5/17/13
New Education Sessions:
The HRPP has added additional educational opportunities. Currently the sessions
are live however, the power point presentations will be available online.
All sessions will be held in the conference center G-221, 12n-1pm except 6/25/13
will be 11am-12noon. Bring you lunch and dessert will be provided.
The first topic is "Investigator Responsibilities: Who's in Charge?"
Registration is not required at this time.
Future schedule:
6/25/13 The Consenting Process: Does it Ever End?
7/23/13 Writing a Protocol: The first Step
8/22/13 Initiating a Study: What Comes Next?
9/24/13 Simulated IRB Meeting: Behind Closed Doors!
10/24/13 The Auditors are Coming! Are You Prepared?
11/21/13 Reporting: After Initial Approval Your Work is Not Done!
12/11/13 Vulnerable Populations: Around us all the Time
An attendance of five (combination live and/or online) sessions/modules will be required by 12/31/13.
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4/17/2013
Education Requirements
Please remember that you are to provide verification of the Institutional
Regulatory Education requirements of HRPP and CITI to the IRB with all submissions
(Initials, Modifications to add study staff, and at Continuing Review).
The verification should be in the form of the CITI certificates that you can print from
your course history and from the certificates issued either from the Live HRPP sessions
or when you took the HRPP exam.
If you need assistance with locating these documents you may contact your
research coordinator or HRPP (Janice -jsoder@lsuhsc.edu or 813-1356).
Providing the certificates at the time of submission will help prevent a delay in the
IRB review process.
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3/22/2013
Reminder
HRPP exam, SFI Disclosure and CITI modules are to be completed prior to IRB submission.
Submissions will not be processed until all requirements are completed and the documentation
is presented to the IRB.
The CITI modules to be completed are Biomedical (or Social and Behavioral),
Good Clinical Practice (GCP, Health Information Privacy and Security (HIPS), and
Conflict of Interest (COI). When you complete each module you should print a certificate
for your own file and for the research submission/PI and Coordinator.
If you do not remember your username and/or password contact Janice in the HRPP
office.
Please do not re-register and set up another account. Having multiple accounts
or using variations of your first/last names can create a miscommunication in the
completeness of your training record. If you know that you have more than one
account contact Janice in the HRPP office to have your accounts merged.
If you have completed CITI at another institution you can change your institution and
receive credit for your existing training.
If you have any questions or concerns contact Janice @813-1356 or jsoder@lsuhsc.edu
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3/8/2013
Exciting News!
NEW: IRB Committee will meet weekly
The IRB has made some significant changes. Effective March 12, 2013 there will be one
Committee only. The Committee will meet EVERY Monday (Holidays excluded).
The IRB staff will "pre-review" the submission for completeness. When the IRB staff
and the Investigator have resolved any issues the packet will be forwarded to
the next IRB meeting for review and determination.
Submissions will not be processed until all components are present.
The IRB staff are available for your questions.
The revised 2013 IRB Calendar can be found on the IRB tab of the HRPP website.
The IRB and HRPP strive to improve processes and look forward to providing you
with improved services. We welcome your comments.
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3/8/2013
New Staff:
The IRB and HRPP have some new faces.
You may recognize Suzi Petty and Denise Shewmake from around the campus.
Both have joined the HRPP as QA/QI Coordinators.
Andrea Fowlkes and Deandra Holland have joined as IRB Analysts.
When you stop by introduce yourselves.
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2/22/13
Attention: Consent Forms have been revised.
Changes were made to the header and footer.
As always please use the most current forms.
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2/15/13
HRPP Education
The HRPP exam is still available for all those that have either not taken the exam
or did not attend a Live HRPP seminar session in 2012. This exam and CITI training
are required to initiate or continue with your research on our campus.
The exam takes 30-60 minutes and is given in room 131, Clinical Research Building.
The Study guide for the exam can be found on the HRPP website, HRPP Education Modules:
http://www.lsuhscshreveport.edu/HRPP/HRPPEducationModules.aspx
For questions or to schedule the exam contact Janice 813-1356 or jsoder@lsuhsc.edu
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1/14/2013
IRB Committee 2 Calendar
The Meeting date for IRB Committee 2 in February has been changed to 2/18/2013.
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11/20/12
Attention: Consent Forms have been revised!
The IRB is preparing for the conversion to SHIELDS, the new electronic submission system.
Many of the documents and tools you normally work with will change. We are currently working
with pilot groups in an effort to minimize any functionality issues before the entire campus "goes live"
with the system.
The consent template is one of the documents that will change. Effective immediately, all NEW studies
not yet submitted to the IRB, will need to use the new informed consent template. The new consent
template is posted on the HRPP website on the IRB forms page as: HRP-502-Template Consent.
All studies that are currently "IRB Approved" may continue to use the previous consent template.
It has been revised to include an IRB Approval Date, only. The IRB Approval Date is the date the
consent document is approved by the IRB. The IRB Study Approval Period will continue to be
recorded on the IRB correspondence that notifies you of the study's determination.
Moving forward with the "IRB Approval Date" instead of the "IRB Approval Period" on the approved
consent document will eliminate the need for re-consenting subjects when the ONLY change to the
document is due to the IRB Approval Period.
If you have any questions, please contact us by email at:shvhrpp@lsuhsc.edu
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11/20/2012
HRPP Education
Thanks to all that attended the Live sessions of the HRPP "The Regulations and How We Implement
Them at LSU Health".
For those of you that were not able to attend a live session, you will need to take the "Opt-Out"
exam before 1/1/2013 for your research project to continue.
The Study guide can be found on the HRPP Website: HRPP- Education Modules.
When you are ready to take the exam you may call 813-1356 or email jsoder@lsuhsc.edu
to make an appointment.
Remember all those engaged in human subjects research must have attended a live session or
take the opt-out exam.
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10/15/12
Reminder
Please use the most current HIPAA form (September 2012) which can be found on the HRPP
website "Forms" and on the Compliance website.
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9/24/2012
Reminder!
The Regulations and How We Implement Them at LSU Health"
The required campus wide research education for Principal investigators, sub-investigators,
coordinators and other research staff will be held 2 additional sessions:
October 24-25, 2012 and November 15-16, 2012
Live session Online registration is required:
http://mcsweb.lsuhscshreveport.edu/cto/Spring12Reg/Registration.asp
If you are unable to attend a Live session you will need to register for the Opt-out exam.
Those that have already taken the exam used the Power Point Presentations listed on the
HRPP Education Modules webpage to study and did quite well.
Exam session Online registration:
http://mcsweb.lsuhscshreveport.edu/cto/HSRDP12/Registration.asp
Please remember that it is mandatory to attend either a Live session or to take
the Opt-out exam by January 1, 2013.
You may contact Janice at jsoder@lsuhsc.edu or 51356 for questions.
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Please contact Janice Soderstrom at jsoder@lsuhsc.edu or 318.813.1356/Aliese Seawright at jseawr@lsuhsc.edu or 318.813.1363 if you need additional information regarding any of these announcements.