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Forms and Review Timeline

The study can begin once the primary investigator receives approval from the Institutional Review Board.

Timelines

The type of IRB review requested determines the length of time for the approval process.

  • Exempt Review: the IRB member reviewing your request will review your request within two weeks upon receiving your completed IRB Protocol Request.
  • Expedited Review: the approval process may be longer since multiple members of the IRB must review your request before approving your request.
  • Full Review: the IRB typically convenes as an entire group regularly during the fall semester, spring semester, and once during the summer.

The current schedule for full board reviews is as follows:

  • Deadline for materials to be submitted to the IRB: 9/7/2022 Reviewed on: 9/14/2022 
  • Deadline for materials to be submitted to the IRB: 10/5/2022 Reviewed on: 10/12/2022 
  • Deadline for materials to be submitted to the IRB: 11/2/2022 Reviewed on: 11/9/2022 
  • Deadline for materials to be submitted to the IRB: 11/30/2022 Reviewed on: 12/7/2022 
  • Deadline for materials to be submitted to the IRB: 2/1/2023 Reviewed on: 2/8/2023 
  • Deadline for materials to be submitted to the IRB: 2/22/2023 Reviewed on: 3/8/2023 
  • Deadline for materials to be submitted to the IRB: 3/29/2023 Reviewed on: 4/12/2023 
  • Deadline for materials to be submitted to the IRB: 4/26/2023 Reviewed on: 5/3/2023 
  • Deadline for materials to be submitted to the IRB: 6/21/2023 Reviewed on: 6/28/2023 

Forms

All submissions to the IRB must include the following documents:

Proof of Human Subjects Training (valid for only 3 years). Please follow this link for instructions to complete the required ethical training that all individuals involved in research must complete. At the end of the training, you will be given a certificate to include in your IRB application.

IRB Research Protocol Review Application Form. This document is complete when every item is addressed. No questions can be left blank.


Consent/Assent Forms. Please use the form templates provided. Make sure that the consent/assent form addresses these issues:

  • Address all aspects of the consent/assent as outlined in the template.
  • Use clear language that is age appropriate and avoids jargon.
  • Describe potential risks and resources to address the risk
  • Describe potential benefits. If you are not providing a benefit you can state that the research will not directly benefit participants.
  • Make sure to briefly describe what the participants will have to do in the study

Consent forms must be completed by all adult participants over age 18. For participants under the age of 18, a parental consent form and age-appropriate child assent form is required.

Additional Required Paperwork

  • Description of the research including purpose and methodology. Please explain reasoning for your topic and methodologic choices. Describe the study in detail. Consider psychological, physical, or other risks to participants and identify resources in the event of negative outcome and how adverse event data will be collected.
  • Research Instruments. Include copies of all surveys, interview questions, recruitment flyers, questionnaires, etc.
  • Gatekeeper Letters if collecting data outside of Cabrini University. Please include documentation supporting data collection from the site where data will be collected if a site will be used other than Cabrini University. The document should include the full name and title of the individual granting approval and should clearly state that the site supports the particular study by the primary investigator.

Please note: If other institutions with their own IRB processes are involved, approval letters from the IRB at the partnering institutions that have reviewed the project will be required.

Please provide a single Word document with all the required components. Submit your protocol here by enrolling in the Institutional Review Board option on the Cabrini Portal (log-in required).