Regulatory Knowledge and Support

The Regulatory Knowledge and Support Core was designed to encourage institutional collaborations that promote the protection of human subjects, including vulnerable populations. Through the ethical and compliant conduct of research, the Core will promote and protect the integrity of study data, while developing innovative programs and best practices that reduce or remove institutional impediments to clinical and translational research.

The tripartite mission of this core, therefore, is support, integration, and education. Partner institutions will build upon their experience and their history of collaboration, to provide direct support, assistance and consultation to research facilitators and researchers, share best practices and develop innovative programs. The regulatory processes will be streamlined to facilitate translational research between and among participating institutions, strengthen subject safety and autonomy, improve and expand training and educational programs.

The regulatory knowledge core has successfully implemented the use of the IRB of Record form to be utilized in research collaborations among our partner institutions to avoid duplication of efforts. This form designates one IRB from the participating institutions to be responsible for all IRB's obligations under its federal wide assurance.

Members of the Regulatory Knowledge and Support Core, with representatives from all partnering institutions, meet on a monthly basis to work on regulatory policies to expedite the review and approval process.

For more information please contact the Regulatory Knowledge and Support Core Facilitator at (646) 962-8308.