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Inter-Institutional Research (sIRB)

Purpose

Graphic: WIRB-Copernicus Group (WCG)

Historically, in many multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a Single IRB-of-record (sIRB) for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.

The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.

  • Non-federally funded research at TCNJ is now required to use a Single IRB-of-Record (sIRB) for inter-institutional research. The sIRB does not need to be TCNJ, but the TCNJ IRB needs to be notified of the research and receive verification of the designated sIRB.
  • Single IRB-of-Record (sIRB)- IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.  TCNJ chose to adopt this provision of the Common Rule early for all non-federally funded research Federally funded research may not apply this new rule until January 20, 2020.
  • TCNJ researchers who are engaged in inter-institutional research and already have IRB approval from another institution should upload the OHRP Template for sIRB into the iMedris system. Please note that TCNJ will only accept this form with appropriate signatures from the sIRB of record, and the sIRB of record must have an active Federalwide Assurance number (FWA).

Exemptions

Types of sites. This policy does not apply to the following types of participating sites in multi-site research:

  • VA sites
  • Foreign sites (though domestic sites of the same study must be reviewed by a sIRB)
  • Sites involving tribal nations
  • Sites for which review by the proposed sIRB is prohibited by a federal, tribal, or state law, regulation, or policy

Note that a study may involve sites that must comply with the policy and other sites that are not required to comply.

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