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Children's Hospital of Orange County (CHOC), MemorialCare Health System (MHS) and UC Irvine (UCI) - CMU IRB Reliance

Children's Hospital of Orange County (CHOC), MemorialCare Health System (MHS) and UC Irvine (UCI), established an IRB Reliance agreement that allowed for human subjects research to be reviewed by a single IRB rather than submitting for IRB approval at each institution where the research would take place. This agreement was intended to simplify and streamline the IRB review process by facilitating single-IRB review. The agreement was referred to as the CMU IRB Reliance (pronounced SEE-MOO). This agreement applied to IRB review; it did not affect other institutional reviews required by each institution (e.g., feasibility, conflict of interest, radiation safety, etc.).

In an effort to promote a more streamlined process, effective in 2020, CMU has agreed to utilize the SMART IRB agreement instead of the prior CMU IRB Reliance process.  SMART IRB is a platform designed to ease common challenges associated with initiating multisite research.  Important note: SMART IRB is not an actual IRB that provides regulatory approval. SMART IRB provides a roadmap for institutions to implement the Single IRB Review requirements. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). For more information, visit SMART IRB.

Researchers can initiate a CMU IRB Reliance through the UCI IRB Application process.  Note: Requests for collaborating sites to rely on the UCI IRB must be made via a formal modification to the UCI IRB approved study.  Reliance agreements where UCI serves as the IRB of record will not be considered at initial review due to the amount of time involved as this often protracts the initial IRB approval timeframe for the UCI site.

Completion of Appendix U (UCI will serve as the IRB of record) or Appendix R (UCI will rely on CHOC or MHS) is also required.

UCI Documentation:

(Note: In an effort to promote a more streamlined process, effective in 2020, UCI will utilize the SMART IRB agreement instead of the CMU IRB Reliance.)

CHOC & MHS Consents:


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