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
- HRPP IRB Policies and Procedures Guidebook Update 9/27/16
IRB LISTSERV (IRB_UPDATES-AND-ANNOUNCEMENTS): This LISTSERV will be used to update everyone involved in human subjects research of new information and/or updates to HRPP and IRB policies and procedures. All study team members must join this LISTSERV before new or re-approval IRB applications will be processed. To subscribe, click on: http://www.listserv.lsuhsc.edu/scripts/wa.exe?INDEX. Should you have difficulty subscribing, contact Lynn Arnold (firstname.lastname@example.org) to assist you in subscribing to the LISTSERV..
II. IRB Application
A. Submit one of the following IRB Application forms. 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 PETAL 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.
- IRBchoice Abbreviated Application - Utilize when the LSUHSC-NO IRB will be the RELYING IRB in the IRBchoice Network. [If the LSUHSC-NO IRB will be considered as the Lead/Primary IRB, use the appropriate standard application listed above as 1, 2 or 3.] Update 11/9/16
B. Submit both of 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.
- COI Team Member Form - required for every study.
C. Other IRB and HIPPA forms that may be required during the application process include:
- Informed Consent Form (ICF) Template (click here for instructions for completing the ICF) Update 9/27/16
- Informed Consent Guidance Tool for Unspecified Future Research NEW 9/27/16
- Non-English Speaking Subjects Short Informed Consent Form Templates: (click here for instructions for non-English speaking subjects Short-ICF)
- Waiver of Informed Consent, Waiver of HIPAA Authorization, and Waiver of Documentation of Informed Consent
- HIPAA and Research: Guidelines and Forms to document HIPAA Authorization
- Device Review Sheet - Updated 12/15/15 Use if the device is the purpose of the investigation and will be used to evaluate the safety or effectiveness in the diagnosis of disease or other conditions; or the cure mitigation, treatment, or prevention of disease; use for minimal risk or greater than minimal risk studies.
- Supplemental Application for International Research
D. Submit an IBC Application or Request for IBC Exemption Form for the research project. Click here for IBC webpage.
III. Post-approval IRB forms:
- Add or remove personnel from an approved study, submit as one packet the following forms as required to IRBoffice@lsuhsc.edu.
- Change in Personnel Form - Updated 3/01/2016 applicable IRB, HIPAA, COI, IBC training requirements must be completed.
- COI Team Member Form - required for every study.
- A revised Informed Consent Form is required when adding or removing co-investigators.
- Demographic Certification and Attestation, only where applicable [change in PI or investigators].
IRB Re-approval or Closure Forms - submit appropriate annual form at least 30 days prior to due date.
- IRB Exempt Status Report - to continue, change status or close studies given exempt status. Update 11/9/16
- IRB Re-approval or Closure Form - for minimal risk or greater than minimal risk (full board) IRB.
- Petal Re-approval or Closure Form - for Petal central IRB approved studies. NEW 11/8/16
- IRBchoice Re-approval or Closure Form - only if LSUHSC-NO IRB is the RELYING IRB. NEW 11/8/16
Adverse Event Reporting Form: Unanticipated Problem/SAE Reporting Form
- Notification of Protocol Deviations/Violations Form
IV. Training and Other Institutional Requirements
- Human Subjects Protection Training is required with a refresher course every three years.
- NIH-IRB Self-Tutorial on Human Subjects Protection
- KDS Training - For complete listing of training requirements, go to the ORS Training Required for Research . Also listed are self-study courses for individuals who do not have LSUHSC server access or cannot provide documentation of equivalent training from another institution.
- Institutional Biosafety Committee (IBC) approval or exemption is required for each research project.
V. LSUHSC-NO Human Subjects Protection Program – Emergency Readiness
When Conducting Research at Ochsner Health System Facilities
When Conducting Research at Children’s Hospital
Useful Reference Links
- The Belmont Report
- Code of Federal Regulations
- Food And Drug Administration (FDA)
- Office of Human Research Protections (OHRP)