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  1.  17
    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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  2.  5
    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.  7
    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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  4.  6
    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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    A Survey of Overlapping Surgery Policies at U.S. Hospitals.Margaret B. Mitchell, Catherine M. Hammack-Aviran, Ellen W. Clayton & Alexander Langerman - 2021 - Journal of Law, Medicine and Ethics 49 (1):64-73.
    The authors surveyed hospitals across the country on their policies regarding overlapping surgery, and found large variation between hospitals in how this practice is regulated. Specifically, institutions chose to define “critical portions” in a variety of ways, ultimately affecting not only surgical efficiency but also the autonomy of surgical trainees and patient experiences at these different hospitals.
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  6.  9
    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.