What is the procedure for getting IRB approval at CSU?
After a primary investigator completes the proposal application and submits it, along with applicable consent forms and letters of permission, and other required attachments, the IRB administrative coordinator will process the submission and assign it to the designated staff reviewer(s). A determination will be made at that time as to which type of review (Exempt, Expedited, Regular) is most appropriate for the submitted study. Please note that only the IRB staff have the authority to ascertain which level of review will be necessary for your particular proposal. The assigned reviewer(s) will respond with a preliminary/final decision within 10 business days of their receipt of the CAYUSE submission. If it is determined by the preliminary reviewer(s) that a regular (Full Board) review is indicated, the submission will be placed on the schedule for the next regularly scheduled (monthly) meeting. The results of the convened meeting to review the proposed study will be communicated by the primary reviewer to the study investigators via the CAYUSE reply system.
What is the process to decide whether or not research has to undergo full-board (regular) review?
Research that is classified by the reviewers as involving protected populations as participants or includes activities that are deemed to be greater than minimal risk will be scheduled for a full board (regular) review. During the academic year, these full board review meetings are scheduled monthly and the original submission must be received two weeks prior to the regularly scheduled full board review for it to be included on the docket.
How long will it take for my research protocol to receive approval?
Reviewers are permitted 10 working days to conduct their review and respond to the investigator(s) via the CAYUSE system. Any required resubmissions due to a reviewer request for additional information, documentation, or revision of the originally submitted application will also provide the reviewer with 10 business days from receipt of the revised submission to conduct the subsequent review and respond to the investigator(s). Submissions that require Full Board Review or Full Board Re-Review will be scheduled for the monthly meetings pending the date of receipt of the original or revised CAYUSE application. Please plan ahead!!
Who do I contact if I have any questions about submitting research?
Questions about anything related to institutional review can be directed to Mary Jane Karpinski, the Institutional Review Board Coordinator, at the Sponsored Programs and Research Services (216) 687-3630. Board members can answer questions as well.
Where is the Institutional Review Board located?
The IRB is administered through the Sponsored Programs and Research Services located in Parker Hannifin Hall, 2258 Euclid Avenue. The Board members are spread throughout the campus and beyond.
What are some general requirements for consent forms?
A consent form content checklist is included in the CAYUSE application.
The requirements for the consent forms are confusing. Is there a sample consent form that can be used as a guide?
At the present time, no sample consent forms are available because of implementation of the Revised Common Rule on January 21, 2019. Sample Consent forms consistent with the Revised Common Rule are being prepared and will be posted in the near future.
Is CITI certification required for all investigators/co-investigators.
CSU has a server that enables the storage and tracking of all faculty/staff/students who have taken and passed the CITI modules. There is no current CSU IRB requirement that investigators/co-investigators be CITI certified, however, it is strongly recommended that all investigators/co-investigators engage in the CITI certification process. It is available free-of-charge to all CSU faculty/staff/students that will be submitting a CAYUSE application for review of proposed human subjects research.
What are scholarly and journalistic activities, per the Revised Common Rule?
See here for a full definition. To confirm the study is not generalizable, you are still required to complete a Cayuse IRB application.