IRB Review Timeline & Paperwork
Step 1 - Complete the NIH Training available at https://phrp.nihtraining.com/users/login.php. This is required of ALL submissions after September 1, 2017. A copy of the NIH Training Certificates for all PIs, Co-PIs and other individuals
involved in human subjects research must be included with your application materials.
Review the guidelines for type of IRB Review to request:
- for less than minimal risk and research with anonymous surveys, Exempt Review
- for greater than minimal risk and collection of biospecimens and subject-identifiable records, Expedited Review
- for greater than minimal risk and interventions involving discomfort or sensitive data, Full Review
Step 2 - Submit the completed Protocol Request Form to IRB@cabrini.edu.
All materials must be submitted via email as one PDF attachment. All protocol review request forms need to include an attached desription of the study procedures. Please see this example of the student handbook for more details. (Click here for instructions to create a single PDF.)
Research and forms must be submitted and reviewed before study is conducted.
Please also include any required supplementary information.
- IRB-Consent ‑ Word doc
- IRB-Sample-Video-Audio-Consent ‑ Word doc
- IRB-Parental-Consent ‑ Word doc
- IRB-Child-Assent-under-7 ‑ Word doc
- IRB-Child-Assent-7-13 ‑ Word doc
- IRB-Child-Assent-14-17 ‑ Word doc
Step 3 - Within seven days of submitting your request, a member of the IRB will contact you via email to confirm receipt and provide your IRB Protocol Review Number.
- For students with a faculty sponsor, the IRB member will include your faculty sponsor in the email.
- For group projects, the IRB member will include the primary investigator listed.
The type of IRB review requested determines the length of time for the approval process.
- For Exempt Reviews, the IRB member reviewing your request will review your request within several days upon receiving your completed IRB Protocol Request.
- For Expedited Review or Full Review, the approval process may be longer since multiple members of the IRB must review your request before approving your request.
The IRB meets twice a semester and once during the summer. Reviews during the summer and winter break months will be extended. The IRB may also call an unscheduled meeting if the Chair deems it necessary.
Protocols will be reviewed by the Committee and classified as follows:
You will receive notification of acceptance and will be given an IRB protocol number, on file, which will be valid one year from approval date.
- Conditionally Approved (revise and resubmit):
You must address recommended revisions to study procedures and/or forms, and then resubmit. Your study will go through review again.
Your study is rejected in its current form, but you may resubmit once drastic revisions have been made. Yourstudy can go through review again.
Step 4 - The IRB members reviewing your IRB Protocol Request Form will contact you via email when your request has been approved.
- At that point, you are free to begin to collect your data and conduct your research.
- Please take note of your IRB protocol number for future reference.
If you have not heard from the IRB member reviewing your request within seven days of receiving a notice that the IRB was reviewing your Protocol Request Form, please contact that IRB member via email for an update about your request’s status.
If student or faculty researchers do not reply back to their assigned IRB reviewer's queries within 90 days, the protocol will be filed as dead and inactive.
If student or faculty researchers are at any time interested in the status of their protocol review, they should contact their assigned IRB reviewer for feedback.
IRB Protocol Continuation & Project Amendment
Your approved IRB Protocol is valid for one year from the date when you formally receive approval from the IRB.
If you want to extend your research beyond the one-year time limit, you must complete a continuation request.
If any methods, materials, or samples included in your IRB Protocol Request change, you must submit an amendment.
The Project Amendment does not extend the one-year expiration for your IRB Protocol.