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
A Federally Qualified Health Center-led Ethics & Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs During COVID-19.
Authors: Authors: Torres CH, Kassis SB, Sayeed S, Bierer BE, Emmons KM.
J Law Med Ethics
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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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Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency.
Authors: Authors: Sonstein SA, Silva H, Jones CT, Bierer BE.
Front Pharmacol
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Engaging children and adolescents in the design and conduct of paediatric research.
Authors: Authors: Bierer BE, Koppelman E, Croker AK, Hosseinzadeh S, Hovinga C, Joffe S, McMillan G, Nelson R, Bucci-Rechtweg C.
Front Pediatr
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Ethical Considerations in Decentralized Clinical Trials.
Authors: Authors: Bierer BE, White SA.
J Bioeth Inq
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Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial.
Authors: Authors: South A, Bailey J, Bierer BE, Burnett E, Cragg WJ, Diaz-Montana C, Gillies K, Isaacs T, Joharatnam-Hogan N, Snowdon C, Sydes MR, Copas AJ.
Clin Trials
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Defining "recklessness" in research misconduct proceedings.
Authors: Authors: Caron MM, Dohan SB, Barnes M, Bierer BE.
Account Res
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Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection-Inclusion Dilemma.
Authors: Authors: Friesen P, Gelinas L, Kirby A, Strauss DH, Bierer BE.
Am J Bioeth
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Review of diversity, equity, and inclusion by ethics committees: A Delphi consensus statement.
Authors: Authors: Meloney LG, Ahmed H, Bierer BE.
Med
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Establishing a global regulatory floor for children's decisions about participation in clinical research.
Authors: Authors: Joffe S, Allen AJ, Davis JM, Koppelman E, Kornetsky SZ, Ku GMV, Miller VA, Preston J, Shah LD, Bierer BE.
Pediatr Res
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