|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.)
Watch this video to find answers.
To learn more about the Ethics and Law Initiative please visit The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.
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.