Penn Bioethics Seminar | Holly Fernandez Lynch, JD, MBE

Thinking About Bystanders to Research

Research ethics and regulation have largely focused on protecting research participants, the individuals who are directly intervened upon or interacted with for research purposes. But some studies may also expose bystanders to the risk of harm. For example, gene therapy research might harm a participant’s offspring, antibiotic research might contribute to resistance that can affect communities, and HIV cure studies that require cessation of antiretrovirals pose risks to participants’ sex partners and others. Challenge trials in which research participants are intentionally exposed to infectious pathogens also pose important risks to bystanders. In this talk, I will discuss two issues relevant to research bystanders, with a focus on the challenge trial context: (1) How much research risk can bystanders appropriately be exposed to, and (2) Should study participants be allowed to exercise their right to withdraw from research when doing so would expose bystanders to the risk of harm.

Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in theDepartment of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania. Her work focuses on the ethics and regulation of human subjects research and related areas. She founded the Consortium to Advance Effective Research Ethics Oversight (AEREO) in 2018, a collaboration of academics and Human Research Protection Program directors seeking to empirically evaluate and improve the effectiveness of research ethics review and oversight. She served as an appointed member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019.