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

 

University Park IRB Meeting Schedule

Meetings will call to order at 12:30 p.m. on the following dates:

2019 2020
  •  August 22
  • September 12
  • September 26
  • October 24
  • November 21
  • December 12
  • January 23
  • February 27
  • March 26
  • April 23
  • May 14
  • May 28
  • June 25
  • July 23
  • August 27
  • September 10
  • September 24
  • October 22
  • November 19
  • December 10

 

PLEASE NOTE: Due to the confidential nature of the information discussed, IRB meetings are not open to the public. Arrangements can be made for individuals or groups to observe an IRB meeting under certain circumstances.  Meetings may be canceled if there is not a quorum or if there are no submissions to be reviewed by the IRB at the time that the agenda is created. 

What's Next?

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