If the stipulations are not addressed within 30 days, the PI will have to resubmit the entire continuing review package for another review. Changes to the protocol or consent and assent documents should be highlighted in one copy of the revised continuing review package. Depending on the extent of the stipulations, the IRB Chair may review and approve the revised package without full committee review. The IRB agrees that approval cannot be granted until further information is provided or specific changes are made in the continuing review package. The IRB sends a notice to the PI identifying the reasons for disapproval of the protocol.
Disapprovals are definitive.
The PI may submit a new protocol that reflects due consideration of the reasons for disapproval of the old one. Upon receipt of a completed continuing review package, a protocol specialist in the PCSC reviews the package to assure that all required documents are included, all elements and questions have been addressed, and all signatures and initials are present. The protocol specialist works with the Institute PC, via telephone and electronic mail, to resolve any deficiencies promptly. However, it may be necessary to return the continuing review package if it requires major correction. The protocol specialist then updates the protocol consent and assent documents on the intranet.