Holly Fernandez Lynch, JD, MBe

When seeking speakers, collaborators, and faculty candidates, please consider this list of diverse bioethicists (and suggest additions): www.diversebioethics.org

Holly Fernandez Lynch (she/her) is Associate Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine (PSOM), University of Pennsylvania. She has a secondary appointment as Associate Professor of Law at the University of Pennsylvania Carey Law School.

A lawyer and bioethicist by training, Professor Fernandez Lynch is an expert on the ethics of gatekeeping in health care. Her primary areas of empirical and conceptual scholarship and policy work are FDA oversight of medical products and Institutional Review Board (IRB) oversight of research. In particular, she studies regulatory flexibility for diseases with unmet needs, rare disease drug development and advocacy, individualized therapies, and psychedelic science and policy, as well as pre-approval access mechanisms (e.g., Expanded Access, Emergency Use Authorization, and Right to Try). On the side of research ethics, she primarily studies IRB quality, payment to research participants, and research prioritization. Professor Fernandez Lynch is co-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. 

Professor Fernandez Lynch was named a Greenwall Faculty Scholar from 2019-2022 and a National Academy of Medicine Emerging Leader in Health and Medicine from 2022-2025. She received the inaugural Baruch A. Brody Award in 2020, was elected a Hastings Center Fellow in 2021, was named to the STAT News “STATus List” in 2025, and in 2026 won the Greenwall Foundation's Bernie Lo, MD Award in Bioethics for Bridging Division Through Bioethics.

Professor Fernandez Lynch has served as a member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP). She also served as Board President of the American Society for Law, Medicine, and Ethics (ASMLE) and board member of Public Responsibility in Medicine & Research (PRIM&R). She was “Ethicist in Residence” at the Robert Wood Johnson Foundation and continues to serve as their ethics consultant. She currently serves on the Hastings Center Fellows Council and as a member of the NYU Working Group on Compassionate Use and Preapproval Access (CUPA). 

Professor Fernandez Lynch’s research has been funded by the Greenwall Foundation, Arnold Ventures, the National Institutes of Health, and ARPA-H, among others. Her scholarship is frequently published in leading clinical, bioethics, and policy journals, as well as popular media outlets. She is the author of Conflicts of Conscience in Health Care: An Institutional Compromise (2008), as well as co-editor of seven books, covering human subjects research regulation; FDA regulation of drugs and new technologies; health law and behavioral economics; law, religion, and health; biospecimen research; big data, health law, and bioethics; and transparency in health care. She has served on National Academies committees focused on accelerating treatments and improving quality of life for people living with ALS and strategies to align investment in innovation with unmet needs.

Professor Fernandez Lynch’s courses at Penn include "FDA Law and Policy" (offered Spring 2027), “Research Ethics," “Bioethics and Law,” “Ethics, Regulation, and Politics of Science,” “Fundamentals of Health Law and Policy,” and “Bioethics and the Body.”

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 (’03), was a Levy Scholar in Law and Bioethics at Penn Law (’06), and earned a Master of Bioethics (’06) also from Penn.