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.
HRPP IRB Policies and Procedures Guidebook Section 5.30 (Updated 3/25/2019)
The IRB guidebook was updated to include a research protection plan section. This section reiterates the current LSUHSC-NO institutional and federal regulation requirements regarding research data protection. All Principal Investigators must develop and implement such a plan. The LSUHSC-NO IRB Chair or designee will evaluate the proposed plans during the initial review consideration of the research and periodically throughout the study approval period.
All Studies approved after January 21, 2019 are required to fill in an ICF Cover page:
For instruction to fill-in the form and to download a copy of the template go to “Other IRB and HIPAA Forms.”
Access the LSUHSC-IRB Manager website here.
The PI should select the IRB and IBC application appropriate for their research.
FULL BOARD REVIEW (Greater Than Minimal Risk)
Requires review by the full committee at a convened meeting.
NOTE: Deadline for submission of a full board application is the last Wednesday of the month to be eligible for the next month’s meeting.
REQUIRED WITH ALL IRB APPLICATIONS
OTHER FORMS THAT MAY BE REQUIRED WITH THE IRB APPLICATION
INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)
POST APPROVAL IRB FORMS
INTERNATIONAL RESEARCH IRB