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IRB Application (DOC) - Revised September 09

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FREQUENTLY ASKED QUESTIONS

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

Q. Why isn't student research automatically exempt?

Q. Do my consent documents need to be stamped on the bottom?

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

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

 

NOTE: For further clarification please contact irb@fullerton.edu

 

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 1-3 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 at http://www.ogc.fullerton.edu/IRB/meetings.htm 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?

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. Do my consent documents need to be stamped on the bottom?

A. Yes, all consent forms including parental consent forms and child assent forms will be stamped upon approval. Researchers should use the stamped/approved version of these forms for distribution to participants in their study.



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

A. You will need to send a memo (or 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 along with stamped/approved revised forms. 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.



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

A. Unfortunately, our office does not keep individual copies of tutorial scores. If you have lost or misplaced your certification prior to submitting an application, you may have to retake the tutorial. If; however, you have previously submitted an IRB application with a copy of the completion certificate attached thereto, we may be able to provide a copy. Please keep in mind that our records are archived after three years.



 

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