|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Knowledge & Support Program|
The Regulatory Knowledge and Support 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.
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 Knowledge & Support Program was recognized as a Best Practice in Human Research.