[Ace-recruitment] IBIS Network - Week In Review - 7_14_2023

Chappell, Chad cchappel at med.unc.edu
Fri Jul 14 17:54:19 EDT 2023


IBIS Week In Review
7/14/2023

IBIS DS IBR Approval
A new DS modification has been approved and the following has been sent to each site:
1.       DS/control verbal consent - updated with additional information about the purpose of the study and to reflect LEAP questionnaires as part of the verbal consent process
2.       DS informed consent - updated to include texting as well as email - IRB now requiring participants to mark their initials on the consent indicating permission for text and email - please make sure this is filled out
3.       LEAP Child Exposure form and LEAP Adult proficiency form - these forms have been added to the screening call and should be completed along with the TSI and SCQ/M-CHAT.  They must be completed on all subjects, even if they only speak one language.
4.       Control TSI - updated to reflect current exclusion criteria and the addition of the LEAP measures to the screening call.
5.       DS TSI - updated to reflect current exclusion criteria and the addition of the LEAP measures to the screening call.
6.       FU TSI DS Infant and control - updated to reflect current exclusion criteria
7.       The WU PI has officially been changed to Natasha Marrus so all documents moving forward will list her as the PI

  1.  Local approval doc
9.       WU partial and full HIPAA waivers are attached.
10.   NEW intervention history is now approved.  This should be used with Infant DS subjects in place of the BSRC form.  We will also be switching to this form for EP, but that still needs to be IRB approved.  Start using this form for Infant DS immediately.
11.   Protocol has been updated and uploaded to LORIS

IBIS Executive Committee
                   New Project approved:  Early white matter microstructure development in infants with Down Syndrome, first look
                                   Investigators: Martin Styner, Omar Azrak, Dea Garic, Mark Shen, Aleeshah Nasir.

IBIS SA/ADOL
                   Sa Enrichment cohort was expanded to include HL- subjects
                   Timepoint label in LORSI will be:  V-ADOL


            IBIS EP Proband Med Records

                                Decision/clarification:

                                                We will not collect medical records from probands other than their cognitive/IQ score.

                                                Supporting documents for this effort has been sent to the IBIS Coordinators.

                                                                Will be discussed on next Coordinator call.





Have a wonderful weekend everyone!!!



 Chad


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