Bruce Jennings has joined the research team of a two-year project launched by the Georgetown University Law Center and funded by The Greenwall Foundation
“Establishing Ethical Standards for Evidence-Based Tobacco Control to Safeguard the Public’s Health Under Federal, State, and Local Law.” The U.S. Tobacco Control Act generally empowers FDA to act within its authorities to reduce tobacco use harms whenever FDA determines, without being “arbitrary or capricious,” that the action is “appropriate for the protection of the public health.” But these statutory standards have not yet been fully defined or clarified. This project will use bioethical principles and analyses to develop those legally viable interpretations that would operate most effectively and ethically to promote the public health – and then show how the clarified standards apply to FDA’s pre-market review of new tobacco products and possible future rulemaking. This ethical analysis will facilitate more rapid and constructive FDA action to reduce tobacco’s toll by providing a clearer, more complete framework to guide stakeholders, FDA staff, government officials who clear proposed FDA actions, and researchers, and by helping ensure that future court rulings on the Tobacco Act’s standards consider their ethical dimensions.
For additional information see: http://www.law.georgetown.edu/oneillinstitute/news/TobaccoControlActtoHelpFDAandtheCourts.cfm
Bruce Jennings will serve as a project consultant for a five-year collaborative project between Yale University and Central South University, Changsha, China, funded by The Fogarty International Center
“International Research Ethics Education and Curriculum Development Program.” The project will develop a sustainable, innovative and interdisciplinary Master of Bioethics, develop an integrated Human Research Protection Program (HRPP), and establish a Bioethics Training Institute at Central South University. The MBE program will provide a cadre of Chinese health-focused policy makers, practitioners and researchers with the skills to respond to contemporary bioethics challenges encountered in their field. Graduates of this program will become bioethics thought leaders and resources for others seeking consultations in their institutions. The HRPP will integrate the two newly established IRBs at the Xiangya Schools of Nursing and Public Health with the longer established IRBs at the Xiangya School of Medicine and its three affiliated hospitals and develop a formal process to monitor, evaluate and continually improve the protection of participants in research.