NIH will expect the following new information in grant applications for multi-site research on and after January 25, 2018:
A plan describing the use of a sIRB. The plan should identify the IRB that will serve as the sIRB and should address any requests for exceptions from the policy. See the NIH sIRB plan instructions for further details on what needs to be included.
Letters of support from the FIU Office of Research Integrity and each of the sites that will rely on the sIRB. Each site participating in the study must document its agreement with the IRB review arrangement in a letter of support. This letter is not the same as the formal IRB reliance agreements that may need to be established after the grant is awarded. See the section above for more information about the letters of support.
IRB fees that will be charged as direct costs. Depending on the sIRB that is selected for your study, there could be fees involved.
A description of the resources (personnel, budget) you will need to manage IRB communications. ORI anticipates that studies with more than a handful of sites will require significant additional staffing resources to manage the complex communications and document management associated with the use of a sIRB and with IRB-related coordination across sites. This role is being called the “IRB Liaison” by HSD and at many other institutions nationwide. It is typically a staff member on the research team at the lead site.