HRPP Institutional Review Board (IRB)
LSUHSC-NO’s Human Research Protection Program and Institutional Review Board (IRB) are responsible for reviewing all research projects involving the use of human subjects, with the purpose of protecting the rights and welfare of individuals participating in those projects. It is the policy of LSUHSC-NO that all projects involving human beings and/or information or tissue collected from human beings must be presented to the IRB for a determination as to whether: 1) the project is human subjects research, 2) the human subjects research project can be given Exempt status under the Federal regulations, or 3) the human subjects research project must have IRB review, approval, and continued oversight.
I. IRB Policies and Procedures
II. IRB Application
A. Submit one of the three versions of the IRB Application form. Click on How to Submit for instuctions on how to start the application process and for clarification for which version of the following IRB Application is appropriate for your research.
- Exempt Research Application - The determination of exempt status can only be made by the IRB; therefore, the researcher must apply for exemption from IRB approval and oversight. If the exemption is granted, the PI must still submit an annual status report.
- Minimal Risk (Expedited) Research Application - The researcher must demonstrate in the application how the proposed activities fall into one or more of the categories eligible for expedited review. Studies deemed appropriate for Expedited Review will be considered by the Chair and/or designee.
- Greater than Minimal Risk (Full Board Review) Research Application - Greater than minimal risk as defined in 45CFR46 and 21CFR50. These applications require review by the full committee at a convened meeting.
- LSUHSC-NO IRB PETAL Abbreviated Application - To enroll subjects in a CIRB-approved protocol, PI must submit a request to the Institution. In addition, the PI must submit the approved CIRB informed consent form (ICF) modified for local site use and the LSUHSC-NO HIPAA Authorization document. All study related documents must be made available to the LSUHSC-NO IRB through the PETAL Clinical Coordinating Center website or supplied to the LSUHSC-NO IRB as electronic versions of the documents.
- IRBShare Abbreviated Application - Utilize when the LSUHSC-NO IRB will be the Shared IRB. If the LSUHSC-NO IRB will be considered as the Lead/Primary IRB, use the appropriate standard application listed as 1, 2 or 3.
B. Submit the following required forms with the IRB application:
- Demographic Form - For use during the approval process only. Once a study is approved, use post-approval Change in Personnel Form.
- Conflict of Interest Attestation - This form must be completed by all study team members.
C. Other IRB forms that may be required during the application process include:
- Waiver of Informed Consent, Waiver of HIPAA Authorization, and Waiver of Documentation of Informed Consent
- Consent Form Template
- Non-English Speaking Subjects Short Form Instructions
- Supplemental Application for International Research
D. Obtain an IBC approval or exemption for the research project. Click here for IBC webpage.
III. Post-approval IRB forms:
- To add or remove personnel from an approved study. SUBMIT all required forms together.
- IRB Re-Approval or Closure Form
- Adverse Event Reporting Form: Unanticipated Problem/SAE Reporting Form
- Notification of Protocol Deviations/Violations Form
IV. Training and Other Institutional Requirements
- Institutional Biosafety Committee (IBC) approval or exemption is required for each research project.
- Human Subjects Protection Training is required with a refresher course every three years.
V. LSUHSC-NO Human Subjects Protection Program – Emergency Readiness
Useful Reference Links
- The Belmont Report
- Code of Federal Regulations
- Food And Drug Administration (FDA)
- Office of Human Research Protections (OHRP)
- OHRP Index for Policy and Guidance