We want to hear from you! Take the survey.
How do you use It’s Your Yale? How can it be improved? Answer for a chance to win Yale swag.
sIRB Plans
Applicants are expected to include a plan for the use of an sIRB in the grant applications and contract proposals submitted to the NIH (for due dates on or after January 25, 2018). For details, see Section 3.2 of the PHS Human Subjects and Clinical Trials Form Information Application Guide.
In general, your plan for the use of an sIRB should include the following elements:
- Description regarding how you intend to comply with the sIRB policy;
- Name of the IRB that will serve as the IRB of record;
- Statement that all identified participating sites have agreed (or will have to agree if sites have not been selected at the time of the grant application) to rely on the proposed sIRB;
- Statement that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites (the actual reliance agreements should NOT be included with the grant application);
- Brief description of a communication plan between the sites and the IRB;
- Description of which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.