The IRB Application Process

The LSU Institutional Review Board reviews all human subjects research activities at the LSU A&M campus.  It is recommended to provide clear information regarding your project purpose, methods, risks, etc. to minimize the number of questions or revision requests by reviewers.  Follow the guides and templates on this web site and ensure consistency throughout the application and on all attachments.  

Timeline

The entire IRB process, from submission to approval, can take approximately two weeks for exempt studies, three weeks for expedited and up to two months for studies requiring full board review.  Be sure to respond to revision requests as quickly as possible to reduce the potential for delays.  

This process and the estimated time period to approval are similar for both initial applications and amendments.  Continuations can generally be processed more quickly, while Adverse Events/Unexpected Problems and Reliance Agreements can vary in processing times.

Pre-Review

Once a protocol has been submitted, it is first reviewed by the IRB administration.  The reviewer(s) may ask for clarification, modifications or additional information in comment boxes throughout the application.  Submissions typically undergo a pre-review within a few days of being submitted.  If a submission is returned for modifications, refer to the how-to guide for modifying an existing application.

The pre-review process can go through multiple reviews, depending on the nature of the project, the responsiveness of the research team and many other factors.  Thoroughly responding to comments and modification requests is essential to a quick turnaround time. 

Chair Review

After the pre-review process, the protocol is routed to the Chair for additional review and approval.  The IRB Chair reviews the project to ensure compliance with federal oversight of human subjects research protections, applicable state regulations and LSU policies.  He may approve the study, provide additional feedback on the protocol, request further clarification and modifications, or refer the study to a member of the IRB for their insight.  

The Chair may determine that a project is either exempt from federal oversight, may be approved through an expedited mechanism, or needs to be referred to the full board for discussion at the next scheduled IRB meeting.

Member/Consultant Review

The IRB consists of faculty with specialties in various fields, medical doctors, legal experts and community members.  The board also utilizes non-member consultants on an as-needed basis, who may be experts in specialized fields and can provide feedback in areas, such as data security.  At times, the Chair will request additional insight from a board member or a limited review by two or more board members, who may have expertise in a specific area and can help to determine if the protections in place sufficiently minimize or mitigate risks to participants. 

Determination

Once the protocol has been reviewed by IRB administration, the IRB Chair, and possibly other members or consultants, the project may either be approved or referred to the full board for further discussion at the next scheduled meeting.  Anyone listed as "Personnel" on an IRB protocol (not "Other Investigators") will be included on the approval correspondence or the notification that it has been referred to the full board.  

If a project will be discussed at a board meeting, the PI and relevant personnel will receive an email the week before the meeting with the time, date, and Zoom link for the meeting.