516. Continuing Review 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 research. The IRB must maintain oversight over the research initially reviewed using the expedited procedure, as long as the research 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 research studies required to undergo Expedited Continuing Review include:

• Studies initially approved by Expedited Review under the pre-2018 Requirements
• Studies initially approved by Full Committee Review 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 Review under the 2018 Requirements that are required to undergo continuing review;
• Studies initially approved by Full Committee Review 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 research project is required to undergo continuing review or a status update, the Reviewer should document:

• The rationale for conducting continuing review of research that otherwise would not require continuing review.
• The rationale for a determination that research 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 review/progress report.

New Materials for Expedited Continuing Review or Progress Report

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

• Continuing Review/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 research; 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 Review or Progress Report

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

Studies Originally Reviewed via Full Board Meeting

For renewals or modifications, the IRB reviewer determines if research 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 research, specifically involves no greater than minimal risk and no additional risks have been identified.

Materials Available for IRB Review

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

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