Barbara E Bierer
Barbara Emily Bierer, MD
Professor of Medicine (Pediatrics), HMS

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
Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations.
Authors: Authors: Gelinas L, Crawford B, Kelman A, Bierer BE.
Contemp Clin Trials
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Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research.
Authors: Authors: Davis JM, Yao L, Bierer BE.
JAMA
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Social Media as an Ethical Tool for Retention in Clinical Trials.
Authors: Authors: Gelinas L, Bierer BE.
Am J Bioeth
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Credit data generators for data reuse.
Authors: Authors: Pierce HH, Dev A, Statham E, Bierer BE.
Nature
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Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance.
Authors: Authors: Vardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N.
Clin Trials
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Scientific Merit Predicates Ethical Review of Clinical Research.
Authors: Authors: Bierer BE, Gelinas L.
Ethics Hum Res
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Returning aggregate results of clinical trials: Empirical data of patient preferences.
Authors: Authors: Aldinger CE, Ligibel J, Shin IH, Denninger JW, Bierer BE.
J Clin Transl Sci
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Universal Funder Responsibilities That Advance Social Value.
Authors: Authors: Bierer BE, Strauss DH, White SA, Zarin DA.
Am J Bioeth
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Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.
Authors: Authors: Sonstein SA, Namenek Brower RJ, Gluck W, Kolb HR, Aldinger C, Bierer BE, Jones CT.
Ther Innov Regul Sci
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Assessment of a shortened informed consent form for pediatric research: a pilot study.
Authors: Authors: Murray PD, Bierer BE, Hirschfeld S, Klein AK, Davis JM.
Pediatr Res
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