Biography
- Director, Research Ethics, Ann & Robert H. Lurie Children's Hospital of Chicago
- Founder's Board Chair of Medical Ethics, Ann & Robert H. Lurie Children's Hospital of Chicago
- Professor of Pediatrics (Advanced General Pediatrics and Primary Care), Northwestern University Feinberg School of Medicine
Seema K. Shah, JD, HEC-C, focuses on the question of when it is ethically and legally acceptable to expose some people to risk to benefit others. Her research has analyzed this question in pediatric, infectious disease, and global health research, as well as in the determination of death. Professor Shah is the Director of the Pediatric Research Ethics and Policy (PREP) Program and the Director of Research Ethics at Ann & Robert H. Lurie Children’s Hospital of Chicago. She is an Associate Professor of Pediatrics at Lurie Children’s and Northwestern University Feinberg School of Medicine, and holds a courtesy appointment at Northwestern University Pritzker School of Law.
Education and Background
- JD, Stanford Law School 2002-2005
- Bioethics Fellowship, Department of Clinical Bioethics, National Institutes of Health Clinical Center 2000-2002
- AB, Human Biology, Honors in Ethics & Society, Stanford University 1996-2000
Research Highlights
ETHICS IN THE INTERIM: LEARNING FROM THE COVID-19 PANDEMIC TO DEVELOP ETHICAL GUIDANCE FOR DATA AND SAFETY MONITORING COMMITTEES OVERSEEING CLINICAL TRIALS
The COVID-19 pandemic has revealed major gaps in research oversight, particularly regarding data and safety monitoring boards (DSMBs). DSMBs dynamically integrate uncertain information to determine whether to prematurely stop or otherwise modify trials. This makes DSMB ethics conceptually interesting as well as operationally challenging. Taking a mixed-methods approach, this project proposes to develop a pragmatic ethical framework and model charter to explicitly address the ethical considerations embedded in DSMB determinations, including in contexts of rapidly evolving evidence and policy.
