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 4/26/2018  

• IRB Protocol Review Fee Policy: It is the policy of LSUHSC-NO to charge for IRB review of industry-sponsored studies as a mechanism to support the administrative costs of such reviews.  Non LSUHSC-NO sites in federally sponsored multicenter clinical research studies for which the LSUHSC-NO IRB has agreed to provide oversight as the Single IRB of record are also charged fees to cover costs that would not otherwise be incurred. Access the current fee schedule.  Update 4/26/2018

• 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 (larnol@lsuhsc.edu) 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 instructions on how to start the application process and for clarification for which version of the following IRB Application is appropriate for your research.

1. 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.
   • Information Sheet for Exempt Research
      
2. 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.
   • Information_Sheet_Expedited_Research 
      
3. 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.
   • Information Sheet for Full Board Review
      
4. Central IRB (CIRB) Application   - Utilize when the LSUHSC-NO IRB will be the RELYING IRB for a study involved in a LSUHSC-NO acknowledged consortium or CIRB program (SmartIRB, IRBchoice, PETAL...). This application should not be used for NCI CIRB onocolgy studies. If the LSUHSC-NO IRB will be considered as the Lead/Primary IRB, use the standard application listed above as 1,2 or 3. 

B. Submit both of the following required forms with the IRB application:

• Demographic Form - Use during approval process only. AFTER study is approved, use post-approval Change in Personnel Form. Updated 12/15/2017
• COI Team Member Form - required for every study.  Updated 4/5/2018

C. Other IRB and HIPAA forms that may be required during the application process include:

• Informed Consent Form (ICF) Template (click here for instructions for completing the ICF)
• Informed Consent Guidance Tool for Unspecified Future Research     
• Non-English Speaking Subjects Short Informed Consent Form Templates: (click here for instructions for non-English speaking subjects Short-ICF)
  • English Version - use in conjuction with one of the translated versions.
  • French Version
  • Spanish Version
  • Vietnamese Version
• 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 -   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. Requirement of an IBC Application is determined by the collection or use of biological samples.  If an IBC is not required, the IRB will serve as the sole registration of the research project with the ORS. Along with the required IRB training requirements, all study personnel must be current with Bloodborne Pathogen training to receive IRB approval.   Updated 12/13/2017

   Select examples of human subject research studies that DO, or DO NOT, require an IBC application are listed below. The IRB and IBC has final decision if an IBC application will be required.  If you have any questions about applicability, please contact the IBC Office at IBCOffice@lsuhsc.edu. Instructions for submitting an IBC Application can be found on the IBC Webpage.

REQUIRES IBC APPLICATION	DO NOT REQUIRE IBC APPLICATION
Human gene transfer studies (including naked DNA or RNA, virus based vectors or genetically modified cells)	Retrospective or prospective “chart”  reviews
Studies that collect or use pathological or diagnostic specimens (e.g. cadaver, discarded teeth) by any research study personnel including the PI	Studies that may have human contact but do not collect any biological, pathological or diagnostic specimens (e.g. questionnaire, surveys, medical treatment or physical therapy comparison study)
Studies where LSUHSC research personnel, including the PI, collect, process, test (e.g., blood metabolite levels, urine pregnancy test), storage and/or shipping of human blood, bodily fluids, or tissue samples regardless of the performance site	Studies where the collection, processing, testing, and/or shipping of human blood, bodily fluids, or tissue samples are performed off campus and by hospital/clinical lab personnel who are NOT research study personnel
Vaccine studies that contain biological material with recombinant or synthetic nucleic acid molecules
Xenotransplants or xenografts
Therapeutic approaches that involve the use of biological agents

  

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.
  1. Change in Personnel Form -applicable IRB, HIPAA, COI, IBC training requirements must be completed.
  2. Application for CIRB Amendment - When an approved amendment is available for a LSUHSC acknowledged consortium or CIRB study, utilize this form when the LSUHSC-NO IRB is the RELYING IRB. This application should not be used for NCI CIRB oncology studies.
  3. COI Team Member Form - required for every study and every personnel listed on the study.
  4. A revised Informed Consent Form is required when adding or removing co-investigators.
  5. 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.
  • IRB Re-approval or Closure Form - for minimal risk or greater than minimal risk (full board) IRB. Updated 11/10/2017
  • CIRB Re-approval or Closure Form - utilize only if LSUHSC-NO IRB is the RELYING IRB.
     
• 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.
  • Refer to the Training Required to Participate in Research for guidance.
  • Collaborative Institutional Training Initiative (CITI)
    • Instructions for CITI
• 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.

 V. LSUHSC-NO Human Subjects Protection Program – Emergency Readiness

• HSPP - Emergency Readiness Plan
• Emergency Notification Letter for Subjects - Template

When Conducting Research at Ochsner Health System Facilities

• Requirements
• Joint Informed Consent (WORD) or (PDF format)
• Joint HIPAA Authorization

When Conducting Research at Children’s Hospital

• Joint Informed Consent Template (CH) 
• Joint HIPAA Authorization (CH)

Useful Reference Links

• The Belmont Report
• ClinicalTrials.gov
• Code of Federal Regulations
• Food And Drug Administration (FDA)
• Office of Human Research Protections (OHRP)

 

.

.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .