November 2009 Announcements

• Welcome To Our New IRB Analysts
• FDA Authorizes Emergency Use of IV Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings
• New FDA Guidance on Investigator Responsibilities
• Change in Consent Form Template
• Help is available with the IRB Application Forms
• Help is available with Research Compliance Issues
• HRPP/IRB, Phone numbers & address
• New IRB Protocol Submission Times
• Weekly Submission Drop-Off at Main Campus
• IRB Delivery Now Available Through Campus Mail
• CITI Education Requirements
• Research Pharmacy Agreements Required

New IRB Staff Members

The HRPP would like to welcome our two new IRB staff members, Stephanie Casso and Jennifer Thomas.  Stephanie and Jennifer have just recently started with the IRB administration and are here to help you with your IRB needs.  Stephanie and Jennifer will be participating in the preliminary review of your research and the return of your Notice of Committee Determinations.  Stephanie and Jennifer's contact numbers are listed below. 

FDA Authorizes Emergency Use of IV Peramivir for 2009 H1N1 Influenza

The U.S. Food and Drug Administration announced that in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to the hospital.  If you have questions about this release you may contact the HRPP office.

New FDA Guidance on Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects

The FDA has released new Guidance for Industry that is intended to clarify for investigators and sponsors the FDA's expectations concerning the investigator's responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or third parties and (2) to protect the rights, safety, and welfare of study subjects. This guidance should be read by all principal investigators and all others involved in the conduct of clinical trials. The document can be found at the following link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf

Change in Consent Form Template

Please be sure to check the IRB Forms page on our website for the latest version of the consent template. HRPP.  Mandatory AAHRPP language has been added to the "Whom Do I Call if I Have Questions" section and language was removed from the tissue consent addendum. The updated version of the consent form document will be required on any initial application, continuing review or modification request submitted for review.  Remember to always check the website prior to completion of forms in order to be sure that you are using the latest version of a form.

Help is available with the IRB Application Forms

Please let us help you with your research applications before you make all the required (26) copies. Many of you may already know the IRB is now providing preliminary review of research projects to help identify problem areas before they are presented to the committee for review. We are glad to be able to assist you with your submission.  This screening process is designed to reduce the number of revisions required before research can be approved. Please schedule an appointment with one of the IRB analysts or the IRB administrator if you would like your research application screened prior to making copies and submitting them to the IRB. Due to the volume of requests received by the IRB for assistance, please schedule your appointments in advance of deadline dates. (see phone numbers below)

Help is available with Research Compliance Issues

HRPP is offering informal quality assurance review for any research department that would like guidance on Good Clinical Practice procedures and research compliance issues. The informal quality assurance review is for education, support, and guidance purposes only.  If you have questions or concerns regarding the regulatory management of your studies please call one of the HRPP Quality Assurance Coordinators. (see phone numbers below)

The HRPP/IRB Directory of Phone Numbers

The HRPP/IRB Address

The HRPP/IRB has moved to Chevyland. Our new physical and mailing address is:

Louisiana State University Health Sciences Center-Shreveport
Institutional Review Board
2627 Linwood Avenue, Building 2
Shreveport, LA 71103

IRB Protocol Submission Hours

The IRB will be accepting submissions from 8:00 a.m. to 4:00 p.m., Monday through Friday. We will no longer close from 11:00 to 2:00 each day. However, we will stop accepting admissions at 12:00 noon on the days that IRB meetings are held. The meetings are held on the first Wednesday and the second Monday of each month. Please refer to the IRB Calendars for more specific meeting dates.

Weekly Submission Drop-off at Main Campus

The IRB will be on the main LSUHSC-S campus in room 2-414 of the medical school (next to stairwell) each Thursday from 1:00 - 2:00 p.m. to collect your IRB submissions. Log sheets will be posted on our website on the forms page so that you will be able to fill out the log sheets ahead of time. If you have questions, concerns, or need assistance with your submissions, we ask that you please come visit us at our new location.

Collaborative Institutional Training Initiative (CITI)

CITI completion reports are now required for all IRB submissions. The IRB is unable to process any research applications for initial review, continuing review, or modification requests if CITI research education has not been completed by all research personnel involved in the conduct of the study. Prior education courses completed through the Compliance Office are no longer valid. Follow this link to CITI: http://www.citiprogram.org/default.asp

Mandatory Use of Research Pharmacy

All outpatient study drugs are required to be stored and dispensed by the Research Pharmacy. This policy became effective September 1, 2009.  A Research Pharmacy Service Agreement will need to be in place for each study that involves the use of study drugs. Please contact Randy McKnight, RPh, Pharmacist-in-Charge, 318.813.1197 for more information.

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Please contact Aliese Seawright at jseawr@lsuhsc.edu or 318.675.7811; or Donna Singleton at Dsingl1@lsuhsc.edu or 318.675.5925 if you need additional information regarding any of these announcements.

Archived Announcements:
April 2009
May 2009
July 2009
August 2009
September 2009
October 2009