LSUHSC

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LOUISIANA STATE UNIVERSITY                                               Campus Correspondence
HEALTH SCIENCES CENTER at Shreveport
Office for Sponsored Programs and Tech Transfer
Institutional Review Board Correspondence

   Date:  May 28, 2008          

   From:  Jill Rush-Kolodzey, M.D., DrPH  
                       
   To:  Investigators and Study Coordinators          

   Re:   May 28, 2008 IRB Updates
           
Each year the IRB reviews their Standard Operating Procedures (SOP) along with the Institutional Review Board (IRB) forms by which research is conducted at this University.  In light of new issues, concerns, and regulations by the  Federal agencies that have oversight responsibility of the IRB, specifically the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA) it is necessary to provide you with updates to these documents. 

In addition to the above, LSUHSC-Shreveport has recently made the decision to apply for certification by the Association of Accreditation of Human Research Protection Programs (AAHRPP).  This entails the creation and development of a Human Research Protection Program (HRPP).  Therefore, over the next coming months you will be receiving a series of updates as to required revisions necessary to meet not only the regulations but also the elements of AAHRPP accreditation. 

As of this update, current referenced changes are noted in the email attachment which accompanies this memo.  Please refer to this attachment and implement all required changes.  Additionally, I am requesting that all Principal Investigators sign this memo as acknowledgement of this update and return to the IRB office by June 9, 2008. 

                                                                                                                                               
                                                            Printed Name of Investigator

                                                                                                                                               
                                                            Investigator’s Signature

Attachment:  See additional Email Attachment Re:  IRB Policy Revisions 5/28/08

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Clinical Research Faculty and Staff:

Effective January, 2008, LSUHSC-S has a NEW LSUHSC-Shreveport IRB Fee Schedule and payment terms. These fees and terms have been approved by Dr. McDonald. Please ensure that this language is incorporated in all sponsored clinical trial research agreements as defined below:

Sponsored Research for the IRB Fee Schedule:

• ALL industry-sponsored protocols
  

Excluded Research from the IRB Fee Schedule:

• Protocols sponsored by Federal, State, County, Local, and public funds.
• Protocols sponsored by internally funded grants.
• Protocols approved by LSUHSC-S IRB PRIOR to the effective date of this approved IRB Fee Schedule; however, contracts/grants that are currently being negotiated with the sponsor or funding agencies are subject to conditions of this IRB Fee Schedule.
• Protocols funded by Foundations and other similar organizations that do not allow such expenses.

For a copy of the LSUHSC-S IRB Fee Schedule and payment terms, please contact the LSUHSC-S IRB Office via email at shvirb@lsuhsc.edu or come by the office.

If you have any questions you may contact the IRB Office. We will be glad to discuss these fees and language with you.

The fees are mandatory and will be applied for all new sponsor supported research projects approved after January 1, 2008.

Thank you for your assistance.