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.
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 assist those, who have submitted an IRB application and have received a notification indicating "Modifications Required."
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 (go to page 4 of the guide).
If the study was approved after July 2020, a regular Amendment may be submitted.
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
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 for Developmental Approval
Developmental Approval may be requested by investigators, who may be working with the Office of Sponsored Programs (OSP) to apply for funding. This status allows investigators to continue to apply for funding, while they work on fully developing their project. Developmental Approval is not final approval. All instruments and consent forms must be submitted before IRB can review the application. When investigators are ready to submit for full IRB approval, they may email firstname.lastname@example.org to request the application be returned for modifications and IRB review.
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. Stephen Beck (Associate Vice President, Office of Research & Economic Development)
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@example.com.
Special Requests or Letters
Email firstname.lastname@example.org for special requests or letters.