552. RI Assessment for Completeness and Review Type
Updated July 1, 2019
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 RI staff member; some, may be assigned to the RI 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 (RI staff or IRB member)
- Administrative Review (RI 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.
IRBNet applications should be complete and “review-ready” when they are submitted to IRBNet. Failure to submit a “review-ready” application will delay the IRB review process. Each application will undergo verification of submission standards by RI staff. Incomplete submissions will not be assigned for review until all materials are complete. If the application is determined to have major deficiencies, it will be returned to the PI and marked withdrawn in IRBNet. RI staff will prepare written correspondence in IRBNet or email to PI with detailed information regarding the deficiencies identified in the application. Examples of major deficiencies include:
- Missing consent documents or consent in the wrong format
- Substantial errors (incomplete, incorrect or unreadable responses) in application forms
- Significant inconsistencies within or between documents (e.g., consent form does not match protocol)
- Missing important attachments that are needed for the review (e.g., recruitment materials, non-standard instruments, etc.)
For complete submissions that require Full Committee Review, RI 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, RI staff assign the project/package to senior RI staff (or IRB member when warranted or required). For complete submissions that are eligible for Expedited Review, RI staff assign the project/package to an IRB member who is qualified to complete reviews by expedited procedures.