All projects involving human subjects and/or information or tissue collection from human beings must be approved by the LSUHSC-NO Institutional Review Board (IRB) prior to implementation of the project. Upon receiving a “Just-in-Time” or the “Notice of Award,” the Principal Investigator should begin the IRB process. Submission of the application to the IRB office will determine whether: 1) the project is human subjects research; 2) the human subjects research project can be Exempt status under the regulations, or 3) the human subjects research project must have IRB review, approval, and continued oversight. The IRB Chairman or designee will make the final decision regarding eligibility for Exempt/Expedited Review and not the Investigator or the faculty advisor.
All research projects must be submitted for Institutional Biosafety Committee (IBC) review to allow a determination of whether all bio-safety concerns are resolved or managed, or that the project is exempt from further IBC oversight. IRB approval is contingent upon IBC review and approval.
Below are links for each application—EXEMPT, EXPEDITED, FULL-BOARD, IBC application and all necessary forms that should accompany the application. Simply click on the name of the form below to open the form.
The ORPH is available to answer questions and provide guidance with the preparation of the IRB and IBC application.
HHS Humans Subjects Regulation Decision Chart is a guide to help Investigator decided if an activity is research involving human subjects that requires IRB approval.
Please Note: Student-conducted research must be supervised and submitted by an LSUHSC-NO Faculty mentor.
Initial or post-approval research applications requiring IRB review are submitted through the Kuali Research (KR) electronic submission system. Click the first or second Kuali Icon to the right to access the system. If currently you are not a registered user in KR, please consult the document Accessing Kuali Research on the Kuali QuickGuides webpage for registration instructions. This page, along with the Kuali Support Documents page, contains additional documents with instructions for navigating KR and submitting different types of applications.
Investigators may submit research studies for initial review by the IRB using one of several protocol configurations (types); these protocols are reviewed using one of three procedures.
The procedure used for review is in part dependent on the nature of the study and the level of risk to the subject participating in that study. The risk level is compared to “minimal risk” as defined by federal regulations:
The three review procedures are:
- Administrative Review – This review is conducted by members of the IRB Office staff.
- Expedited Review Procedure – This review is applicable to minimal risk studies and is conducted by the IRB Chair or an experienced IRB member designated by the Chair. This procedure is sometimes referred to as Designated Member Review.
- Convened Meeting Review – This review is applicable to greater than minimal risk research and is conducted by the Board at a convened meeting. Research reviewed at a convened meeting sometimes is referred to as a Full Board protocol or application.
The review procedures and their applicable protocol types for initial review by the IRB are tabulated below. More information about the specific protocol types is available by clicking on the link.
|REVIEW PROCEDURE||PROTOCOL TYPE|
|Administrative Review||Not Human Subjects Research Determination
|Expedited Review||Expedited Research
Emergency Use of a Test Article
|Convened Meeting||Full Board Research
Humanitarian Use Device
Investigators are responsible for ongoing requirements in the conduct of approved research. These include obtaining prior approval from the IRB before implementing any modifications, reporting any new information that may impact on the conduct of an IRB-approved research study or the safety and welfare of the participants in that study, and complying with federal regulations that require an IRB to conduct Continuing Review of research at intervals appropriate to the degree of risk.
More information about these post-approval requirements are available by clicking on the link below: