Step 4: After You Submit
When you submit a study in CATS IRB, your submission is automatically routed to one of the two IRB Offices based on the home department of the Principal Investigator. Submissions are then assigned to an IRB Analyst based on the first letter of the Principal Investigator’s last name. Your IRB Analyst is your primary contact for each study you submit and will generally remain your contact through the life of a study open with the IRB.
IRB Analysts can help you as you prepare your submission materials, and when you submit a study, they do an initial pre-review of the materials you submitted. They also serve as designated IRB reviewers on studies that do not require committee review. If your study will be reviewed at the committee level, your IRB Analyst will pre-review your submission and facilitate a sub-committee review, which occurs before the committee convenes to review the submission. Your IRB Analyst will be your primary contact as you move through the committee review process.
Any questions that you have throughout the life of a study should be directed to your IRB Analyst. Find your IRB Analyst.
All official communication regarding your study will be documented in CATS IRB. Your IRB Analyst may leave comments for you, and you can leave comments for them as well in what is referred to as the “history log” within each study. When IRB Analysts request clarifications or revisions during the pre-review or review of a submission, they will officially document that through a “Clarification Request” action in CATS IRB. Your response to any such requests must also be documented through the system. Your IRB Analyst will clearly communicate with you the clarifications or revisions needed and who is requesting the information (IRB Analyst, IRB Subcommittee, IRB Committee); they will also clearly communicate a deadline for response to the request. You will receive automatic reminders from CATS IRB every 15 days until you officially submit your response through the system.
The Clarification Request function is the official communication from the IRB; you may, for example, talk to your IRB Analyst over the phone or through email about questions and changes, but it is through Clarification Requests and your responses in CATS IRB that the IRB documents the movement of your materials through the review process.
You can view the state of your study in CATS IRB in the study workspace. The flowchart moves in real time so you can track its progress.
If a study is determined exempt, the IRB will generally review the Study Submission Form, the study protocol, and data collection instruments. They will not, for example, review your consent forms or recruitment materials, even if these are provided for review.
If a study is reviewed at the expedited or committee level, the IRB will review the Study Submission Form, the study protocol, consent forms, recruitment materials, data collection instruments, and other supporting materials.
Where applicable, the IRB will review external (and internal, if such documentation exists) grant proposals/applications for congruency with the study protocol. Furthermore, the IRB will not approve a submission or make an exempt determination until all study team members have completed the required training in CITI.
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 and clarifications needed, the complexity of your study, the study population, the level of review, and whether you need other internal approvals before the IRB can review and approve the submission or make a determination.
For studies determined to be exempt, the time from initial submission to an initial determination is approximately 10-15 days.
For studies reviewed at the expedited level, the turnaround time is approximately 20-25 days.
For studies reviewed at the committee level, the turnaround time can vary greatly but is approximately 25-35 days. The timelines provided above include both the IRB review time as well as research team response time. For more detailed information on month by month IRB review timelines, please visit the IRB Metrics section within CATS IRB, located in the Help Center.
Meetings will call to order at 11:30 a.m. on the following dates in 2018:
- January 18
- February 22
- March 22
- April 26
- May 10
- May 24
- June 28
- July 26
- August 23
- September 13
- September 27
- October 25
- November 15
- December 13
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.