• Overview
• Program Contacts
• Inter-institutional Alignments
  • Reciprocal Common IRB Reliance Agreement
• Research Participants and Communities
  • Research Subject Advocacy (RSA)
• Investigational Drugs and Devices (IND/IDE)
• Quality Assurance/Quality Improvement (QA/QI)

Inter-institutional Alignments

The Regulatory Knowledge and Support Program seeks to reduce the regulatory burdens of clinical investigators and thereby support and encourage collaborative clinical and translational research. As such, where legally possible and desirable, the program seeks to provide support for the alignment or consolidation of policies, forms, and procedures among the participating institutions. When possible, such integrated and coordinated comprehensive resources and services can serve to ensure participant safety, a high level of research integrity, and compliance with regulatory requirements while reducing duplicative efforts and procedures.

Reciprocal Common IRB Reliance Agreement

The Reciprocal Common IRB Reliance Agreement is one example of such alignment. The agreement provides a pathway for requesting and accepting ceded IRB review for multi-center studies, thereby allowing one IRB to rely on the review of another IRB and reduce duplicative review. The ceding or accepting of review is not compulsory, but the Reciprocal Common IRB Reliance Agreement provides a foundation for such consolidation of review.