A trust agreement avoids an initial double review of the IRB and ongoing monitoring when multiple CISRs are responsible for the same search protocol at multiple sites. SMART IRB: The SMART IRB Trust Framework Agreement was launched in 2016 to harmonize and streamline the IRB`s review process for multi-site studies. It builds on a study-by-study basis, clearly defines the roles and responsibilities of the institutions that rely on it and the IRB review, and eliminates the need to sign trust agreements for each study [i.B. a non-SMART IRB agreement]. More than 500 institutions have already signed this agreement and are actively using it as a basis for dependence on multi-site projects. Under this agreement, the Review IRB is where the excess weight of the research is conducted. Please call the IRB if you are unsure where the excess weight of the research is considered to have been conducted. SMART IRB is used as the primary trust agreement when USC IRB serves as the IRB registration. If the trust institution is not connected to SMART IRB, the USC IRB Authorization Agreement FORM is completed. The first step in the Reliance agreement process is to complete a Reliance application.

The JHM IRB Reliance team will review the information provided in the Reliance Request survey and contact you with the next steps/instructions. The process works by having the entire RESEARCHER request that one of the CISRs – either Penn IRB or CHOP IRB – serve as the examination IRB for both institutions. The application may be submitted at the time of the first submission for approval or as part of a subsequent amendment. Research conducted at the Pennsylvania Hospital may also be included in this agreement. If the CHOP IRB is to be the examining IRB, the CHOP investigator submits the study (or the amendment to add the University of Pennsylvania as a site) to the CHOP IRB (in eIRB) and indicates in the application that it is a multicenter study for which “CHOP will serve as the review IRB for one or more other institutions.” The Penn CHOP determination form duly completed and signed by the examiner must be attached to the application. If the CHOP IRB agrees to serve as the examination IRB, a chair or agent of the IRB signs the determination form and forwards it to the penn IRB. As of May 25, 2017, the NIH requires all national sites participating in multicenter research studies (where each site conducts the same protocol) to use a single IRB (sIRB). The NIH`s final guideline on the use of a single institutional review committee for multi-site research applies to non-exempt research in human subjects, whether supported by grants, cooperation agreements, contracts, or the NIH`s intramural research program. It does not apply to professional development, research training or scholarships. This policy applies to all competing grant applications (new, renewed, revised or re-submitted) that are received on or after May 25, 2017.

The directive was originally scheduled to take effect on May 25, 2017, but the NIH issued an extension of the transposition date that postponed the effective date to January 25, 2018 (the directive is now in effect). (___) This agreement applies to all human subjects covered by institution B`s FWA. Negotiating a Reliance agreement can take weeks or even months. To speed up the process, CHOP has entered into several trust framework agreements. Details of the individual agreements can be found below. A trust agreement, also known as an IRB Authorization Agreement, is a document signed between two institutions that allows the IRB of one institution to rely on the IRB of another institution to review and approve research involving human subjects. The signed agreement defines the roles and responsibilities of the parties involved. This allows a single IRB to review research involving human subjects for two or more institutions, as the trusted institution assigns the examination to the examination institution. The University of the Utah Valley has agreed to act either as a registered IRB so that other institutions can assign the exam to UVU-IRB, or as a trusted institution that assigns the exam to an external IRB, depending on the research protocol to be reviewed. Download the researcher`s Reliance checklist to follow the instructions below. CHOP has entered into a religious master`s agreement with Columbia University (CU) for NAMDC research studies. Columbia University will be the examination IRB for these studies.

The NAMDC Central IRB Agreement Determination Form must be completed by the CHOP Investigator who relies on the UC IRB (IRB Review). The signed and completed assessment form must be uploaded to the eIRB as part of the IRB application. SMART IRB offers several options for documenting the dependency between institutions for a particular research study. .