As of January 25, 2018, the NIH requires the use of a single IRB [sIRB] for the verification of NIH-funded multi-site studies, in which each website applies the same protocol with non-exempt research for humans, whether supported by grants, cooperation agreements, contracts or the NIH research program. This directive applies only to national websites. Implementation of the NIH policy should reduce unnecessary administrative burdens and systemic inefficiencies, while ensuring adequate protection for individuals. The directive defines „multi-site“ as two or more sites. This depends on the nature of the submission and demand (Cede/Rely) required for the study. To process a Nu IRB application as an IRB protocol, we must ensure that the site is included in the research and that the protocol accurately reflects the role of each site involved. The external site should also have a Federal Wide Assurance (FWA) before the agreement can be implemented. For studies that request the Nu IRB withdrawal review at an external IRB, we should review the protocol, approval document and all other relevant study documents. In addition, the scientific staff preparing the submission in the eERB should be trained in the submission requirements of an external IRB study.
A reliance agreement (also known as the Institutional Authorization Agreement or IAA) is an agreement signed by two or more institutions participating in the same human research project. The agreement allows one or more institutions to transfer the audit to another central or individual IRB. In general, this means that only an IRB will re-examine a single project for several collaborators in all institutions. Choose a tab below to learn more about when and how to incorporate a trust agreement into your project. If it has been determined that the IRB`s confidence application form contains all the necessary details, the next step is to implement an IRB Authorization Agreement (IAA) between the two institutions. The ILO process usually takes several days, but can sometimes take several weeks depending on different factors (for example. B the complexity of the agreement, the availability of signatories, etc.).