|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
The Regulatory Foundations, Ethics, and Law Program minimizes the regulatory burdens for investigators and promotes cooperation and interoperability by coordinating the diverse processes of inter-institutional research, including human subjects protections, patient privacy, quality improvement, contracting, and support for FDA-regulated research.
Specifically, the program:
The goal is not to create a new, centralized, single system for regulatory review of clinical and translational (C/T) research at Harvard University, but to incorporate each participating entity's best qualities and processes into a comprehensive, cooperative, and integrated system.
The program provides resources and services to the C/T research community, ensuring that all research is conducted with the highest standards of scientific design and guaranteeing participant safety, a high level of research ethics and integrity, and compliance with regulatory requirements.
In support of these aims, the program has launched a visitation program for local IRB members to observe the deliberations of another IRB. This program is intended to help identify best practices and innovative processes in the review of clinical and translational research. (Request schedule and more information.)
The Ethics and Law Initiative aims to develop innovative, practical solutions to stubborn and complex ethical and legal quandaries that hinder clinical and translational research. For more information, please visit The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics or contact us.
Boston Marathon bombing victims participate in a three-year hearing study, thanks to the Harvard Catalyst IRB Ceded Review Request System.
Learn why the work on the Reliance Agreement by Harvard Catalyst's Regulatory Foundations, Ethics, and Law Program was recognized as a Best Practice in Human Research.