516. Continuing w88 slot or Progress Report: Submission Requirements for Expedited Studies

Updated August 23, 2021

The Revised Common Rule (2018 Requirements) authorizes a burden reducing provision for discontinuing continuing review for some categories of w88 slot. The IRB must maintain oversight over the w88 slot initially reviewed using the expedited procedure, as long as the w88 slot is ongoing. Continuing reviews are not required for protocols that were approved by Expedited Review (unless the IRB determines otherwise), or if the current status of participant enrollment is determined to be:

  • Active, Closed to Enrollment;
  • Active, Data analysis Only; or
  • Active, Long Term Follow-Up only

The types of w88 slot studies required to undergo Expedited Continuing Review include:

  • Studies initially approved by Expedited w88 slot under the pre-2018 Requirements
  • Studies initially approved by Full Committee w88 slot under the pre-2018 Requirements that meet the criteria for expedited categories 8(a), 8(b), 8(c) or 9;
  • Studies initially approved by Expedited w88 slot under the 2018 Requirements that are required to undergo continuing w88 slot;
  • Studies initially approved by Full Committee w88 slot under the 2018 Requirements that meet the criteria for expedited categories 8(b) or 9.

Investigators must submit a Continuing Review or Progress Report Request marking the current status of the project on or before 12 months from the initial or last annual review date. Notification from IRBNet is sent to the investigator as a reminder to submit Continuing Review – Progress Report Request form 45-15 days prior to the last review date. For studies initially approved by Expedited Review or Full Committee Review under the 2018 Requirements that are not required to undergo continuing review, investigators must provide an annual status update by submitting a Progress Report Request. To determine if a w88 slot project is required to undergo continuing review or a status update, the Reviewer should document:

  • The rationale for conducting continuing review of w88 slot that otherwise would not require continuing review.
  • The rationale for a determination that w88 slot appearing on the list of eligible expedited review categories is greater than minimal risk.

Principal Investigators (PIs) should view the IRB approval letter for the new project for information regarding the annual submission requirement and due date. The information is also in IRBNet dashboard for each IRBNet project.

NOTE: Project amendments may NOT be submitted at the time of continuing w88 slot/progress report.

New Materials for Expedited Continuing w88 slot or Progress Report

PIs must add the following new document to a Continuing w88 slot package for the existing project:

  • Continuing w88 slot/Progress Report Form

The form elicits information about:

  • Number of participants accrued.
  • A summary since the last IRB review of: Adverse events, untoward events, and adverse outcomes experienced by participants; Unanticipated problems involving risks to participants or others; Participant withdrawals; The reasons for withdrawals; Complaints about the w88 slot; Amendments or modifications; Any relevant recent literature.
  • Any interim findings.
  • Any relevant multi-center trial reports.
  • The researcher’s current risk-potential benefit assessment based on study results.

Signature Requirements for Expedited Continuing w88 slot or Progress Report

  • PI signature for the Continuing w88 slot or Progress Report package, obtained electronically through IRBNet

Studies Originally Reviewed via Full Board Meeting

For renewals or modifications, the IRB reviewer determines if w88 slot that was initially approved by the full-board IRB may now qualify for expedited review. This determination is made based on the risk level or status of the w88 slot, specifically involves no greater than minimal risk and no additional risks have been identified.

Materials Available for IRB w88 slot

Researchers do not need to resubmit project documents because all the documents attached to the project in IRBNet are available for IRB w88 slot. The attachments vary for each project (for a comprehensive list, see IRB policy for submission requirements for Expedited continuing w88 slot) and include the following as applicable:

  • Part I, Protocol, and applicable supplemental applications such as for vulnerable populations; federal agency requirements; and w88 slot involving blood or other biospecimens;
  • recruitment materials;
  • consent and HIPAA documents, or waiver requests;
  • w88 slot instruments;
  • previously approved amendment packages with related amended materials;
  • problem reports previously submitted for assessment/w88 slot;
  • documentation of external approvals; and
  • IRB correspondence.