8 found
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Barbara E. Bierer [6]Barbara Bierer [2]
  1.  15
    Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule.Holly Fernandez Lynch, Barbara E. Bierer & I. Glenn Cohen - 2016 - Hastings Center Report 46 (1):4-5.
    On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...)
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  2.  4
    The Decision to Enroll in a Clinical Trial Should Be Unencumbered.Luke Gelinas & Barbara E. Bierer - 2020 - American Journal of Bioethics 20 (9):23-25.
    Volume 20, Issue 9, September 2020, Page 23-25.
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  3.  6
    Incorporating Ethical Principles Into Clinical Research Protocols: A Tool for Protocol Writers and Ethics Committees.Rebecca H. Li, Mary C. Wacholtz, Mark Barnes, Liam Boggs, Susan Callery-D'Amico, Amy Davis, Alla Digilova, David Forster, Kate Heffernan, Maeve Luthin, Holly Fernandez Lynch, Lindsay McNair, Jennifer E. Miller, Jacquelyn Murphy, Luann Van Campen, Mark Wilenzick, Delia Wolf, Cris Woolston, Carmen Aldinger & Barbara E. Bierer - 2016 - Journal of Medical Ethics 42 (4):229-234.
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  4.  6
    Research Misconduct Involving Noncompliance in Human Subjects Research Supported by the Public Health Service:Reconciling Separate Regulatory Systems.Barbara E. Bierer & Mark Barnes - 2014 - Hastings Center Report 44 (s3):S2-S26.
  5.  3
    Research Subject Injury Compensation: The Ongoing Search for Fairness, Consistency and Clarity.Mark Barnes, Jamie Flaherty & Barbara E. Bierer - 2019 - Journal of Law, Medicine and Ethics 47 (4):748-750.
  6. MRCT Center Post-Trial Responsibilities Framework Continued Access to Investigational Medicines. Guidance Document. Version 1.0, December 2016.Carmen Aldinger, Barbara Bierer, Rebecca Li, Luann Van Campen, Mark Barnes, Eileen Bedell, Amanda Brown-Inz, Robin Gibbs, Deborah Henderson, Christopher Kabacinski, Laurie Letvak, Susan Manoff, Ignacio Mastroleo, Ellie Okada, Usharani Pingali, Wasana Prasitsuebsai, Hans Spiegel, Daniel Wang, Susan Briggs Watson & Marc Wilenzik - 2016 - The Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center).
    I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (...)
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  7.  20
    Institutions as an Ethical Locus of Research Prioritisation.Luke Gelinas, Holly Fernandez Lynch, Barbara Bierer & I. Glenn Cohen - 2017 - Journal of Medical Ethics 43 (12):816-818.
    Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in (...)
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  8.  12
    Social Media as an Ethical Tool for Retention in Clinical Trials.Luke Gelinas & Barbara E. Bierer - 2019 - American Journal of Bioethics 19 (6):62-64.
    Volume 19, Issue 6, June 2019, Page 62-64.
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