Frequently Asked Questions

 

Q. How long will it take to review my application?

A. The CSUF IRB reviews Exempt and Expedited applications on a continual basis and it can take between 2-3 weeks for final approval. If the application is not complete when submitted, or if the IRB requires the applicant to make changes, the final approval will be delayed.

If an application requires Full Committee review, it will be placed on the agenda for the next CSUF IRB following submission deadlines as posted here. The CSUF IRB meets once a month and every effort will be made to finish review at the corresponding meeting. Delays in review can result from incomplete applications or instances where the Committee may require additional information in order to review and approve an application. Applicants are advised to apply well in advance of their own project deadlines.

Q. Why isn't student research automatically exempt?

A. Student, faculty or staff research may be exempt if it falls into one of the exemption categories as listed under CFR 46.101. When a student's project cannot be exempted by the CSUF IRB this is usually because the results will be published or because it involves studies of potentially sensitive nature or includes participants from a protected or vulnerable population. Vulnerable populations include but are not limited to prisoners or parolees, minors or participants with disabilities. Studies involving vulnerable populations cannot be automatically considered exempt simply because they are considered student projects.

Q: Will I be receiving a stamped consent form upon IRB approval through Cayuse?

A: No longer will your consent forms be stamped for approval. However, we will require you to include your HSR number in the footer of each consent form. Sample forms can be found hereOpens in new window .

Q. How do I make changes to an already approved protocol or consent forms?

A. You will need to send an amendment form via email to the CSUF IRB which outlines the requested changes and reason for doing so. You should also include any forms which incorporate your requested changes. Once approved, you will receive an Amended Approval Notice via email. If the changes you wish to make are so significant that a new application is required, or changes requested necessitate a different review category (i.e., exempt to full committee), you will be notified accordingly. Amendment form available here .

If you are requesting an amendment on a protocol that was approved prior to the transition to the Cayuse IRB electronic submission process, contact the Research Compliance office at 657-278-7719 or irb@fullerton.edu to create a legacy file for your protocol. This process will allow us to upload your original application through Cayuse IRB so you can continue with your amendment and/or renewal request.

Q. I took the IRB Tutorial and cannot find my Certification of Completion.

A. Unfortunately, our office does not accept the IRB Tutorial. The CSUF IRB requires investigators, co- investigators, coordinators, and key personnel involved (Including all persons who will be directly responsible for the study management, data collection, consent process, data analysis, transcription, participant recruitment, or follow up) in research to complete CITI training in the ethical use of human participants in research. CITI is a leading provider of research education training. The CSUF IRB requires re-training every five years. For CSUF CITI training options, visit the CSUF’s IRB CITI Compliance Training webpage. If you have any further questions, contact the Research Compliance office at 657-278-7719 or irb@fullerton.edu.