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
Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.
Authors: Authors: Gelinas L, Pierce R, Winkler S, Cohen IG, Lynch HF, Bierer BE.
Am J Bioeth
View full abstract on Pubmed
Forensic bitemark identification: weak foundations, exaggerated claims.
Authors: Authors: Saks MJ, Albright T, Bohan TL, Bierer BE, Bowers CM, Bush MA, Bush PJ, Casadevall A, Cole SA, Denton MB, Diamond SS, Dioso-Villa R, Epstein J, Faigman D, Faigman L, Fienberg SE, Garrett BL, Giannelli PC, Greely HT, Imwinkelried E, Jamieson A, Kafadar K, Kassirer JP, Koehler J', Korn D, Mnookin J, Morrison AB, Murphy E, Peerwani N, Peterson JL, Risinger DM, Sensabaugh GF, Spiegelman C, Stern H, Thompson WC, Wayman JL, Zabell S, Zumwalt RE.
J Law Biosci
View full abstract on Pubmed
Confronting Biospecimen Exceptionalism in Proposed Revisions to the Common Rule.
Authors: Authors: Lynch HF, Bierer BE, Cohen IG.
Hastings Cent Rep
View full abstract on Pubmed
Responsibilities of Data Monitoring Committees: Consensus Recommendations.
Authors: Authors: Bierer BE, Li R, Seltzer J, Sleeper LA, Frank E, Knirsch C, Aldinger CE, Levine RJ, Massaro J, Shah A, Barnes M, Snapinn S, Wittes J.
Ther Innov Regul Sci
View full abstract on Pubmed
A Global, Neutral Platform for Sharing Trial Data.
Authors: Authors: Bierer BE, Li R, Barnes M, Sim I.
N Engl J Med
View full abstract on Pubmed
Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees.
Authors: Authors: Li RH, Wacholtz MC, Barnes M, Boggs L, Callery-D'Amico S, Davis A, Digilova A, Forster D, Heffernan K, Luthin M, Lynch HF, McNair L, Miller JE, Murphy J, Van Campen L, Wilenzick M, Wolf D, Woolston C, Aldinger C, Bierer BE.
J Med Ethics
View full abstract on Pubmed
Standards for Clinical Research: Keeping Pace With the Technology of the Future.
Authors: Authors: Antman EM, Bierer BE.
Circulation
View full abstract on Pubmed
The Education Review Board: A Mechanism for Managing Potential Conflicts of Interest in Medical Education.
Authors: Authors: Borus JF, Alexander EK, Bierer BE, Bringhurst FR, Clark C, Klanica KE, Stewart EC, Friedman LS.
Acad Med
View full abstract on Pubmed
Compliance with results reporting at ClinicalTrials.gov.
Authors: Authors: Hallinan ZP, Getz KA, Bierer BE.
N Engl J Med
View full abstract on Pubmed
The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.
Authors: Authors: Winkler SJ, Witte E, Bierer BE.
Clin Transl Sci
View full abstract on Pubmed