SRS Protocol Review Flow Sheet

IACUC/Basic Research CoMIRB/Clinical Research Notify Teri Armstrong and Angie Bartolino of pending Safety Documents and ACORP 1 st of the Month

(if, and only if done)

Deadline for RPSS and supporting documents (Background, MSDSs, VA Consent, etc.)

(if, and only if done)

Submit RPSS (to SRS), ACORP (to IACUC), 15 th of the Month and accompanying Documents (MSDS, Copy of Grant for project)

(if, and only if done)

Note: Amendments for “short” turnaround: Immediate review prior to COMIRB, submit SRS Update Form at least 48 hours prior to COMIRB deadline.

SRS Meeting Review 4 th Thursday of the Month SRS Meeting Review IACUC Full Protocol Review

(when/if both SRS and IACUC have approved)

1 st Tuesday of the next Month R&D Meeting Review 2nd Wednesday of the Month

(if approved)

R&D Meeting Review

Important information to remember: 1. ALL SRS documents should be submitted at the same time, in the same email

. We handle approximately 30 applications per month, with an average of 4 documents per submission. Tracking all these separately, particularly as this is NOT in our primary job description, is tedious and time consuming.

Only Word copies of RPSS documents will be accepted.

2. Regarding the new Expedited IACUC Review procedure, all IACUC ACORP documents, including SRS RPSS and other necessary safety documents, must be submitted to Teri Armstrong in a single email by the 15 th of the month.

If the entire packet is not present, the protocol will not be reviewed.

2. All deadlines on the flowchart are immutable; if you miss the deadline your protocol will not be considered until the next month’s review cycle.

There are no emergencies, just poor planning.

3.

Amended protocols (IACUC or CoMIRB) that are not consistent with the currently approved RPSS (or that do not have an associated RPSS) need to have a revised or new RPSS that is consistent with the proposed work.

Example: if your IACUC protocol/RPSS do not specify blood and animal tissue removal, but you are now amending the protocol to take blood samples, you will have to revise the RPSS to indicate new risks and appropriate methods to alleviate the risk. Don Lawrence can help you with such revisions.