper - 2012 - IRB: Ethics & Human Research 34 (3):1.
    Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S. institutional review board chairs concerning the acceptability of recontacting genetic research participants about additional research and their views on the disclosure of individual genetic results as part of recruitment. Our findings suggest there is (...)
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  17.  9
    Genotype-Driven Recruitment and the Disclosure of Individual Research Results.Laura M. Beskow - 2017 - American Journal of Bioethics 17 (4):64-65.
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  18.  31
    Research Participants’ Understanding of and Reactions to Certificates of Confidentiality.Laura M. Beskow, Devon K. Check & Natalie Ammarell - 2014 - Ajob Empirical Bioethics 5 (1):12-22.
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  19.  4
    Research Use of Electronic Health Records: Patients’ Views on Alternative Approaches to Permission.Catherine M. Hammack-Aviran, Kathleen M. Brelsford, Kevin C. McKenna, Ross D. Graham, Zachary M. Lampron & Laura M. Beskow - 2020 - AJOB Empirical Bioethics 11 (3):172-186.
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  20.  5
    Legal and Ethical Challenges of International Direct-to-Participant Genomic Research: Conclusions and Recommendations.Mark A. Rothstein, Ma'N. H. Zawati, Laura M. Beskow, Kathleen M. Brelsford, Kyle B. Brothers, Catherine M. Hammack-Aviran, James W. Hazel, Yann Joly, Michael Lang, Dimitri Patrinos, Andrea Saltzman & Bartha Maria Knoppers - 2019 - Journal of Law, Medicine and Ethics 47 (4):705-731.
  21. Protecting Participants in Genomic Research: Understanding the “Web of Protections” Afforded by Federal and State Law.Leslie E. Wolf, Catherine M. Hammack, Erin Fuse Brown, Kathleen M. Brelsford & Laura M. Beskow - 2020 - Journal of Law, Medicine and Ethics 48 (1):126-141.
    Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.
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