Does the Relying Institution have a role in the review of amendments (changes of protocol)?

Yes, if the SMART IRB Standard Operating Procedures (SOPs) are applied. Although the Reviewing IRB will conduct amendment reviews and other changes in research in accordance with the SMART IRB Agreement and SOPs, applicable federal regulations, and its own policies and procedures, the Points of Contact (POCs) at Relying Institutions must authorize submissions for following types of changes:

• Changes in Site Principal Investigator (PI) or key personnel, in order to ensure these personnel meet the Relying Institution’s institutional requirements;
• Changes that appear to affect any state law or “local consideration” issues that a Relying Institution noted as part of its agreement to cede review; or
• Changes that indicate a new potential conflict of interest.

Study teams from a Relying Institution will report changes in personnel and potential conflicts of interest to their institution’s POC via the procedures and policies established by the Relying Institution.