Barbara E Bierer

Barbara Emily Bierer, MD

Professor of Medicine (Pediatrics), HMS
Member, HMS Center for Bioethics

Barbara Bierer, MD is a Professor of Medicine (Pediatrics) at Harvard Medical School (HMS), and a hematologist/oncologist at the Brigham and Women's Hospital (BWH). She received her MD from HMS. She is the director of the Regulatory Foundations, Law and Ethics Program of the Harvard Catalyst, the Harvard Clinical and Translational Science Award, and the director of regulatory policy, SMART IRB. Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center), a University-wide and collaborative effort to improve the ethics, conduct, and regulatory environment for multi-site, multi-national clinical trials. She is a co-founder of COVID-19 Collaboration Platform, a platform for cooperation in research. In 2017, the MRCT Center launched the non-profit Vivli, a global clinical research data sharing platform. From 2003-2014, she served as Senior Vice President, Research, at BWH and was the institutional official for human subjects and animal research, for biosafety and for research integrity at the BWH. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. Dr. Bierer established and directed the Center for Faculty Development and Diversity at the BWH; for these efforts, she was the first recipient of the HMS Harold Amos Faculty Diversity Award.

Publications View
Responsibilities of Data Monitoring Committees: Consensus Recommendations.
Authors: Authors: Bierer BE, Li R, Seltzer J, Sleeper LA, Frank E, Knirsch C, Aldinger CE, Levine RJ, Massaro J, Shah A, Barnes M, Snapinn S, Wittes J.
Ther Innov Regul Sci
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A Global, Neutral Platform for Sharing Trial Data.
Authors: Authors: Bierer BE, Li R, Barnes M, Sim I.
N Engl J Med
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Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.
Authors: Authors: Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D'Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M, Lynch HF, McNair L, Miller JE, Murphy J, Van Campen L, Wilenzick M, Wolf D, Woolston C, Aldinger C, Bierer BE.
J Med Ethics
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Standards for Clinical Research: Keeping Pace With the Technology of the Future.
Authors: Authors: Antman EM, Bierer BE.
Circulation
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The Education Review Board: A Mechanism for Managing Potential Conflicts of Interest in Medical Education.
Authors: Authors: Borus JF, Alexander EK, Bierer BE, Bringhurst FR, Clark C, Klanica KE, Stewart EC, Friedman LS.
Acad Med
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Compliance with results reporting at ClinicalTrials.gov.
Authors: Authors: Hallinan ZP, Getz KA, Bierer BE.
N Engl J Med
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The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.
Authors: Authors: Winkler SJ, Witte E, Bierer BE.
Clin Transl Sci
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Research misconduct involving noncompliance in human subjects research supported by the public health service: reconciling separate regulatory systems.
Authors: Authors: Bierer BE, Barnes M.
Hastings Cent Rep
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A distributed model: redefining a robust research subject advocacy program at the Harvard Clinical and Translational Science Center.
Authors: Authors: Winkler SJ, Cagliero E, Witte E, Bierer BE.
Clin Transl Sci
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Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: providing an IND/IDE consult service in a decentralized network of academic healthcare centers.
Authors: Authors: Kim MJ, Winkler SJ, Bierer BE, Wolf D.
Clin Transl Sci
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