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
Aggregating data from COVID-19 trials.
Authors: Authors: Ogburn EL, Bierer BE, Brookmeyer R, Choirat C, Dean NE, De Gruttola V, Ellenberg SS, Halloran ME, Hanley DF, Lee JK, Wang R, Scharfstein DO.
Science
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Economic vulnerability and payment for research participation.
Authors: Authors: Gelinas L, White SA, Bierer BE.
Clin Trials
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Disruptive and avoidable: GDPR challenges to secondary research uses of data.
Authors: Authors: Peloquin D, DiMaio M, Bierer B, Barnes M.
Eur J Hum Genet
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Issues in the registration of database studies.
Authors: Authors: Zarin DA, Crown WH, Bierer BE.
J Clin Epidemiol
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Facilitating collaborative animal research: The development and implementation of a Master Reciprocal Institutional Agreement for Animal Care and Use.
Authors: Authors: Holthaus K, Goldberg D, Connelly C, Corning B, Nascimento C, Witte E, Bierer BE.
J Clin Transl Sci
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Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement.
Authors: Authors: Caruso R, Myatt T, Bierer BE.
J Clin Transl Sci
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Time for NIH to lead on data sharing.
Authors: Authors: Sim I, Stebbins M, Bierer BE, Butte AJ, Drazen J, Dzau V, Hernandez AF, Krumholz HM, Lo B, Munos B, Perakslis E, Rockhold F, Ross JS, Terry SF, Yamamoto KR, Zarin DA, Li R.
Science
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Leveling the Joint Task Force Core Competencies for Clinical Research Professionals.
Authors: Authors: Sonstein SA, Namenek Brouwer RJ, Gluck W, Robert Kolb H, Aldinger C, Bierer BE, Thomas Jones C.
Ther Innov Regul Sci
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Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov.
Authors: Authors: Statham EE, White SA, Sonwane B, Bierer BE.
PLoS One
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Research Subject Injury Compensation: The Ongoing Search for Fairness, Consistency and Clarity.
Authors: Authors: Barnes M, Flaherty J, Bierer BE.
J Law Med Ethics
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