Holly Fernandez Lynch
  • Titles:
  • John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics and Health Policy
  • Assistant Faculty Director, MEHP Online Educational Initiatives
  • Assistant Professor of Law (secondary)
  • Senior Fellow, Leonard Davis Institute of Health Economics
  • Greenwall Faculty Scholar
  • Education:
  • JD, University of Pennsylvania School of Law
  • MBe, University of Pennsylvania, Bioethics
  • BA, University of Pennsylvania, Health and Societies/Bioethics

Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She co-chairs the PSOM Research Ethics and Policy Series (REPS) and serves as Assistant Faculty Director of Online Education in the Department, where she helps lead the Master of Health Care Innovation. She has a secondary appointment as an Assistant Professor of Law at the University of Pennsylvania Carey Law School. Professor Fernandez Lynch is committed to promoting racial and ethnic diversity in the field of bioethics and encourages inclusive sharing of opportunities. When seeking speakers, collaborators, and faculty candidates, please consider this list of diverse bioethicists (and suggest additions): http://bit.ly/DiverseBioethics

A lawyer and bioethicist by training, Professor Fernandez Lynch’s scholarly work focuses on clinical research ethics, access to investigational medicines outside clinical trials, Food and Drug Administration (FDA) policy, and the ethics of gatekeeping in health care. Her specific areas of expertise include Institutional Review Board (IRB) quality, payment to research participants, research prioritization, pre-approval access pathways (e.g., Expanded Access, Emergency Use Authorization, and Right to Try), human infection challenge studies, research risks to bystanders, research with biospecimens, the use of social media in research settings, and patient-engaged research. During the COVID-19 pandemic, Professor Fernandez Lynch published extensively on drug and vaccine development and authorization, ethical conduct of research, allocation of scarce investigational products, challenge studies, and political influence on FDA. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise, as well as co-editor of seven books, covering human subjects research regulationFDA regulation of drugs and new technologieshealth law and behavioral economicslaw, religion, and healthbiospecimen researchbig data, health law, and bioethics; and transparency in health care. Her courses at Penn include “Ethics, Regulation, and Politics of Science,” “Fundamentals of Health Law and Policy,” and “Bioethics and the Body.”

Professor Fernandez Lynch is the founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), a collaborative effort established in 2018 to understand, evaluate, and improve IRB quality and effectiveness. She served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019. She is currently a member of the Boards of Public Responsibility in Medicine & Research (PRIM&R) and the American Society for Law, Medicine, and Ethics (ASMLE), as well as a member of the NYU Working Group on Compassionate Use and Preapproval Access (CUPA). She is also an ethics consultant to the Robert Wood Johnson Foundation. She was named a Greenwall Faculty Scholar in 2019 and received the inaugural Baruch A. Brody Award in 2020.

Prior to joining Penn, Professor Fernandez Lynch was the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School (2012-2017) and Teaching Faculty in the Master of Bioethics program at Harvard Medical School. She worked as an attorney in private practice focused on pharmaceuticals regulation at Hogan & Hartson, LLP, as a bioethicist at the NIH’s Division of AIDS, and as a senior policy and research analyst with President Obama's Commission for the Study of Bioethical Issues. She has also served as an IRB member at the Fenway Institute in Boston. Professor Fernandez Lynch attended college at Penn, was a Levy Scholar in Law and Bioethics at Penn Law, and earned a Master of Bioethics also from Penn.

Complete List of Published Work: https://www.ncbi.nlm.nih.gov/myncbi/1VsirTDQjhT5x/bibliography/public/

Selected Publications

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