Application and Screening Process

IRB applications must be submitted through Cayuse IRB - Human Ethics, a cloud-based IRB application submission and management system which streamlines all components of the IRB process. All applications, approval records, and documents are managed through Cayuse IRB. UNI students and employees may login to Cayuse with their UNI credentials by visiting Cayuse IRB.

Supplementary Documents (Uploads to the Application)

Several questions on the application require the Investigator to upload supplementary documents.  See IRB Forms and Samples for checklists and sample documents.

• Recruitment materials for each sample and method, including scripts, flyers, letters, emails, etc.
• Consent materials for each sample and method, including scripts, forms, letters, electronic display text, etc. Depending on the sample, these may include materials for consent (for adults), assent (for minors), and/or permission (for parents or guardians).
• Data collection instruments, including interview questions, questionnaires, and tests. Qualitative interviews can be approved even if all of the questions cannot be specified in advance, as long as likely questions for each topic are provided.   All instrument documents must in word, excel or pdf format.
• Human Subjects Training documentation for the PI, other key personnel, and Faculty Advisor (if applicable). Certificates of training for each key personnel must be on file with UNI before that individual becomes involved in the project. The UNI IRB accepts documentation from any legitimate training for this purpose, including those sponsored by UNI. Other training provided online by a known training provider, or training obtained while employed at another institution may be acceptable. For those who take the CITI training, a certificate will be automatically emailed to the IRB office from the CITI program. Training options offered or recommended by UNI, such as the CITI program, are described on the IRB Training page, along with instructions on how to access them.
• The Principal Investigator and Faculty Advisor are responsible for ensuring that all individuals who help with the study are appropriately trained, whether they are key personnel or not. 
• Previous IRB documentation for the project. When applicable, copies of IRB applications and/or IRB approval letters from other institutions for the current project are required at the time of submission. See Inter-institutional Research.
• Second language materials (when applicable) are not required at the application stage, but must be provided in order for the study to be approved. This refers to recruitment materials, consent documents, data collection instruments, or any other text that will be seen or heard by the participants in a language other than English. If participants are not fluent in English, these materials must be developed in (or translated into) a language in which they are fluent, and must be made available to the IRB for review. The IRB may or may not choose to consult a speaker of that language for assistance. The IRB may also, at its discretion, require the PI to submit a certified translation. Certified translations are not typically required for minimal risk studies.
• Letters or emails documenting study site cooperation from any external research site or cooperating organization are required. At least one must be on file with the IRB before the application can be reviewed.  

Avoid Common Mistakes 

The application will not be forwarded to a reviewer until the necessary documents are available for the review to take place. The most common mistakes in submissions which delay review are:   

• Missing training certification for PI and/or Advisor
• Letter/email of cooperation from at least one research site (including schools)
• Additional consent, permission, or assent forms called for by the research design
• One or more of the data collection instruments listed in the application
• Recruitment materials do not match procedures
• Inconsistencies in procedures 

Requesting a Concept Review

It is possible, under special circumstances, to request review of a study for which some of the materials are not yet available, because the project development is scheduled to take place over a period of time. In those cases, the PI may request a “concept” review or a review of only some of the procedures, and receive approval to proceed with initial activities only. If this situation is approved by the IRB, the PI will be required to submit the materials for subsequent phases of the study as a modification request and receive approval for those components prior to implementation.  When the application is complete, it will be forwarded to the IRB Chair or other designated IRB member for initial review. 

Referrals for Full Board Review

Most studies at UNI are reviewed by one reviewer (as an exempt or expedited review). However, when the IRB Chair, IRB Administrator, and/or designated reviewer receives the protocol, they make an assessment as to whether the study requires full board review. Studies that require full board review are typically those that are deemed to involve more than minimal risk, that do not meet the regulatory criteria for expedited or exempt review, and/or involve sensitive issues that the primary reviewer would like to have considered by the full board. If the study is referred for full committee review, the PI is notified, the application is forwarded to all IRB members, and the protocol is scheduled for review at an upcoming scheduled IRB meeting.