IRB

With the collaboration of IRB leaders across its eight founding institutions, PEDSnet has made significant progress in developing regulatory policies and tools to facilitate research across the network.  All PEDSnet institutions endorse the PEDSnet Single Institutional Review Board (IRB) Policy which aims to establish a single IRB framework for multi-institutional research studies. The Single IRB framework provides a vehicle for investigators proposing multicenter studies to request "ceded review," that is, to request that the IRBs on a multicenter study rely on the review of one IRB, and for the IRBs at the participating institutions to elect to do so on a protocol-by-protocol basis.

Building from an existing agreement developed for use with Boston Children’s Hospital, Cincinnati Children's Hospital Medical Center, and the Children’s Hospital of Philadelphia, PEDSnet adapted and executed a Master Reliance Agreement among all its members. This agreement sets forth the respective authorities, roles, and responsibilities of each party when a ceded review arrangement is determined to be acceptable. The National Pediatric Research Alliance (NPRA) is an expansion of PEDSnet efforts, and aims to foster and grow relationships among leading institutional IRBs, with a special focus on pediatric focused institutions. The NPRA now represents 22 member institutions around the country.

Furthermore, with the NIH issuance of a final policy on the use of a Single IRB taking effect September 25, 2017, PEDSnet along with other PCORnet collaborative network entities are moving their sites toward SMART IRB participation.  In doing so, PEDSnet and other research networks, will be well poised to meet the mandates and fully participate in NIH funded multi-site trials.