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Barbara Emily Bierer, MD
Senior Physician, Brigham and Women's Hospital
Professor of Medicine (Pediatrics), Harvard Medical School

Brigham and Women's Hospital
Department of Medicine
75 Francis Street
Boston, MA 02115

Research Location: Peter Bent Brigham

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Research Narrative:


She is the Program Director of the Regulatory Foundations, Law and Ethics Program of the Harvard Catalyst, the Harvard Clinical and Translational Science Award. Dr. Bierer co-founded and now leads, as faculty co-director, the Multi-Regional Clinical Trials (MRCT) Center at Harvard, a University-wide and collaborative effort to improve standards for the planning and conduct of clinical trials in the developing world.  From 2003-2014, she served as Senior Vice President, Research, at the 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. In addition, she was the Co-Chair of the Partners HealthCare Committee on Conflict of Interest.  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 in 2008. 

In addition to her academic responsibilities, Dr. Bierer served on the Board of Directors of both the Association for Accreditation of Human Research Protection Programs (AAHRPP) and the Federation of American Societies for Experimental Biology (FASEB). She served as the Chair of the Secretary’s Advisory Committee for Human Research Protections, Department of Health and Human Services from 2008-2012.  She is currently a member of the National Academies of Sciences Committee on Science, Technology and the Law.  She serves on the Board of Directors of Public Responsibility in Medicine and Research (PRIM&R), dedicated to promoting the ethical conduct of biomedical and behavioral research; Management Sciences for Health (MSH), an international organization working in partnership globally to strengthen health care, local capability, and access; and the Edward P Evans Foundation, a foundation supporting biomedical research.  She has authored or co-authored over 200 publications and is on the editorial boards of a number of journals including Current Protocols of Immunology. 

Dr. Bierer received a B.S. from Yale University and an M.D. from Harvard Medical School.


Harvard Medical School, 1980, MD

Publications (Pulled from Harvard Catalyst Profiles):

1. Gelinas L, Crawford B, Kelman A, Bierer BE. Relocation of study participants for rare and ultra-rare disease trials: Ethics and operations. Contemp Clin Trials. 2019 Jul 19; 84:105812.

2. Davis JM, Yao L, Bierer BE. Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research. JAMA. 2019 Jul 12.

3. Gelinas L, Bierer BE. Social Media as an Ethical Tool for Retention in Clinical Trials. Am J Bioeth. 2019 06; 19(6):62-64.

4. Pierce HH, Dev A, Statham E, Bierer BE. Credit data generators for data reuse. Nature. 2019 06; 570(7759):30-32.

5. Bierer BE, Gelinas L. Scientific Merit Predicates Ethical Review of Clinical Research. Ethics Hum Res. 2019 May; 41(3):29-32.

6. Vardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N. Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance. Clin Trials. 2019 Jun; 16(3):290-296.

7. Bierer BE, Strauss DH, White SA, Zarin DA. Universal Funder Responsibilities That Advance Social Value. Am J Bioeth. 2018 Nov; 18(11):30-32.

8. Sonstein SA, Namenek Brower RJ, Gluck W, Kolb HR, Aldinger C, Bierer BE, Jones CT. Leveling the Joint Task Force Core Competencies for Clinical Research Professionals. Ther Innov Regul Sci. 2018 Oct 18; 2168479018799291.

9. 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. Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India. J Med Internet Res. 2018 07 13; 20(7):e10725.

10. Murray PD, Bierer BE, Hirschfeld S, Klein AK, Davis JM. Assessment of a shortened informed consent form for pediatric research: a pilot study. Pediatr Res. 2018 10; 84(4):516-519.