Tips for Using IRBManager

Below are some tips for using IRBManager and some small procedural changes that have occurred in the Office of Research Compliance and Integrity (ORCI) as a result of the conversion to IRBManager.

General

• “xForm” refers to any form submitted to ORCI (e.g., new protocol submission, amendment, etc.).
• Click “Start xForm” to see a list of forms available. Note that study-specific forms (e.g., Continuing Reviews, Amendments, Closures, and Adverse Event forms) are only available when clicking the “Start xForm” from within an active study page. (Make sure you are on the general study information page, and not a specific event within that study.)
• The Collaborator button within a form gives individuals access to the FORM only, it does not add them as study personnel to a protocol. (The latter is done through the questions on the form.)
• If a PI gives collaborators “submit” rights, when the collaborator presses submit, the xForm will get routed to the PI. Only the PI can advance the Form to the Authorizing Official/ORCI.
• Names of Authorizing Officials are built into the system; you do not need to add AOs as collaborators on your protocol. When you press submit, the form will get routed to the AO.
• Whenever you open a new form, it adds that form to your list of “unsubmitted” forms. The form will remain there until you submit it or delete it. (So if you see several unrecognized forms in your unsubmitted xForms list, it is likely you previously opened a new form without realizing it.)
• To see all the questions on a form, click on the print icon to the left of the form name on the “Start xForm” page. (Note this displays everything in the form—questions, as well as conditioned information that may be shown when a particular response is entered to a conditioned question.)
• Expiration dates for your training certificates can be tracked using the "My Expirations" link in the user Settings menu (available from the Dashboard). IRBManager will send automatic expiration reminders 30 days prior to the certificate expiring.

Human Subjects Research (Institutional Review Board [IRB])

• The exempt and expedited/full review submission forms have been combined into a single "IRB New Protocol Submission Form.” Based upon the answers provide in the form, you will be prompted to answer either the exempt- or expedited/full board-related questions.
• Training certificates can either be attached to the “IRB New Protocol Submission Form” or sent to ORCI via the “Training Certificate Upload Form.”

Conflict of Interests (COI)

• The PDF version of the “Conflict of Interest Disclosure and Certification Form” will eventually be discontinued. This form is now available in IRBManager.
• The new IRBManager version of this form is designed to capture potential COI issues for ALL of your university research.
• IRB submissions no longer require the separate "Conflict of Interest Disclosure and Certification Form" from all researchers named on the protocol. Instead, the PI is prompted to answer a COI question on behalf of the research team.
• All personnel listed on an Office of Sponsored Programs (OSP) application are required to submit a Conflict of Interest Disclosure and Certification Form through ORCI prior to application submission. This form must be updated at least annually for the length of the award, even if no new COIs arise. If any new real or perceived COIs arise during the course of the project, they must be reported to ORCI and OSP as soon as they become apparent.

Animal Research (IACUC)

• The Three-Year Renewal Application Form has been discontinued. If you are submitting a renewal, please use the “IACUC New Protocol Submission Form.”
• Each new protocol will be assigned a new protocol number; legacy protocol numbers for renewal applications will be phased out over the next three years.