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
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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Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India.
Authors: Authors: Balsari S, Fortenko A, Blaya JA, Gropper A, Jayaram M, Matthan R, Sahasranam R, Shankar M, Sarbadhikari SN, Bierer BE, Mandl KD, Mehendale S, Khanna T.
J Med Internet Res
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Truth in Advertising: Disclosure of Participant Payment in Research Recruitment Materials.
Authors: Authors: Gelinas L, Lynch HF, Largent EA, Shachar C, Cohen IG, Bierer BE.
Ther Innov Regul Sci
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On Scarcity and the Value of Clinical Trials.
Authors: Authors: Gelinas L, Lynch HF, Bierer BE, Cohen IG.
Am J Bioeth
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A Framework for Ethical Payment to Research Participants.
Authors: Authors: Gelinas L, Largent EA, Cohen IG, Kornetsky S, Bierer BE, Fernandez Lynch H.
N Engl J Med
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Development of a plain-language library of educational resources for research participants.
Authors: Authors: Witte E, Winkler SJ, Myerson J, Kirby A, Biggers J, Do JM, Roth MT, Gateman AK, Cagliero E, Bierer BE.
J Clin Transl Sci
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Sharing and reuse of individual participant data from clinical trials: principles and recommendations.
Authors: Authors: Ohmann C, Banzi R, Canham S, Battaglia S, Matei M, Ariyo C, Becnel L, Bierer B, Bowers S, Clivio L, Dias M, Druml C, Faure H, Fenner M, Galvez J, Ghersi D, Gluud C, Groves T, Houston P, Karam G, Kalra D, Knowles RL, Krleža-Jeric K, Kubiak C, Kuchinke W, Kush R, Lukkarinen A, Marques PS, Newbigging A, O'Callaghan J, Ravaud P, Schlünder I, Shanahan D, Sitter H, Spalding D, Tudur-Smith C, van Reusel P, van Veen EB, Visser GR, Wilson J, Demotes-Mainard J.
BMJ Open
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Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule.
Authors: Authors: Lynch HF, Cohen IG, Bierer BE.
IRB
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The Revised and Final Common Rule: An Unfinished Story.
Authors: Authors: Bierer BE.
IRB
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