Office of Research & Sponsored Programs

IRB Manual Application and Screening

Application and Screening Process


The IRB strives to process all applications for IRB review as quickly and efficiently as possible. This is accomplished by the IRB office working with principal investigators to ensure that the applications are complete prior to being forwarded to a reviewer, by conducting as much communication as possible by email, by reviewers striving to complete their initial reviews of applications within 2 weeks of receiving all materials, and by investigators responding to reviewer comments within 1 week whenever possible. 

Application Forms

To initiate an IRB review, the PI must download and complete the appropriate IRB application from the IRB website.  There are two application forms:  1) the Application for Use of Existing Data should be used for studies that only involve review and analysis of data and records that already exist; and 2) the Standard Application should be used for all other studies, including mixed methods. Please note that forms are periodically revised and thus investigators should download a current form from the website each time they prepare an application.

Supplementary Documentation (Attachments to the Application)

Several of the questions on the application forms require the Principal Investigator (PI) to develop and attach supplementary documents. Applications missing items required to begin the review will be held at screening until those items are provided. 

Supplementary documents that are required in order to begin the review are:

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, regardless of how well known they are. 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. Please do not submit instruments simply as links to an online test or survey.  Instead please copy or download them, even if the formatting is not exactly correct, and include them with the application materials.

Training documentation for the PI, Co-Investigators, and Faculty Advisor (if applicable). Certificates of training for all other key personnel must be on file 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, which are provided online by a known training provider or training obtained while employed at another institution. 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.

“On file” means the training certificate is in the IRB office, not in faculty or departmental offices. On file also does not refer to being in the database of a training providerAlthough the CITI training program automatically notifies the IRB office when someone has completed that program, not all providers do so.

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 this 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 guidance on Cross-Institutional Projects. 

Supplementary documents that are not required in order to begin the review but must be on file in order for the study to be approved are:

Second language materials 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) the participants own first language, 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, if the reviewer is not fluent.

Letters or emails documenting cooperation from any external research site or cooperating organization are required. These may come in during the review but at least one must be on file with the IRB before the application can be approved.  These should not be confused with consent documents from individual participants.

Submission and Screening

When the application and all necessary attachments are complete, the application should be submitted by email to the IRB Administrator.  Alternatively, you may submit them to the RSP Secretary.  Do not submit them directly to the Chair or other IRB reviewers. 

It is strongly preferred that the Attachments to the application be submitted as one pdf or Word file.  If the investigator does not have the capability to combine multiple document types, they may be submitted as individual files and someone in the IRB office will compile them on the investigator's behalf.  Google forms or other online documents may not be submitted.  Any such items must be downloaded into Word or pdf files (although formatting is not critical to the review).   

The application should be emailed to the IRB Administrator by the Principal or Co-Investigator.  If the PI is a student, the email should include a copy to any co-investigators and MUST include a "cc" to the student’s faculty advisor to indicate that the Advisor and any co-investigators are aware of the submission and have approved its contents. 

After submission, each new application is given an IRB protocol number for tracking purposes. Please use this number in all correspondence with the IRB whenever possible. The applications are then screened for completeness by the IRB Office in the order in which they are received. If questions are not answered or required supplementary documents are not attached, the application will be placed in a temporary file and an email will be sent to the PI requesting those additional items. The application will not be forwarded to a reviewer until the necessary documents are available for the review to take place.

The items most commonly missing from submitted applications, thus requiring communications with the PI at the screening point, are: 

  • Training certificate for PI and/or Advisor
  • Letter/email of cooperation from at least one research site (including schools)
  • Additional consent or assent forms called for by the research design
  • One or more of the data collection instruments listed in the application
  • Recruitment materials that match procedures (e.g., verbal script)

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, s/he makes an assessment as to whether the study requires full board approval.  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 so notified, the application is forwarded to all IRB members, and the protocol is scheduled for review at the next regularly scheduled IRB meeting. 

 

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