Toolkit has no worksheets or checklists dedicated solely to continuing reviews. Staff reviewers may consult HRP-313 to determine whether a continuing review may be reviewed under expedited procedures.

Complete HRP-402 when approving a continuing review under expedited procedures.

When scheduling a continuing review for convened board review, HRP-401 does not need to be completed UNLESS there are specific issues raised by the CR that need additional explanation or staff commentary. If this is the case, these should be entered in the Notes field. See IRB Member Summarizing CRs at IRB Meeting for types of notes IRB Members are expecting. There should be no need to edit other sections of 401 unless it has not previously been completed (I.e. the study was approved prior to Toolkit implementation and 401 has not yet been back-filled with a prior submission). In these cases, the CR staff analyst may need to review initial minutes and the application to prepare the checklist prior to scheduling.

Most minimal risk studies can be reviewed under expedited procedures. See HRP-313.

However, the CR assignment workflow is not designed to correctly assign all CRs full vs. expedited. There are some scenarios that cannot be caught until pre-review or are not worth including as a step since they do not occur very often. It would be on IRBSs to identify these during pre-review. 

Most common scenarios where the CR has been assigned as a full CR but could be expedited: 

• More than minimal risk study that is open to enrollment that hasn't actually enrolled anyone yet.
• Study team has selected the wrong study status. E.g., select enrollment closed but activities other than data analysis only or LTFU, but then they list data analysis only is occurring.
• Study was determined minimal risk by the IRB, but the MR question in the standard application does not reflect MR status therefore More Info does not reflect study is minimal risk. 

Most common scenarios where the CR has been assigned as expedited but would require full committee review: 

• Study team has selected the wrong study status. E.g., select enrollment closed but is open for data analysis only, but then they list sample and data analysis is occurring.
• Studies that are minimal risk but do not fit into expedited categories. E.g., minimal risk but has an IDE or IND.
• Studies that qualify for expedited review but for some reason they are being reviewed by the full committee. E.g., IRB monitoring progress, etc.

Continuing reviews that would otherwise undergo expedited review, can be referred for convened board review if necessary (the study raises specific concerns e.g. multiple study expirations, new or unreported reportable events, etc.).

More than minimal risk studies that are not limited to data and/or sample analysis or long-term follow up activities must be reviewed by the convened board. Any study that includes a revised IDB/package insert(s) must be reviewed by the convened board.

Review notes for unique submissions:

• Umbrella grant. These may be expedited; select expedited category 8b and add the following language to the ‘Additional Information’ text box:
  • This continuing review is for an umbrella training grant application that does not involve human subjects.
• HUDs. These may be expedited; select expedited review category 10 (other) and add the following language to the ‘Additional Information’ text box:
  • This is a continuing review of a humanitarian use device (HUD) protocol, the HUD is eligible for expedited continuing review pursuant to 21 CFR 56.110.
• NSR Device Studies. These may be expedited; select expedited review category 1b as an NSR determination is considered an abbreviated IDE and therefore not expeditable under category 9.
• SDACs. These may be expedited under categories 8(b) AND 8(c) for UW’s role as a data and/or sample analysis center for multisite studies where other IRBs oversee all interventions. Select BOTH categories 8(b) and 8(c) in HRP-402.  
  
  • For NON-FDA regulated SDACs: Use your judgment to determine if the following information still needs to be communicated to the study team. If so, please include the following language in the approval letter: “This study does not appear to be FDA-regulated. Based on recent interpretation of engagement guidance, this study may now be closed as long as there is no contractual (CTA) obligations requiring IRB review.”
• Studies that enroll subjects at UW and have progressed to the point of data and/or sample analysis only can be expedited under category 8(c).

Under campus policy, studies solely involving de-identified fetal tissue are no longer considered human subjects research. If a study involving only de-identified fetal tissue comes up for continuing review, the study team should be instructed to submit an application to the Stem Cell Oversight Committee (SCRO) and close their IRB application.

• If the study is still actively using/analyzing the de-identified fetal tissue, the SCRO application must be reviewed and approved before their IRB application is closed.
• If the study is in data analysis only, the IRB application may be closed once the SCRO application is submitted. 

Continuing reviews are reviewed based on expiration date, as opposed to order of submission. CRs are generally assigned to meetings approval-ready, as opposed to review-ready.

Scheduling:

• Aim to schedule CRs for the meeting of the week 2-3 weeks prior to their expiration date.
• If choosing between multiple meetings, IRBS should schedule the CR for the day they are also serving as back-up panel administrator. IRBS can also consider the overall size of the agenda.
• Aim for 4-5 CR limit on agenda.
  • As needed, CRs expiring later can be rescheduled for a later meeting to accommodate scheduling a CR expiring sooner. Chat full CR reviewers in this situation.
  • CRs submitted late would be scheduled as needed (likely without rescheduling other CRs already on the agenda). Contact the panel administrator if you need to assign a CR late to avoid study expiration.

Meeting Coverage:

• IRBSs will cover their own CRs if they will be the at the meeting (e.g., attending because you have something else on the agenda).
  • Assigning IRBS can also cover their own if the CR is complicated/problematic. (This would be rare.)
• If assigning IRBS will not otherwise be at the meeting, IRBS (who is also a full CR reviewer) serving as back-up panel admin will cover CRs.
  • Assigning IRBS should communicate anything problematic about CRs to the back-up panel admin covering CRs.
  • Back-up panel admin covering CRs are expected to review items prior to the meeting and reach out to assigning IRBS if they have questions.
  • Back-up panel admin covering CRs would communicate anything noteworthy from the meeting to the assigning IRBS. Assigning IRBS would complete post-meeting processing.

Some minimal risk studies may be excused from annual continuing review. HRP-314 describes when continuing review is required; and the following decision trees can be used to determine if a study meets the criteria to be excused from continuing review. For studies involving targeted enrollment of prisoners; regardless of which version of the common rule the study was approved under, consult with IRBD regarding the possibility of excusing it from continuing review).

See HRP-314 for criteria required to excuse studies approved under the Revised Common Rule from continuing review.

For studies subject to the pre-2018 requirements (i.e., approved under the old Common Rule; approved prior to 1/21/2019) these may be eligible for excusal from continuing review under Institutional Policy:

CR Decision Tree for studies subject to the pre-2018 requirements

Any study team members with expired human subjects training should be prompted during pre-review to complete their training or be removed from the application (if necessary, they can be added back once training is complete via self-service personnel change). If any training is outstanding when the CR is otherwise ready to approve/schedule, the continuing review should be held until the issue is resolved (certain exceptions can be made to avoid study expiration but those should be discussed with management).

Enrollment and withdrawal reporting should follow the guidance in the IM and instructions with the CR form. Exceptions can be made based on the context of the study and to maintain consistency across study submissions. See the IM for additional details as to how enrollment may be defined. These deviations in reporting should be noted in the CR workspace. A study team should aim to report consistently across the life of the study; any changes should be clearly described (e.g., corrections to previous reported numbers, etc.).

Specific nuances and notes about enrollment and withdrawal reporting:

• If the study involves extensive screening activities (e.g., numerous activities, screening visits over multiple days or requiring a lot of hours, etc.), participants can be counted as enrolled, instead of as screen fails. Those who do not pass screening activities would then need to be counted as withdrawals.
• Unrelated participant deaths that occur while on study should not be reported as withdrawals. We would consider the subject’s participation complete. (Older versions of the CR form asked about deaths; therefore, there may be residual/continuing errors regarding this; use your judgment to determine most consistent/understandable way to handle this based on the guidance above)
• Enrollment numbers are carried over from 5-year replacement applications (I.e. and any previous iterations of a study). Withdrawal numbers are not carried over and reset with each application.

As part of pre-review, staff analysts should determine if there are any unresolved reportable events or changes of protocol that are under review but not yet approved or that still need to be submitted, and if so, whether these may impact re-approval of the study.

See the Investigator Manual for an explanation of when revised IDB/package insert(s) may be submitted with continuing review and the information that needs to be submitted in the log. If the revised IDB/package insert(s) does not meet requirements to be submitted at CR, it should be removed (during pre-review or as a mod required by the IRB) and submitted as a change of protocol. Ultimately, revised IDB/package insert(s) require medical review, but the IRB Analyst may compare revisions to approved study materials (e.g., compare revised frequency of risks to approved consent form and protocol). All revised versions (since the version submitted at IR) should be submitted to the IRB.