What materials are needed with the initial submission?
All materials that are relevant to the proposed project are required. A sample list is provided below and should not be considered exhaustive; each study is unique.
- The completed and certified initial submission in Cayuse IRB
- Any consent and/or assent documents
- Any scripts that will be used to obtain verbal consent and/or assent
- Any scripts that will be used to solicit human participants
- All screening documents that will be used
- Any other materials that will allow the reviewer to make an informed decision regarding the potential risks and benefits associated with the proposed study
What happens to my application once it is submitted to the IRB?
After the IRB office receives your application, it is initially screened to determine if there are any documents or forms missing.
If all materials are included in the submission, then the protocol is assigned for review by an IRB Analyst. Each reviewer has seven working days in which to complete the review or to inform the IRB Analyst that the reviewer cannot complete the assignment in a timely fashion.
During this process, the reviewer evaluates the application and all accompanying materials to assess the risks and benefits in the proposal. After this is complete, the reviewer determines the level of risk and assigns the application to either 1) exempt 2) expedited-minimal risk or 3) full board-more than minimal risk.
If the protocol is considered exempt or to pose minimal risk, the application is handled by the IRB Analyst in conjunction with the reviewer to determine the steps needed for final approval.
If the protocol is considered to pose more than minimal risk, the application is assigned to the full board for review. At that time, the Board will review the application and supporting materials to determine if the risks are sufficiently mitigated to allow the study to proceed. The IRB Analyst and the members of the Board will determine the steps needed for final approval.
After all steps are met satisfactorily, the IRB Analyst will draft a letter of approval of the project. The letter will contain information regarding the type of review and the beginning and ending date of the approval. If there are special circumstances that must be abided by, the letter will contain that information (e.g., the procedure may only be used on two participants and a report provided to the IRB Chair).
What happens if there are problems with my application?
If at any point problems with the application are noted, the IRB Coordinator or a member of the Board will contact you to help resolve the problems. If you are submitting through Cayuse IRB, you may receive an email notifying you that revisions are needed.
Are all applications reviewed the same way?
Yes and no.
Yes, in that initially all applications are screened for completeness.
No, in that the type of review that is used is determined by the IRB. The determination depends in part on the amount of perceived risk to the participants. There are three categories of review (see 45 CFR 46.110):
- Exempt – To qualify as an exempt study, the research must fall within one of the specific governmental categories AND satisfy the other regulatory and Montclair State University institutional exceptions. The Montclair State University IRB will make the exemption determination, not the principal investigator. Any study that the University IRB believes is not exempt must undergo either expedited or full review.
- Expedited – If the research activities (1) present no more than minimal risk to human subjects and (2) involve only procedures listed in one or more of the government categories, then the research may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
- Full – Research activities that involve more than minimal risk must be reviewed at a convened IRB meeting.
How long does the process take?
The IRB has set goals for turnaround time from the time of receipt of the application to the time of approval. The time it takes for a complete review of a new application, regardless of type of review, depends in part on completeness of the application, the time spent by the investigator in responding to the concerns of the IRB, and the need for additional review.
- Exempt – Goal: two to three weeks
- Expedited – Goal: four to six weeks
- Full – Goal: six to eight weeks
When can I begin my research project?
You can begin your study only after you have received your approval letter via email. You will not receive stamped documents.
For how long is my approval valid?
Approval is generally valid for one year; however, this is not a guarantee. The length of approval is determined by the IRB and depends in part on the amount of risk perceived to be in the study. Length of approval can be time-limited, or it may be limited to a prescribed number of procedures. The letter of approval will indicate the length of the approval period.