Amendments and personnel changes

Applies to: SMART IRB SOPs (default under V3.0)

Under the SMART IRB SOPs, the Reviewing IRB reviews all amendments — study-wide and site-specific — and the Lead Study Team is the hub for submitting them and distributing the results. Institutions that have documented different policies follow those instead.

Who submits amendments? The Lead Study Team (or its designee) submits every amendment to the Reviewing IRB under that IRB's procedures. A Relying Site Study Team that needs a local amendment tells the Lead Study Team and gives it enough detail to prepare the submission.

Does the Relying Institution have a role? Yes. Before submission, the Relying Institution's Point of Contact must authorize three kinds of changes at its site:

1. Changes to the Site Investigator or key personnel — so the POC can confirm the person meets the institution's requirements and has completed required training, is qualified, and has adequate resources.
2. Changes that touch a Local Consideration or Other Consideration the institution raised when it agreed to cede review — including anything affected by state law. Not sure whether an amendment qualifies? The study team asks its POC; the Reviewing IRB asks the Relying Institution's POC.
3. Changes that reveal a new potential conflict of interest — the POC decides whether the institution needs to act and whether the conflict affects its decision to cede.

Relying Site Study Teams report these changes to their POC through their institution's usual process; once the POC has authorized them, the site coordinates with the Lead Study Team for submission.

How do all sites learn about approved amendments? The Overall PI and Lead Study Team (or the Reviewing IRB, if the Overall PI and Lead Study Team have documented that arrangement) distribute the IRB-approved versions of all study documents — protocol, consent and authorization forms, recruitment materials — to every site at initial approval, continuing review, and each amendment. Sites must follow the approved documents that apply to them.

What if a change affects only some sites? The same process: the Lead Study Team submits it and communicates the outcome to the affected sites.

Personnel listed in the Reliance System are for access, notification, and documentation. Keeping them current (which study teams and Site Admins can do at any time) does not replace the personnel-change amendment process above. One practical benefit: when a Site Investigator changes, the Agreement does not require re-executing the reliance arrangement, and the determination PDF in the Reliance System updates automatically with no countersignature.

See also - The Communication Plan - Local Considerations and Other Considerations - COI for non-federal Relying Institutions