NEW!!! GUIDANCE AND FREQUENTLY ASKED QUESTIONS RELATING TO HUMAN SUBJECTS RESEARCH DURING THE COVID-19 OUTBREAK

 

HUMAN SUBJECTS RESEARCH PROTECTION PROGRAM & THE INSTITUTIONAL REVIEW BOARD

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LSUHSC-NO’s Human Subjects Research Protection Program (HRPP) and Institutional Review Board (IRB) are responsible for reviewing all research activities or investigations involving human beings, with the purpose of protecting the rights and welfare of individuals participating in such research. It is the policy of LSUHSC-NO that all activities involving human beings and/or information or specimens collected from human beings must be presented to the HRPP for a determination as to whether:

• the activity is human subjects research (HSR),
   
• the HSR activity can be given Exempt status under federal regulations, or
   
• the HSR activity must have IRB review, approval, and continued oversight.

 

IRB Policies and Procedures

• HRPP IRB Policies and Procedures 
   
• 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.
   
• 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.

 

HRPP & Emergency Readiness

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

 

Useful Reference Links

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

 

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