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CSTE IRB Workgroup

Kevin Gibbs, IT Operations Manager at CSTEAmanda Masters, Director of Workforce Development at CSTEAl DemariaJennifer Lemmings, CSTEErica Runningdeer, ILJessica Arrazola, Director of Educational Strategy at CSTEJeff Engel, Senior Advisor for COVID-19 at CSTERita Altamore, EpidemiologistLesliann HelmusRachel StricofAmanda Payne, Senior Consultant at J Michael ConsultingKatie BrownAnne KjemtrupJen FiddnerJulius Tonzel, Epidemiologist at LA DOH, OPH, IDEPI +112 others
Posted by Robin Krause ·

HIPAA Waivers and ICF Waivers

Good morning Everyone, 
I was wondering if any of your document in your approval letters the specific criteria for the HIPAA Waivers and/or ICF waivers?  If you do, could you provide an example of the  language?
Thank you.

Comments & Events

Joni Koenig Joni Koenig
Hi Robin - It may be overkill, but I create a table like the attached for Initial Review Approval Letters.  Not sure if this is what you're looking for.  Also, to add a bit of context, my researcher group primarily conducts research secondary to their public health role.  Because of this, I take the opportunity to educate them in the form of IRB letters.  This also helps the IRB reviewer hit all of the aspects they may need to address.  

With more "seasoned" researchers, you would probably not need to include so much of the detail.

Joni
CDPHE IRB Initial Review Approval Memo EXAMPLE.pdf 121 KB • Download
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Robin Krause Robin Krause
Thank you, Joni.  This table is very helpful.  My IAD has retired and I am trying to get our policies in order.  I appreciate you responding so quickly.
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Lou Gonsalves Lou Gonsalves
Very helpful, thank you for sharing Joni!
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