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
IRBs and the Protection-Inclusion Dilemma: Finding a Balance.
Authors: Authors: Friesen P, Gelinas L, Kirby A, Strauss DH, Bierer BE.
Am J Bioeth
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Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products.
Authors: Authors: Carmeli AB, Meloney L, Bierer BE.
Patterns (N Y)
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Data sharing in the context of community-engaged research partnerships.
Authors: Authors: Emmons KM, Mendez S, Lee RM, Erani D, Mascioli L, Abreu M, Adams S, Daly J, Bierer BE.
Soc Sci Med
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How to limit uninformative trials: Results from a Delphi working group.
Authors: Authors: Gelinas L, Hutchinson N, Zarin DA, Bierer BE.
Med
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Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials.
Authors: Authors: Hutchinson N, Gelinas L, Zarin D, Bierer BE.
JAMA
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Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials? Design and Feasibility of the Observational Patient Evidence for Regulatory Approval Science and Understanding Disease Project.
Authors: Authors: Crown W, Dahabreh IJ, Li X, Toh S, Bierer B.
Value Health
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Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions.
Authors: Authors: Green JM, Goodman P, Kirby A, Cobb N, Bierer BE.
J Clin Transl Sci
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Terms and conditions apply: an ethical analysis of mobile health user agreements in research.
Authors: Authors: Gelinas L, Morrell W, Bierer BE.
J Law Biosci
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Deprioritization of Ongoing Clinical Trials.
Authors: Authors: Bierer BE, Zarin DA, Gelinas L.
Ethics Hum Res
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Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.
Authors: Authors: Gelinas L, Morrell W, Tse T, Glazier A, Zarin DA, Bierer BE.
J Clin Transl Sci
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