Assistant Professor of Medical Ethics, Perelman School of Medicine
Assistant Professor of Law (secondary), Carey Law School University of Pennsylvania
University of Pennsylvania Perelman School of Medicine
About
Scholar Project
Holly Fernandez Lynch, JD, MBE, is Associate Professor of Medical Ethics and Law at the University of Pennsylvania. Her research focuses on FDA pharmaceutical and biotechnology policy, especially approaches to drug development and early approval pathways for diseases with unmet treatment needs. She also studies access to investigational medicines, clinical research ethics and regulation, and psychedelic science and policy. She is founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight, a collaborative endeavor to improve IRB quality. She is an emeritus board member of Public Responsibility in Medicine & Research (PRIM&R) and immediate past president of the board of the American Society for Law, Medicine, and Ethics. She has served as a member of the Secretary’s Advisory Committee on Human Research Protection (SACHRP), as the ethicist in residence at the Robert Wood Johnson Foundation, and as a member of National Academies committees focused on accelerating treatments for ALS and improving investment in innovation to address unmet medical needs. Professor Fernandez Lynchhas previously worked as an attorney in private practice, a bioethicist serving NIH’s Division of AIDS, an analyst with President Obama's Commission for the Study of Bioethical Issues, and executive director of Harvard Law School's bioethics and health law research program. She earned graduate degrees in law and bioethics at the University of Pennsylvania.
Patients may exercise their autonomy only to the extent authorized by health care “gatekeepers,” including the government, insurers, clinicians, and industry. Motivated by calls to acknowledge patient expertise, as well as broader attacks on traditional expertise and authority, Professor Lynch’s project aims to generate an ethical framework to interrogate the scope, value, and legitimacy of health care gatekeeping and to develop sound policy approaches, with an emphasis on gatekeeping at the end of life.
Holly Fernandez Lynch, Elisa A. Hurley, & Holly A. Taylor, Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness, JAMA, Jun 2023
Holly Fernandez Lynch, Sandra Morris, and Jinsy A Andrews, Access to investigational drugs for patients with amyotrophic lateral sclerosis in the USA, The Lancet Neurology, Jul 2022.
Holly Fernandez Lynch & Holly A. Taylor, How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs?, AJOB Empirical Bioethics, Jun 2022.
Holly Fernandez Lynch, Whitney Eriksen, and Justin T. Clapp, “We measure what we can measure”: Struggles in defining and evaluating institutional review board quality, Social Science & Medicine, Jan 2022.
Holly Fernandez Lynch et al, Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research, Annals of Internal Medicine, Feb 2021.
Holly Fernandez Lynch et al, Prescription Requirements and Patient Autonomy: Considering an Over-the-Counter Default, The Hastings Center Report, Dec 2020.
Holly Fernandez Lynch et al, Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research, Annals of Internal Medicine, Oct 2020.
Jamie Webb et al, Ethically Allocating COVID-19 Drugs Via Pre-approval Access and Emergency Use Authorization, American Journal of Bioethics, Aug 2020.
Holly Fernandez Lynch et al, Facilitating Both Evidence and Access: Improving FDA's Accelerated Approval and Expanded Access Pathways, Journal of Law, Medicine & Ethics, Jul 2020.
