Note: It is not uncommon for new authorization agreements to take months. It is recommended that researchers keep this in mind when considering an application for dependency [either the PSU requirement as an audit or confidence in the IRB]. Institutions disagree on whether and how they will use the binding agreements. The findings regarding the binding agreements are very specific to each institution and each protocol. For example, many IRBs will not enter into such agreements for exempt projects. Other institutions may have specific types of verification and standards in place for their human research program and will not participate in reliance activities for projects using these control structures. The OHRP and the FDA allow an IRB to rely on the verification of another IRB. If this is the case, the two institutions enter into an agreement called either a cooperation agreement, an NI approval agreement or an NI trust agreement. These agreements are concluded between a review niRB and one or more original entities, and the roles and responsibilities of the parties involved are delineated. The agreements may apply to a single research study or several studies (for example.
B a master reliance agreement). The NIH, study consortia and some support organizations have increasingly encouraged themselves to characterize the IRB Central IRB as an audit for all participating sites as part of multi-center research studies. Currently, CHOP can only enter into reliability agreements to rely on another U.S.-based iRB. The information on this page therefore applies to trust agreements between institutions and U.S.-based IRBs. Since May 25, 2017, the NIH has required all national sites participating in multi-center research studies (where each site performs the same protocol) to use a single IRB (sIRB). The final NIH Directive on the use of a single institutional multi-site research review committee applies to research without any exempt human subject, whether supported by grants, cooperation agreements, contracts or the NIH Intramural Research Program. It does not apply to professional development, research training or scholarships. This directive applies to all competing grant applications (new, renewed, revised or reinstalled) with receipt dates on May 25, 2017 or after May 25, 2017.
The directive was originally due to come into force on 25 May 2017, but NIH has published an extension of the transposition date which has postponed entry into force until 25 January 2018 (the directive is now in force). This site provides instructions on the different types of agreements that are often used in research on human issues at Penn. Please note that some of these agreements require evaluation by offices outside the IRB. Patrick Stanko is the IRB`s main interlocutor on general issues relating to agreements.