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
Disparate data retention standards in biomedical research.
Authors: Authors: Lye CT, Caron MM, Walsh L, Bierer BE, Barnes M.
Account Res
View full abstract on Pubmed
Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.
Authors: Authors: Glazier A, DeCormier Plosky W, Bierer BE.
NEJM Evid
View full abstract on Pubmed
Ethical, Legal, and Social Issues (ELSI) in Human Somatic Gene Therapy Clinical Research: A Scoping Review.
Authors: Authors: Chapman CR, Shaikh M, Glazier A, Creamer A, Bierer BE.
Hum Gene Ther
View full abstract on Pubmed
Characteristics of long-term follow-up studies for gene therapies registered on ClinicalTrials.gov.
Authors: Authors: Chapman CR, Glazier A, Berbic E, Bierer BE.
Gene Ther
View full abstract on Pubmed
A scoping review of challenges in pediatric health technology assessments with a focus on pharmaceutical interventions.
Authors: Authors: Hutchinson N, Otterman LS, Bain PA, Koppelman E, Bierer BE.
Int J Technol Assess Health Care
View full abstract on Pubmed
Practice of data sharing plans in clinical trial registrations and concordance between registered and published data sharing plans: a cross-sectional study.
Authors: Authors: Zhang J, Bierer BE, Van Spall HGC, Liu Y, Bai X, Thabane L, Lip GYH, Sun X, Moher D, Li G.
BMC Med
View full abstract on Pubmed
Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment.
Authors: Authors: Albert-Rozenberg D, Peloquin D, Liss J, Hanson E, Bierer BE.
J Law Med Ethics
View full abstract on Pubmed
Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions.
Authors: Authors: Barksdale EKS, Selig W, DeCormier Plosky W, Miller E, McDonough K, Backler C, George E, Fleury ME, Taylor MJ, Pankevich DE, Murphy J, Hermann K, Davis LA, DeCotiis G, Gonzalez-Cerimele C, Cook C, Shaw S, Gelinas L, Dornsife DL, Bierer BE, Gerber DE.
J Clin Oncol
View full abstract on Pubmed
An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity.
Authors: Authors: Nguyen E, Appiah D, Ne'eman A, Shi M, Bierer BE, DeCormier Plosky W, Resnik DB.
J Empir Res Hum Res Ethics
View full abstract on Pubmed
A global call to action for disability inclusion in health research.
Authors: Authors: Anderson AM, Martin RA, DeCormier Plosky W, Ned L, Swenor BK, Bailie J, Mathias K, Maggo JK, Omino MA, Russell AM, Lawson AMM, Brown AE, Bierer BE, Shariq S, Mwifadhi M, Deane KHO, Philip S, Shepherd V, Walsh NE, McHugh GA.
Nat Med
View full abstract on Pubmed