Review Process
The IRB office utilizes an initial pre-review screening process, during which an IRB analyst reviews each submission for completeness and compliance.
The analyst may ask the PI to make changes to the submission before it is reviewed by the IRB (pre-review). The IRB reviewer(s) may also ask for changes or clarifications, which the IRB analyst will communicate to the research team after IRB review (post-review).
Notes:
- New studies must meet minimum submission standard requirements before they undergo the pre-review screening process.
- The number of IRB reviewers varies based on the level of review the submission requires. Full committee review studies are reviewed by the IRB committee at a convened meeting, while expedited and exempt studies are reviewed by a small number of IRB reviewers outside of an IRB meeting.
Review Outcomes
Outcome in ReGI | What it means | What it was called in iRIS |
Approve | The IRB determined the submission satisfies all applicable requirements. The study or requested activity is approved. | Approve |
Modifications Required to Secure Approval (MRTSA) | The IRB requires changes or additional information before the submission can be approved. The study team must address reviewer comments. | Revisions Required |
Deferred | The convened IRB determined that significant changes or additional information are needed before it can make an approval decision. The revised submission must return to the convened IRB for another review. | Return for Additional Information |
Disapprove | The IRB determined that the submission does not meet the criteria for approval and cannot be approved. | Disapprove |
Table (optional; institution-configured) | The IRB postponed a decision until additional information is available or discussion can continue at a future meeting. No approval decision has been made. | Table |
Expiration Dates
When applicable, an expiration date is clearly listed on the approval letter and on the ReGI study workspace. More information on how the IRB calculates expiration dates is available on the Study Expiration Dates and Extended Approval Criteria page. Although the ReGI system sends courtesy renewal reminders prior to the expiration date, it is the investigator's responsibility to keep track of the expiration date and initiate the continuing review process sufficiently early.
Approval Documentation
Approval Letters
- The UCSF approval letters issued via ReGI are not signed by a member of the IRB. However, these letters and other available information comply with all regulatory requirements. Similar letters are in use at other institutions and the letters comply with past guidance we received from the Association for Accreditation of Human Research Protection Programs (AAHRPP). We will not issue separate letters complying with additional requests from sponsors.
- The IRB approval letter lists the consent document(s) and other study documents that were reviewed with the submission. Please note, it does not list the study SmartForm.
- ReGI a closed system and falls under FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures).
- We have additional information for sponsors about the UCSF Federalwide Assurance (FWA) and IRB membership.
Approval stamps on consent documents
- Approved consent documents in ReGI will receive an approval stamp. To accommodate the stamp, each consent document should have at least a 1.25" top margin and the upper right-hand corner should be blank.
- Other study documents will not receive an approval stamp.
- Note: Prior to the implementation of iRIS in early 2010, the IRB did not stamp consent forms but instead listed the approved versions on the approval letter.