IRBManager

IRBManager is the electronic system for IRB application submission and management of IRB-related study records. The system provides automation to the IRB application and review process with conditioned questions, training verification with CITI, electronic signatures and routing, and email notifications. It also allows for collaboration between researchers when completing the IRB application, as well as collaboration with the IRB office during IRB review of the application. The system maintains all IRB-related records for your studies.

The IRB Application in IRBManager is all-in-one. It must be completed for an initial submission (new study) for either non-exempt or exempt research. For subsequent review, a Copy for Amendment of an initial submission (new study) will be used as a modification, personnel change, continuing review, or closure.

The benefits of the electronic application are:

Questions are conditioned to show up or hide based on the responses in the progression of the application.
It will include a full description of the current IRB-approved protocol at all times. Changes made over time will be integrated into the current protocol.
All submitted documents (consent forms, data collection materials, recruitment materials, etc.) will be contained within the application giving you easy-access to the most recent versions.

ISU-Affiliated personnel: Personnel are identified by their ISU email address. If an ISU-affiliated individual is not recognized when their email address is entered, they must log into IRBManager using their ISU credentials one time. Logging in to IRBManager one time establishes individuals as a contact in the system. After they have logged in once, you will be able to add them to the IRB application.

We strongly advise having all study personnel log into IRBManager before you complete the IRB application.

Non-ISU-Affiliated: For persons who do not have an ISU email address, the form includes the option to “Add Non-ISU Contact” in the Key Personnel section.

IRBManager automatically routes completed applications to the next step in the review process based on information provided in the form. For example, Supervising Investigators for student-led projects will automatically receive the completed application for review and electronic signature after the student’s has finished the form.

Signing the form involves entering user-name and password. Emails will notify supervising investigators or department chairs when an IRB application needs review and signature.

Basic protocol information (title, PI, dates of approval and expiration) has been imported into IRBManager for studies approved or exempted prior to March 19, 2018. Researchers will need to complete the IRB application in IRBManager, entering a full protocol description, the first time a modification or continuing review is submitted on or after March 19, 2018. The form is simplified, and does not require a full protocol description, for changes in study personnel and continuing review of studies where all data collection is complete and only data analysis remains.

I have received an email notification indicating I should take action on an IRB application. What does that mean?

IRBManager sends automated notifications to those that should take the next action on an IRB application. Some examples include:

Notifying the Supervising Investigator to review an application for which the PI is not eligible to serve as PI alone.
Notifying personnel to confirm any Significant Financial Interests related to the research.
Notifying Department Chairs when an application is ready for departmental review.
Notifying investigators when the IRB is requesting additional information or action on their IRB application.

A link to the IRB application is provided within the email for ease of accessing the form.

Do I have to re-take human subjects training?

It depends. All study personnel must have completed training on the protection of human subjects through the CITI Program in order for applications to be submitted in IRBManager. Either the Social/Behavioral Research Course or the Biomedical Research Course will suffice. You only need to re-take training if you have not already completed the appropriate CITI training course.

The IRB application shows that my CITI training is “Missing”.

CITI training records are updated in IRBManager overnight. IRBManager recognizes training in CITI that is taken by individuals who documented their affiliation with ISU and used their ISU email to set up their CITI account. If you have taken the training and your training is listed as “Missing” in the IRB application, please wait until IRBManager is updated overnight before submitting your application. If after the overnight update the training still shows as “Missing”, please contact the IRB office.

The system does not find an ISU-affiliated individual when I enter their email address. What do I do?

If you see a message indicating contact not found after entering an ISU email address, that means the individual is not established as a contact in IRBManager.

All personnel must log into IRBManager using their ISU NetID and password one time to establish themselves as a contact in the system before they can be added to IRB applications. Individuals will be automatically established as a contact after logging into the system once—there are no additional forms to complete for ISU-affiliated persons.

We strongly advise having all study personnel log into IRBManager once, if they have not done so already, before you complete the IRB application.

IRBManager

IRB Manager Information

IRBManager Account Information:

Researcher’s Guide to IRBManager:

About IRBManager

The IRB Application

Application Preview/Generating a PDF

Entering Study Personnel

Signatures and Routing

Transitioning Older (paper application) Studies into IRBManager

IRBManager Use Training