September Research Ethics Consortium 

Ethical Challenges of Phase 1 Clinical Trials

Research that involves phase I clinical trials raise particular ethical challenges, especially trials that involve novel therapies being tested in humans for the first time. This month, we will discuss ethical challenges around a phase 1 clinical trial in Rennes, France that resulted in the death of one person and the hospitalization of five others.

Presenters: 
Spencer Hey, PhD
Co-Director, Research Ethics, Harvard Center for Bioethics 
Research Fellow, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital

Joseph Cravero, MD
Senior Associate, Perioperative Anesthesia and Pain Medicine
Associate Professor of Anaesthesia, Harvard Medical School

Commentator:
Barbara Bierer, MD
Faculty Director, Multi-Regional Clinical Trials Center, Harvard University
Professor of Medicine, Harvard Medical School

Moderator: 
Bizu Gelaye, PhD
Co-Director, Research Ethics, Harvard Center for Bioethics
Assistant Professor, Division of Global Psychiatry, Massachusetts General Hospital

The Research Ethics Consortium is a multi-disciplinary forum for members of institutional review boards and research ethics committees at Harvard and its affiliated teaching hospitals, as well as Harvard University clinical researchers, students, fellows and faculty. Lunch provided. Registration is required.