About SMART IRB
Eligibility to Participate
- Do affiliated institutions that are legally separate but covered under a single FWA need to join SMART IRB individually?
- If one institution provides IRB review for several affiliated but legally separate institutions do all institutions need to join individually?
- If my institution’s FWA specifies that we rely on the IRB of another legally separate institution, do both institutions need to join SMART IRB?
- If a group of affiliated institutions with separate FWAs (e.g., a university-hospital system) wants to participate in SMART IRB, can one member of the group join on behalf of all?
- Does my institution need to have an IRB in order to participate in SMART IRB?
- Can government agencies that conduct or review research participate in SMART IRB?
The SMART IRB Reliance Model
Scope of Covered Research
- Is the SMART IRB Agreement in compliance with the revised Common Rule, including the cooperative research provision (45 CFR 46.114(b))?
- Can SMART IRB Participating Institutions participate in other IRB reliance agreements?
- How do institutions determine which studies will use the Agreement?
- Are institutions required to cede review or serve as a Reviewing IRB?
- In order to satisfy the SMART IRB eligibility criteria, does my institution need to require IRB review and institutional oversight for exempt human subjects research?
- Can SMART IRB be used for exempt studies?