As investigators sort the regulatory issues inherent in the research process, many questions typically arise: How do I apply for an IRB exemption? What do I need to know about MTAs? What if I’m using an investigative drug? Since 2008, Harvard Catalyst | The Harvard Clinical and Translational Research Center has offered free resources to assist researchers in navigating the regulatory maze.
One of the resources, the Regulatory Knowledge & Support Program helps minimize regulatory burdens by promoting cooperation among institutions, advising researchers on best practices related to human subjects’ protections, research involving laboratory animals, patient privacy, quality improvement, contracting and support for FDA-and non-FDA-regulated research. The goal of the program has been to incorporate each participating entity's best processes into a comprehensive, cooperative and integrated system that manages the regulatory process of clinical and translational research. The Regulatory Atlas also provides information about resources, forms, policies and contacts at Harvard Catalyst’s participating institutions.
For more information, click on the video link above.
