When do I need to submit an application to the IRB?

Any individual doing research with human subjects must submit an application to the IRB. Research is defined as “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. Research also includes pilot studies, feasibility studies, and other preliminary studies. Any work that will be disseminated in the public domain (ex. journal, book, conference, or website) is typically considered as contributing to generalizable knowledge. Instructors, departments, or schools that are collecting data for internal use only are not completing research and do not need IRB approval.

Where can I find the IRB application?

You may download the IRB Protocol Description Form here. Once your protocol form is complete and you have gathered all required documents you must log-in to axiom mentor to submit your application.

What information do I need to include in my application?

The IRB has completed a step-by-step guide for the application process. Please follow these steps to assist you in developing and submitting your IRB application.

What common mistakes should I avoid in my IRB application?

• Ensure that all study team members (including students) have completed the required CITI training before submitting your application.
• Ensure that the application is clear, well written, and complete. For student applications, be sure they have been reviewed by the faculty mentor for quality and completion before submission.
• Ensure that the application contains all the required documents, such as letters of support, recruitment materials, and survey questions.
• Ensure that informed consent contains all the required elements, including beginning with a short summary paragraph, and is written using language that will be understood by the target population.
• Ensure that information is consistent across all documents

Does exempt mean that I do not need to submit my study for IRB review?

No, all activities involving human subjects research must be submitted to the IRB for determination of the level of review. The PI is NOT able to make a determination of exempt on their own. Research activities that fall into one or more of the exempt categories defined by the federal regulations will be given an exempt determination, rather than IRB approval. This indicates these studies are exempt from some of the federal regulations. However, they are not exempt from institutional policies or the requirements for ethical research, including the use of informed consent.

I want to complete research as part of a classroom activity. Do I need IRB approval?

The UVU IRB defines a “class project” as any class-related project or assignment that involves human participants but is being conducted primarily for the purpose of evaluating learning (assigning a student grade) or teaching students to do research. Class projects must not involve more than minimal risk and may not enroll minors or vulnerable populations. To complete a class project you must notify the IRB by submission of a Class Project Waiver in axiom mentor. This can be completed by selecting “Classroom Project” as the Review Type during your New Protocol application. The Class Project Waiver must include a document describing the class assignment, the risks associated with the project, and how the risks will be managed including procedures for maintaining confidentiality and monitoring the students’ completion of the project. It is the instructor’s responsibility to ensure their students complete CITI training and that ethical principles are adhered to in the conduct of the class activities.

Please note: If research activities being conducted in a classroom will lead to dissemination of the work outside of the classroom setting (ex. conference presentation, thesis defense, or publication) then the work is RESEARCH and is NOT considered a class project. This work must be submitted to the IRB following the standard IRB application process.

What do I need to do if I want to modify my application, study methods, or project completion date after approval?

To make changes to your study after it has received IRB approval you must log-in to axiom mentor and submit an amendment. You can find detailed instructions here.

If your application was approved prior to Jan 2019 you will not be able to extend your project completion date. The revised Common Rule went into effect in January 2019. All previously approved projects will need to resubmit a new application under these new guidelines in order to extend their project or make substantial modifications. Projects approved before January 2019 which do not wish to extend their completion date and only need to make small modifications are grandfathered in and may continue their research under the old guidelines.

What is UVU's FWA number?

UVU's FWA number is FWA00010961.  This is used on reliance agreement documents.