552. Research Integrity Assessment for Completeness and Review Type

Updated July 13, 2021

Assessment for Completeness and Review Type

University and Affiliate faculty, students, and staff use IRBNet to submit new projects, continuing review and amendment packages, closures, IRB-requested changes or revisions; and to report problems. Once submitted to IRBNet, projects/packages are assigned to a Research Integrity staff member; some may be assigned to the Research Integrity Director. The Director/staff pre-reviews each project/package for completeness and appropriate review type and coordinates the review.

The IRB policy for review types is used to determine the type of review required for a specific project/package or research activity. IRBNet offers four review types:

• Full Committee Review (convened IRB)
• Expedited Review (one or more qualified IRB members)
• Exempt Review (Research Integrity staff or IRB member)
• Administrative Review (Research Integrity staff or IRB member)

Completeness is assessed in part by referring to the IRB Policy Manual Submission Requirements section (for requirements by submission and review types), or the IRB policy for reporting problems.

Incomplete Submissions

For incomplete submissions, Research Integrity staff contact the PI and contact person (if identified) by telephone or email and inform them of the missing documents or information.

• Incomplete submissions eligible for Administrative, Exempt, or Expedited Review will not be forwarded for review until determined to be complete.
• Incomplete submissions requiring Full Committee Review that remain incomplete within a few days of an IRB meeting, will be re-assigned to the agenda for a subsequent meeting.
• If assigned to an agenda and found incomplete during the meeting, IRB approval will be deferred either for subsequent review at a convened IRB meeting or for expedited review if the IRB determines and documents the research qualifies for expedited review.

NOTE: Rarely, for Administrative, Exempt, or Expedited Review a reviewer may be notified of the review assignment for an incomplete project/package. Research Integrity staff inform the reviewer the package is incomplete. Research Integrity staff notify the reviewer once the missing materials are available in IRBNet. Approval is withheld until the complete package is reviewed.

Complete Submissions

For complete submissions that require Full Committee Review, Research Integrity staff assign the project/package to the next IRB meeting agenda and assign reviewers. If the IRB does not have the requisite expertise to review the research at the next scheduled meeting, the review may be postponed until an individual with the necessary skills/knowledge is available to attend a meeting or submit a consultant review.

For complete submissions that are eligible for Administrative or Exempt Review, Research Integrity staff assign the project/package to senior Research Integrity staff (or IRB member when warranted or required). For complete submissions that are eligible for Expedited Review, Research Integrity staff assign the project/package to an IRB member who is qualified to complete reviews by expedited procedures.