IRB Application & Submission Guides
To help faculty and staff learn the GeauxGrants Human Subjects module, we have developed a series of Step-by-Step Guides that provide straight-forward instructions relating to many parts of the protocol preparation and submission process. The guides are in PDF format and may be downloaded for later study.
How to Submit an Initial Application
This guide is for those, who are initiating an IRB protocol for a new study that has not yet been reviewed by the IRB.
This guide will help to locate an existing record if you are the PI or are not the PI but are listed as Personnel on the protocol.
How to Modify an Existing Application
This guide will assist those, who have submitted an IRB application and have received a notification indicating "Modifications Required."
How to Copy an Existing Protocol
If a new study is similar to an existing study, or most of the information is similar, it may be useful to copy all of the information into a new protocol without having to manually enter it all again. Once copied, the information can be edited to account for any differences.
This guide is for those who have already obtained approval for a study and need to make changes to that study. Any type of change being made to a study will require an amendment, whether increasing the number of participants, expanding the subject pool, or adding follow-up questions to a survey.
If the study was approved prior to July 2020, a Transitional Amendment will need to be submitted. If the study was approved after July 2020, you will need to submit either Amendment (2020-2023 protocols) or Amendment (protocols approved 2024 and after), depending on its creation year. (Determined by the middle two digits in the protocol number. e.g., IRBAM-24-0000)
A Continuation will need to be submitted for studies that are about to reach their expiration date, if the project has been completed, or if it has been postponed or cancelled. This allows for the IRB to extend the study approval, determine if the study no longer requires continuing review, or administratively close the study.
Other Types of IRB Submissions
How to Submit an Adverse Event
This is a guide that is intended for those who have experienced "Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events." (OHRP Guidance)
How to Submit a Reliance Agreement Request
If you are interested in establishing a single IRB review (i.e., One institution's IRB will be relied upon to review multi-site or cooperative research, rather than researchers submitting IRB applications to each of their respective institutions), you may log into GeauxGrants and complete the Reliance Agreement request form (from the GG landing page, select “Human Protocol” in the left column; under “Create New,” select “Reliance Agreement”).
LSU information you will need: FWA - 00003892; IORG - IORG0000106; Signatory Official - Dr. Quinesha Morgan (Director, Research Compliance & Integrity)
LSU is a member of both IREx and SMART IRB. You may check those web pages to see if your RA institution is a member also. We will also work with institutions if they have specific requirements or forms.
For additional information, or if you have questions, email [email protected].
Special Requests or Letters
Email [email protected] for special requests or letters.