Step 4: After You Submit

After submission, each study is assigned a review level.  Studies generally fall into one of three review categories: exempt, expedited, or committee review.

Exempt and expedited studies are reviewed by an experienced IRB member. Committee review level studies go to the IRB committee for review.

Materials Reviewed

If a study is determined to be exempt, in addition to the information provided in the CATS IRB Submission Form, the IRB will generally review:

  • Study protocol (commonly HRP-591),
  • Data collection Instruments,
  • Study Team Member Qualifications (HRP-509), and
  • in certain circumstances, consent forms and/or recruitment materials.

If a study is reviewed at the expedited or committee level, the IRB will review all of the above and may require other supporting materials. When applicable, the IRB will review external (and internal, if such documentation exists) grant proposals/applications for congruency with the study protocol.

The IRB will not approve a submission or make an exempt determination until all study team members have completed the required training in CITI.

Clarifications Requests

IRB Analysts or the IRB Committee may request clarifications or revisions during the pre-review or review of a submission. Such requests will come in the form of a "Clarification Request" action found under the "History" tab of the submission in CATS IRB, pictured below. 

History CR requested.png

The Clarification Request function is the official communication from the IRB. The study team must respond to requests for clarification within CATS IRB. While email exchanges or phone calls with an IRB Analyst may be helpful for understanding clarifications, the study staff must submit changes in CATS IRB to fulfill Clarification Requests.

Time from Submission to IRB Approval or Determination

Time from initial submission to an IRB approval or determination depends on a number of factors, such as the quality of your submission, clarifications needed, the complexity of your study, the study population, and the level of review. The average timeline from the initial submission is listed below; this is business days with the IRB office and does not include time when the study is with the study staff:

  • Exempt: 10 to 15 days
  • Expedited level: 20 to 25 days
  • Committee level: 25 to 35 days

What's Next?

Move on to Step 5 to learn about managing submissions after IRB Approval, clinical trail requirements, and closing a study.