The IRB-SBS protocol review process is based on federal regulations 45 CFR 46 and UVA HRPP SOPs. Once a protocol is submitted to our office, the IRB-SBS staff "pre-review" the protocol in order prepare it either for an Expedited/Exempt review (administrative review conducted by a Board member) or Full Board review (review conducted by the conviened IRB-SBS board). iProtocol facilitates every step of the review process from protocol creation, submission, review, and approal. As the protocol moves through the review process, the principal investigator will be notified of the review status and any actions required by the PI such as revising the protocol.
The protocol review process starts with creating and submitting a protocol. For more information, see Create an iProtocol.
When the IRB-SBS receives a protocol, the Protocol Manager (PM) does an initial check of the protocol to make sure that everything was submitted properly. The PM assigns the protocol to the Pre Reviewer.
A Pre-Reviewer (PR) is a member of the IRB-SBS staff tasked with checking the accuracy of the protocol. During the pre-review, the PR reads the protocol in its entirety to ensure that the protocol includes all of the information necessary for the IRB reviewer to conduct an accurate review. The pre-reviewer will make comments on the protocol and then "return" the protocol to the principal investigator (PI) who can then review the comments, make necessary changes, and then "submit" the protocol back to the PR. This process may take a couple of rounds or may not be necessary at all depending on the level of edits needed in the protocol. Once the PR decides that the protocol is ready for IRB review, the PR makes an initial recommendation regarding the protocol's level of risk; if the protocol is minimally risky and meets other requirements for expedited or exempt review, the PR will assign it to an IRB-SBS board member (IRBR) for review. If the protocol is more than minimally risky, the PR will assign the protocol to a full board meeting for full board review.
An IRBR assigned to a protocol for expedited or exempt review will confirm the PR’s recommendation. If the IRBR doesn’t agree with the PR, he can send the protocol to a full board meeting instead. An IRBR cannot determine that a protocol is “not approved”; rather, this determination is only made by the full board. The more likely scenario is that the IRBR will review the protocol and determine that the protocol will either meet one of the following determinations:
When a protocol is assigned to a full board meeting, it is assigned to a primary and secondary reviewer who review the protocol in detail and report to the Board regarding their findings but all members of the Board review all of the protocols assigned to a meeting. During the meeting, each protocol is discussed and the Board votes on a determination. If needed, the Board makes recommendations regarding a protocol which are then communicated to the PI after the meeting.
The full board determinations are as follows:
The PR communicates any revisions required by the board review to the PI and the PI is able to review the recommendations and edit the protocol accordingly. If the protocol is deferred, it will be sent back through the board review process (either to the expedited/exempt reviewer or to the next full board meeting). If the protocol is “approved with conditions,” once the PR receives a protocol that meets the conditions, the PR can finalize the approval. The Protocol Manager verifies that the protocol is signed by all the required parties (PI, Faculty Sponsor--if the PI is a student, Department Chair, and IRB-SBS Chair). She also verifies that the correct CITI training is complete. When all of these benchmark items are complete, the Protocol Manager documents the protocol as “approved” and the PI receives an email which includes a link to the “approval certificate.” The protocol is marked as “approved” in the iProtocol Protocol Management page.
Once the protocol is “approved” that version of the protocol is locked. Consent forms can be accessed but shouldn’t be modified from the approved version. All other documents uploaded into iProtocol are accessible as well; iProtocol acts as a secondary storage for your study documents, helping to keep you organized if something is upended on your personal device. Maintaining your protocol going forward is done in iProtocol as well—see Modifications and Continuation for more information. You can also use the protocol as a template for future protocols by using the “copy” feature.