From: Cari Loeffler <no-reply@irbnet.org>
Date: Tuesday, August 6, 2024 at 9:29 AM
To: Burke, Mack <Mack_Burke@baylor.edu>
Subject: IRBNet message from Cari Loeffler

Message from Cari Loeffler:

Re: [1873950-4] Literacy, Language, and Social-Emotional Support for English Learners With and Without Disabilities in Inclusive Settings

Hi Mack,

Good morning! I heard back from our AVP and she did not recommend changing the review level. We have conducted the pre-review for this submission and included the modifications requested below. Please be sure to mark the revisions as complete in IRBNet when you are ready to resubmit the IRBNet package for review.

F-02 Vulnerable Populations Supplement:
Question 1: Please state the age range instead of the grade levels for the participants.
Question 15: Please remove the statement “(other languages may be added based on school needs) as an additional amendment would need to be submitted with translated parent permission and assent forms if additional languages are added in the future.

F-11 Form:
Description of changes:
The F-02 form states that the parent permission, consent, and assent forms will be translated into Swahili and Urdu as well, please add Swahili and Urdu to the list of languages in the following statement or remove Swahili from the response to question 15 on the F-02 form:
“Our project can provide support for all English Language Learners with and without disabilities.  Schools that have agreed to work with our project have students whose native languages are Arabic, Pashto, Farsi/Persian, and Spanish, therefore the translated parent consent forms need to omit the phrase "To participate, your child's first language must be Spanish or Spanish is primarily spoken in the home." 

Please add a description of all changes being made to existing study documents and list the study documents being added. For example:

Revised existing Minor Assent Forms (Spanish and English versions) to remove the following statement:
“In order to participate in this study, your primary language needs to be Spanish.”

Revised existing Adult Student Consent forms (English and Spanish versions) to remove the following statement:
“To participate in this study, your primary language needs to be Spanish.”

Revised existing Teacher Consent Forms (English version to remove the following statement:
“The primary language of the English learners must be Spanish.”
Removed Spanish version of the teacher consent form as all teachers are fluent in English.

Translated the following study documents into Arabic, Pashto, Urdu, Swahili (remove if not being translated), and Farsi/Persian:
Minor assent form
Adult student consent form
Parent consent forms

IRBNet Package:
Missing documents: Please attach copies of the following documents to the IRBNet package:
Track changes versions of the following revised study documents:
ENGLISH T-03 Minor Assent Form - LEER - 2.27.24.docx
SPANISH T-03 Minor Assent Form - LEER - 2.27.24 (1).docx
SPANISH T-02 Adult Student Consent Form - LEER - 02.27.24 (2).docx
ENGLISH T-02 Adult Student Consent Form - LEER - 02.27.24.docx
SPANISH T-04 Parent Permission Form - LEER - 2.27.24 (2).docx

Translated versions of the following new study documents (if documents will be translated into Swahili, otherwise ignore this comment):
SWAHILI T-03 Minor Assent Form
SWAHILI T-03 Adult Student Consent Form
SWAHILI T-03 Parent Permission Form

Protocol (both revised and clean versions)
Title page: Please update the version date on the first page and within the footer of the document

Section 3.0:
Age ranges of participants and the total enrollment numbers and any group/cohort breakdown numbers must be stated in this section.

Translation attestation form:
Add Swahili to the list of languages if documents will be translated into Swahili.

Have a great day!

Regards,
Cari Loeffler