516. Continuing Review: Submission Requirements for Expedited Review
Updated July 1, 2019
The Revised Common Rule (2018 Requirements) authorizes a burden reducing provision for discontinuing continuing review for some categories of research. Annual continuing reviews are not required for protocols that were approved by Expedited Review (unless the IRB determines otherwise), or if the current status pf 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 Request marking the current status of the project prior to the expiration date of the approval. RI staff will document the change in status and, if applicable, curtail future requests for continuing review form.
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, PIs should view the IRB approval letter for the new project or the last continuing review, whichever is more recent.
NOTE: Project amendments may NOT be submitted at the time of continuing review.
New Materials for Expedited Continuing Review
PIs must add the following new document to a Continuing Review package for the existing project:
- Continuing Review (Renewal) researcher form
Signature Requirements for Expedited Continuing Review
- PI signature for the Continuing Review package, obtained electronically through IRBNet
Materials Available for IRB Review
Researchers do not need to resubmit project documents because all of 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 1, Part II, 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.