|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Knowledge & Support Program|
Toolkits, guidance, templates, and FAQs to help researchers achieve and maintain regulatory compliance.
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.
In particular, the program:
The goal is not to create a new, centralized, single system for regulatory review of clinical & translational (C/T) research at Harvard, but to incorporate each participating entity's best qualities and processes into a comprehensive, cooperative, and integrated system.
The program provides integrated, coordinated, comprehensive 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 efforts, the Regulatory Knowledge and Support Program has convened the Regulatory Committee comprised of institutional officials, compliance officers, and directors of human research protections from the Harvard Catalyst-participating institutions as well as ex officio members from the Harvard University Provost's Office and Harvard Medical School's Office for Professional Standards and Integrity. The committee serves as the effector arm for a broad array of initiatives and support processes, including issues related to IRBs, HRPPs, research subject advocacy, privacy and data-sharing, education and training, and compliance with regulatory requirements. The Regulatory Committee meets monthly and most decisions are made by consensus. The Committee is responsible for development, approval, and implementation of streamlined processes and, where possible, policies, across Harvard and Harvard-affiliated institutions. Committee members spearhead the implementation of the Committee's recommendations at their home institutions and identify local problems with implementation that require further analysis and solutions.
The program has also convened subcommittees, task forces, and working groups to explore and make recommendations concerning issues that pose special challenges, risks, or opportunities for Harvard Catalyst and its participating institutions. These subcommittees develop aligned policies and procedures, guidance documents, templates, and toolkits covering a diverse set of regulatory topic areas, including: Clinical Research Management, Community Engaged Research, Data Security and Privacy, Regulatory Education, INDs and IDEs, International Research, and Continuous Quality Improvement.
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.