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
The Promise and Perils of Diversity Action Plans for Clinical Trials.
Authors: Authors: Varma T, Bierer BE, Hantel A.
JAMA
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Declaration of Helsinki-Revisions for the 21st Century.
Authors: Authors: Bierer BE.
JAMA
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The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research.
Authors: Authors: Bierer BE.
J Bone Joint Surg Am
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Acupuncture for hot flashes in hormone receptor-positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.
Authors: Authors: Lu W, Giobbie-Hurder A, Tanasijevic A, Kassis SB, Park SH, Jeong YJ, Shin IH, Yao C, Jung HJ, Zhu Z, Bao C, Bao T, Yang E, Bierer BE, Ligibel JA.
Cancer
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The PubPeer conundrum: Administrative challenges in research misconduct proceedings.
Authors: Authors: Caron MM, Lye CT, Bierer BE, Barnes M.
Account Res
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Proposed Increases in Government Authority Over Research Misconduct Proceedings.
Authors: Authors: Caron MM, Barnes M, Bierer BE.
JAMA
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The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff.
Authors: Authors: South A, Snowdon C, Burnett E, Bierer BE, Gillies K, Isaacs T, Sydes MR.
Trials
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First, do no harm: a global perspective on diversity and inclusion in clinical trials.
Authors: Authors: Wright K, DeCormier Plosky W, Ahmed HR, White SA, Bierer BE.
Nat Rev Drug Discov
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Returning Individual Research Results from Digital Phenotyping in Psychiatry.
Authors: Authors: Shen FX, Baum ML, Martinez-Martin N, Miner AS, Abraham M, Brownstein CA, Cortez N, Evans BJ, Germine LT, Glahn DC, Grady C, Holm IA, Hurley EA, Kimble S, Lázaro-Muñoz G, Leary K, Marks M, Monette PJ, Onnela JP, O'Rourke PP, Rauch SL, Shachar C, Sen S, Vahia I, Vassy JL, Baker JT, Bierer BE, Silverman BC.
Am J Bioeth
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Editorial: Building the clinical research workforce: challenges, capacities and competencies.
Authors: Authors: Jones CT, Johnson E, Bierer BE, Snyder DC, Smith HA, Akuffo E, Sonstein S.
Front Pharmacol
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