Translating Research Into School-based Practice Via Small-group, Language-focused Comprehension Intervention
Phase: NA
Conditions: Language Disorders in Children
Sponsor: MGH Institute of Health Professions

Initial Submission Approved for #2020B0252
Sent Date
From
To
Cc
10/08/2020 9:13 am
Ryan Liersemann <liersemann.1@osu.edu>
Shayne Piasta <piasta.1@osu.edu>
Naomi Schneider <schneider.572@osu.edu>
Ryan Liersemann <liersemann.1@osu.edu>
Buck-IRB | Office of Research
https://orapps.osu.edu/buck-irb/index/view-correspondence/study/46202...
2 of 4
10/31/2022, 4:15 PM

Behavioral and Social Sciences
Institutional Review Board
300 Research Administration building
1960 Kenny Road
Columbus, OH 43210-1063
orrp.osu.edu
10/08/2020
Study Number: 2020B0252
Study Title: Translating research into school-based practice via small-group, language-focused
comprehension intervention
Type of Review: Initial Submission
Review Method: Expedited
Date of IRB Approval: 10/08/2020
Date of IRB Approval Expiration: 10/08/2021
Expedited category: #5, #6, #7
Dear Shayne Piasta,
The Ohio State Behavioral and Social Sciences IRB APPROVED the above referenced research.
In addition, the following were also approved for this study:
Children
Waiver of Consent Documentation
Administrative Note:
As the university moves to a staged approach to restarting research activities, refer to Human
Subjects Guidance and FAQs. If after reviewing this information and working through your college you
have additional questions, please direct emails to research@osu.edu.
As Principal Investigator, you are responsible for ensuring that all individuals assisting in the conduct of the
study are informed of their obligations for following the IRB-approved protocol and applicable regulations,
laws, and policies, including the obligation to report any problems or potential noncompliance with the
requirements or determinations of the IRB. Changes to the research (e.g., recruitment procedures,
advertisements, enrollment numbers, etc.) or informed consent process must be approved by the IRB
before implemented, except where necessary to eliminate apparent immediate hazards to subjects.
This approval is issued under The Ohio State University's OHRP Federalwide Assurance #00006378 and is
valid until the expiration date listed above. Without further review, IRB approval will no longer be in
effect on the expiration date. To continue the study, a continuing review application must be approved
before the expiration date to avoid a lapse in IRB approval and the need to stop all research activities. A
final study report must be provided to the IRB once all research activities involving human subjects have
ended.
Records relating to the research (including signed consent forms) must be retained and available for audit
for at least 5 years after the study is closed. For more information, see university policies, Institutional Data
and Research Data.
Human research protection program policies, procedures, and guidance can be found on the ORRP website.
Buck-IRB | Office of Research
https://orapps.osu.edu/buck-irb/index/view-correspondence/study/46202...
3 of 4
10/31/2022, 4:15 PM

Daniel Strunk, PhD, Chair
Ohio State Behavioral and Social Sciences IRB
Buck-IRB | Office of Research
https://orapps.osu.edu/buck-irb/index/view-correspondence/study/46202...
4 of 4
10/31/2022, 4:15 PM

Annual Status Report Confirmed for #2020B0252
Sent Date
From
To
Cc
08/25/2022 12:10 pm
Corey Spring <spring.45@osu.edu>
Shayne Piasta <piasta.1@osu.edu>
Jill Twersky <twersky.3@osu.edu>
Buck-IRB | Office of Research
https://orapps.osu.edu/buck-irb/index/view-correspondence/study/46202...
2 of 3
10/31/2022, 4:16 PM

Office of Responsible Research
Practices
300 Research Administration building
1960 Kenny Road
Columbus, OH 43210-1063
orrp.osu.edu
08/25/2022
Study Number: 2020B0252
Study Title: Translating research into school-based practice via small-group, language-focused
comprehension intervention
Type of Review: Annual Status Report
Date of Annual Status Report Confirmation: 08/25/2022
Date of IRB Approval Expiration: 08/25/2023
Dear Shayne Piasta,
The Office of Responsible Research Practices has CONFIRMED CONTINUATION of the above referenced
research.
As Principal Investigator, you are responsible for ensuring that all individuals assisting in the conduct of the
study are informed of their obligations for following the IRB-approved protocol and applicable regulations,
laws, and policies, including the obligation to report any problems or potential noncompliance with the
requirements or determinations of the IRB. Changes to the research (e.g., recruitment procedures,
advertisements, enrollment numbers, etc.) or informed consent process must be approved by the IRB
before implemented, except where necessary to eliminate apparent immediate hazards to subjects.
This confirmation is issued under The Ohio State University's OHRP Federalwide Assurance #00006378 and
is valid until the expiration date listed above. Without further review, IRB approval will no longer be
in effect on the expiration date. To continue the study, an annual status report or continuing review
application must be approved before the expiration date to avoid a lapse in approval and the need to stop all
research activities. A final study report must be provided to the IRB once all research activities involving
human subjects have ended.
Records relating to the research (including signed consent forms) must be retained and available for audit
for at least 5 years after the study is closed. For more information, see university policies, Institutional Data
and Research Data.
Human research protection program policies, procedures, and guidance can be found on the ORRP website.
Buck-IRB | Office of Research
https://orapps.osu.edu/buck-irb/index/view-correspondence/study/46202...
3 of 3
10/31/2022, 4:16 PM

IRB Protocol Number: 
IRB Approval date: 
Version: 
Assent to Participate in Research 
Verbal Script and Research Staff Documentation 
Study Title: 
Translating research into school-based practice via small-group, language-focused 
comprehension intervention 
Investigators: Shayne Piasta, Tiffany Hogan, Mindy Bridges, Kandace Fleming 
Sponsor:  
National Institutes of Health 
Read the following to the child: 
We are working with your school on a research study. Studies are done to find better ways to help people or to 
understand things better. We want to learn how to help children to understand what they read and hear.  
If you are in this study, you will come with us to answer questions so we can learn what you know about 
reading and listening.  Some children will meet with us each week during Grade 1 to learn new things – you 
will read different books and do different activities with some other children. Some children will stay in their 
classrooms. We will meet with you again a few times when you are older to see what you have learned.  
It is okay to say “No” if you don’t want to be in the study. You won’t get in trouble. 
Do you want to be in our study? 
Completed by investigator/researcher staff 
I have explained the research to the following child participant: 
     __________________________________________________     __________________________________ 
       Printed name of child  
 
 
 
 
 
  Date and time 
The child    DID    /   DID NOT   assent (circle one). 
     __________________________________________________                 OSU   /    MGH 
    Printed name of person obtaining assent 
(circle research site) 
     __________________________________________________     __________________________________ 
       Signature of person obtaining assent 
 
 
 
 Date and time 
This form must be accompanied by an IRB approved parental permission form signed by a parent/guardian. 

IRB Protocol Number: 
IRB Approval Date: 
PARENT/CHILD CONSENT FORM    Version: 
Let’s Know!2 – Opportunity for Supplemental Language and Comprehension Intervention 
Researchers at The Ohio State University, MGH Institute of Health Professions, and University of Kansas/University of Kansas 
Medical Center have partnered with your child’s school to study the Let’s Know! intervention. This intervention provides 
supplemental early language and reading comprehension instruction to young children who may need extra support in these 
areas.  We are studying children’s language and literacy development from Grade 1 through the elementary years and whether 
Let’s Know! better prepares children for later language and reading success.  Several children in your child’s school will be 
selected to experience the Let’s Know! intervention and/or contribute data to this research study. This document provides 
information about the research study and seeks consent for you and your child to participate. 
What You and Your Child Will Do 
Participation in the research study is voluntary and open to children currently enrolled in Grade 1. Your child will continue to 
receive regular instruction as provided by their classroom teacher. If you consent to participate in the study, you will complete 
the attached survey (requiring approximately 15 min) and your child’s teacher will also complete a brief survey. You may refuse 
to answer any survey questions without penalty. If you provide consent and your child qualifies: 
•
We will screen your child’s language in the fall of Grade 1 with a small group of children or one-on-one. This will take
about 10 minutes. Children will be invited to participate in the study based on their need for extra support.
•
If your child is selected to participate, we will assess your child’s language and literacy skills in the fall and spring of
Grade 1 and once in Grade 2 and in Grade 3. These assessments will be conducted at your child’s school and will be
administered by our highly trained research staff. Total assessment time at each time point is a maximum of 2.5 hrs, and
will be conducted in multiple, short sessions. Participants will also receive four 15-minute progress monitoring
assessments in Grade 1. Assessments may be audio recorded. With your permission, we will share assessment results
with your child’s teacher/school.
•
Your child may be selected to receive Let’s Know! lessons in a small group of 3-5 children. Lessons will occur four times
a week for 22 weeks during Grade 1. These lessons will be provided by research staff in a quiet space at your child’s
school during the school day. Lessons will be videotaped so we can better understand how the program works. If your
child is not chosen to receive these lessons, your child will continue to receive regular instruction in their classroom.
•
We will obtain your child’s state Third Grade English Language Arts scores when your child is in Grade 3.  We will obtain
your child’s state student identification number to get these scores; you do not need to provide them.
If you consent for your child to participate in the research and your child is selected, you will receive a $25 incentive after your 
child completes assessments in Grade 2 and Grade 3. Your child will also receive small incentives (e.g., stickers) when they 
work with our staff.   
Risks and Benefits 
As reviewed and approved by the OSU Institutional Review Board, risks associated with participation in this research are not 
greater than those ordinarily encountered in daily life. Efforts will be made to keep your child’s study-related information 
confidential. Children may participate in small groups, such that their peers will be aware of their participation and responses 
during sessions. Identifiable data will be stored on university (OSU, MGHIHP, KU/KUMC) servers and analyzed by 
investigators at these institutions. Because this is a federally funded study, non-identifiable research data may be used or 
shared with other researchers for research purposes only. Also, information may be disclosed if required by state law and may 
be reviewed by the following (as applicable to the research): 
•
Office for Human Research Protections or other federal, state, or international regulatory agencies;
•
The Ohio State University Institutional Review Board or Office of Responsible Research Practices;
•
The sponsor supporting the study.
You may refuse or discontinue participation in the research at any time without penalty or loss of benefits to which you are 
otherwise entitled. We may share a copy of this consent form with your child’s school to show your willingness to participate 
and permission to work with your child.  

 
Confidentiality 
The NIH has issued a Certificate of Confidentiality for this study. This Certificate provides extra protection for you and your 
study information and documents. The Certificates are issued so that we cannot be required to disclose any identifiable, 
sensitive information collected about you as a part of this study in a lawsuit or legal proceeding. We are also prevented from 
releasing your study information without your consent. This is a layer of protection over and above the already existing 
protections in place for you and your information, documents, or samples.  However, these protections do not apply in some 
situations. For example, we may have to release your information if a law requires us to do so, the Agency that is funding this 
study requests the information, or if the FDA tells us to release this information. We may also use your information to conduct 
other scientific research as allowed by federal regulations.  Please talk to your study team, or contact the Office of Responsible 
Research Practices at 614-688-8641, if you have questions.  You may also visit the NIH website at 
https://grants.nih.gov/policy/humansubjects/coc.htm to learn more. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not 
include information that can identify you. At most, the website will include a summary of the results. You can search this 
website at any time. 
 
Questions and Concerns 
If you have questions or concerns about the research, you may contact the OSU Project Coordinator, [Insert Project 
Coordinator Name] (insert phone number; insert email address) or Principal Investigator, Dr. Shayne Piasta (614-688-4454; 
piasta.1@osu.edu). If you are injured as a result of participating in this study or for questions about a study-related injury, 
please contact Dr. Piasta.  For questions about your child’s rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact Ms. Sandra Meadows in the 
Office of Responsible Research Practices at 1-800-678-6251. 
 
 
 
To consent for your child to participate, please complete the next page of this form and the attached survey.  Return 
all pages of this form and the survey to your child’s teacher.  Retain an additional copy for your records. 
 
 
 

 
 
 
Signing the consent form 
I have read (or someone has read to me) this form and I am aware that I am being asked to provide permission for my child to participate 
in a research study.  I have had the opportunity to ask questions and have had them answered to my satisfaction. 
I am not giving up my legal rights by signing this form.  I will retain a copy of this form.   
Please complete items (1), (2), (3), (4), and (5) below along with the attached survey. 
 
ITEM (1) – Name of Child 
Printed name of child:                                                                                                               
 
ITEM (2) – Research Participation (check one box and complete corresponding information) 
  YES  I voluntarily agree to permit my child to participate in this research and release his/her state data via state 
student identification number. 
 
_______________________________________ 
_______________________________________ 
Printed name of person authorized to provide permission for child 
Signature of person authorized to provide permission for child 
 
_______________________________________ 
_______________________________________ 
Relationship to child 
 
 
 
 
Date and time 
 
  NO  I do not want my child to participate in this research. 
 
_______________________________________ 
_______________________________________ 
Printed name of person authorized to provide permission for child 
Signature of person authorized to provide permission for child 
_______________________________________ 
_______________________________________ 
Relationship to child 
 
 
 
 
Date and time 
 
ITEM (3) – Consent for Sharing of Lesson Observations for Educational Purposes 
In addition to providing data for the research study, segments of Let’s Know! lessons or classroom observation videos are 
sometimes used for educational purposes such as presentations, class lectures, and professional development of teachers.  
Do we have your permission to use video involving your child for these educational purposes? 
YES 
NO  
 
Initial here: _____________________________ 
 
 
ITEM (4) – Consent for Release of Data to School/District 
In addition to providing data for the research study, results from assessments may be shared with parents and/or the 
school/district.  Do we have your permission to share data obtained from your child with their school/district? 
YES 
NO  
 
Initial here: _____________________________ 
 
ITEM (5) – Authorization to Access Educational Records Related to Student Progress (FERPA Compliance) 
I, the undersigned, authorize the school/district in which my child attends elementary school to release the following education records 
and/or any information contained therein: Third Grade English Language Arts state testing results.   
 
     _______________________________________ 
_______________________________________  
       Printed name of child  
 
 
 
 
Date of Birth 
 
I understand and acknowledge that: (1) I have made the choice to release my child’s education records; and (2) that I have the ability to 
notify the project I choose to no longer participate in the study through The Ohio State University, but that any such revocation shall not 
affect disclosures made prior to the receipt of any such written revocation. 
 
     _____________________________________ 
_______________________________________  
       Signature of person authorized to provide permission for child  
Date 
 
Investigator/Research Staff – I have explained the research to the participant and his/her representative before requesting the signature(s) above. There 
are no blanks in this document.  A copy has been retained by the participant. 
______________________________________    
Printed name of person obtaining consent   
 
_____________________________________________    
________________________ 
 Signature of person obtaining consent 
                              
 
 
Date and time 

IRB Protocol Number: 
IRB Approval Date: 
PARENT/CHILD CONSENT FORM    Version: 
Let’s Know!2 – Opportunity for Supplemental Language and Comprehension Intervention 
Researchers at MGH Institute of Health Professions, The Ohio State University, and University of Kansas/University of Kansas 
Medical Center have partnered with your child’s school to study the Let’s Know! intervention. This intervention provides 
supplemental early language and reading comprehension instruction to young children who may need extra support in these 
areas.  We are studying children’s language and literacy development from Grade 1 through the elementary years and whether 
Let’s Know! better prepares children for later language and reading success.  Several children in your child’s school will be 
selected to experience the Let’s Know! intervention and/or contribute data to this research study. This document provides 
information about the research study and seeks consent for you and your child to participate. 
What You and Your Child Will Do 
Participation in the research study is voluntary and open to children currently enrolled in Grade 1. Your child will continue to 
receive regular instruction as provided by their classroom teacher. If you consent to participate in the study, you will complete 
the attached survey (requiring approximately 15 min) and your child’s teacher will also complete a brief survey. You may refuse 
to answer any survey questions without penalty. If you provide consent and your child qualifies: 
•
We will screen your child’s language in the fall of Grade 1 with a small group of children or one-on-one. This will take
about 10 minutes. Select children will be invited to participate in the study based on their need for extra support.
•
If your child is selected to participate, we will assess your child’s language and literacy skills in the fall and spring of
Grade 1 and once in Grade 2 and in Grade 3. These assessments will be conducted at your child’s school and will be
administered by our highly trained research staff. Total assessment time at each time point is a maximum of 2.5 hrs, and
will be conducted in multiple, short sessions.  Participants will also receive four 15-minute progress monitoring
assessments in Grade 1. Assessments may be audio recorded. With your permission, we will share assessment results
with your child’s teacher/school.
•
Your child may be selected to receive Let’s Know! lessons in a small group of 3-5 children. Lessons will occur four times
a week for 25 weeks during Grade 1. These lessons will be provided by research staff in a quiet space at your child’s
school during the school day. Lessons will be videotaped so we can better understand how the program works. If your
child is not chosen to receive these lessons, your child will continue to receive regular instruction in their classroom.
•
We will obtain your child’s annual school reading test scores plus state Third Grade English Language Arts scores.  If
you agree, we will obtain your child’s scores from their school; you do not need to provide them.
If you consent for your child to participate in the research and your child is selected, you will receive a $25 incentive after your 
child completes assessments in Grade 2 and Grade 3. Your child will also receive small incentives (e.g., stickers) when they 
work with our staff.   
Risks and Benefits 
As reviewed and approved by the OSU Institutional Review Board, risks associated with participation in this research are not 
greater than those ordinarily encountered in daily life. Efforts will be made to keep your child’s study-related information 
confidential. Children may participate in small groups, such that their peers will be aware of their participation and responses 
during sessions. Identifiable data will be stored on university (OSU, MGHIHP, KU/KUMC) servers and analyzed by 
investigators at these institutions. Because this is a federally funded study, non-identifiable research data may be used or 
shared with other researchers for research purposes only. Also, information may be disclosed if required by state law and may 
be reviewed by the following (as applicable to the research): 
•
Office for Human Research Protections or other federal, state, or international regulatory agencies;
•
The Ohio State University Institutional Review Board or Office of Responsible Research Practices;
•
The sponsor supporting the study.
You may refuse or discontinue participation in the research at any time without penalty or loss of benefits to which you are 
otherwise entitled.  We may share a copy of this consent form with your child’s school to show your willingness to participate 
and permission to work with your child.  

 
Confidentiality 
The NIH has issued a Certificate of Confidentiality for this study. This Certificate provides extra protection for you and your 
study information and documents. The Certificates are issued so that we cannot be required to disclose any identifiable, 
sensitive information collected about you as a part of this study in a lawsuit or legal proceeding. We are also prevented from 
releasing your study information without your consent. This is a layer of protection over and above the already existing 
protections in place for you and your information, documents, or samples.  However, these protections do not apply in some 
situations. For example, we may have to release your information if a law requires us to do so, the Agency that is funding this 
study requests the information, or if the FDA tells us to release this information. We may also use your information to conduct 
other scientific research as allowed by federal regulations.  Please talk to your study team, or contact the Office of Responsible 
Research Practices at 614-688-8641, if you have questions.  You may also visit the NIH website at 
https://grants.nih.gov/policy/humansubjects/coc.htm to learn more. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This website will not 
include information that can identify you. At most, the website will include a summary of the results. You can search this 
website at any time. 
 
Questions and Concerns 
If you have questions or concerns about the research, you may contact the MGH IHP Project Coordinator, Dr. Maura Curran 
(617-643-0884; Mcurran1@mghihp.edu) or Principal Investigator, Dr. Tiffany Hogan (617-724-1054; thogan@mghihp.edu). If 
you are injured as a result of participating in this study or for questions about a study-related injury, please contact Dr. Hogan.  
For questions about your child’s rights as a participant in this study or to discuss other study-related concerns or complaints 
with someone who is not part of the research team, you may contact Ms. Sandra Meadows in the OSU Office of Responsible 
Research Practices at 1-800-678-6251. 
 
 
 
To consent for your child to participate, please complete the next 2 pages of this form and the attached survey.  
Return all pages of this form and the survey to your child’s teacher.  Retain an additional copy for your records. 
 
 

 
Signing the consent form 
I have read (or someone has read to me) this form and I am aware that I am being asked to provide permission for my child to participate 
in a research study.  I have had the opportunity to ask questions and have had them answered to my satisfaction. 
I am not giving up my legal rights by signing this form.  I will retain a copy of this form.   
Please complete items (1), (2), (3), (4), and (5) below along with the attached survey and release authorization. 
 
ITEM (1) – Name of Child 
Printed name of child:                                                                                                               
 
ITEM (2) – Research Participation (check one box and complete corresponding information) 
  YES  I voluntarily agree to permit my child to participate in this research. 
 
_______________________________________ 
_______________________________________ 
Printed name of person authorized to provide permission for child 
Signature of person authorized to provide permission for child 
 
_______________________________________ 
_______________________________________ 
Relationship to child 
 
 
 
 
Date and time 
 
  NO  I do not want my child to participate in this research. 
 
_______________________________________ 
_______________________________________ 
Printed name of person authorized to provide permission for child 
Signature of person authorized to provide permission for child 
_______________________________________ 
_______________________________________ 
Relationship to child 
 
 
 
 
Date and time 
 
 
ITEM (3) – Consent for Sharing of Lesson Observations for Educational Purposes 
In addition to providing data for the research study, segments of Let’s Know! lessons or classroom observation videos are 
sometimes used for educational purposes such as presentations, class lectures, and professional development of teachers.  
Do we have your permission to use video involving your child for these educational purposes? 
YES 
NO  
 
Initial here: _____________________________ 
 
 
ITEM (4) – Consent for Release of Data to School/District 
In addition to providing data for the research study, results from assessments may be shared with parents and/or the 
school/district.  Do we have your permission to share data obtained from your child with their school/district? 
YES 
NO  
 
Initial here: _____________________________ 
 
ITEM (5) – Authorization to Access Educational Records Related to Student Progress (FERPA Compliance) 
I, the undersigned, authorize the school/district in which my child attends elementary school to release the following education records 
and/or any information contained therein:  Third Grade English Language Arts state testing results; literacy progress measures 
administered by the school during Grades 1, 2, and 3.   
 
     _______________________________________ 
_______________________________________  
       Printed name of child  
 
 
 
 
Date of Birth 
 
I understand and acknowledge that: (1) I have made the choice to release my child’s education records; and (2) that I have the ability to 
notify the project I choose to no longer participate in the study through The Ohio State University, but that any such revocation shall not 
affect disclosures made prior to the receipt of any such written revocation. 
 
     _____________________________________ 
_______________________________________  
       Signature of person authorized to provide permission for child  
Date 
 
Investigator/Research Staff – I have explained the research to the participant and his/her representative before requesting the signature(s) above. There 
are no blanks in this document.  A copy has been retained by the participant. 
______________________________________    
Printed name of person obtaining consent   
 
_____________________________________________    
________________________ 
 Signature of person obtaining consent 
                              
 
 
Date and time 
 
 
 
 

 
Authorization to Release Student Information 
 
 
Student’s Name: ________________________________________________________________ 
 
Grade Level: __________________________ 
Date of Birth: ________________________ 
 
School Name: __________________________________________________________________ 
 
School Address: ________________________________________________________________ 
 
Records requested for the following school years: _____________________________________ 
 
 
 
I hereby authorize __________________________________________ (school district’s name) to release the 
student record information listed below for research study purposes. I understand that only personnel who are 
working on the research project will have access to my child’s student records. Student information will not 
be given to others for any purposes, it will be de-identified, and no individual scores will be used in research 
reports. This information will allow the research personnel to better understand the cognitive and linguistic 
connections to academic progress.  
 
 
 
I understand that student records include: 
 
1. 
3rd Grade MA State English Language Arts Test Scores 
2. 
Teacher report of my child’s classroom information in 1st Grade  
3. 
School-administered literacy testing results for 1st, 2nd, and 3rd Grade 
 
______________________________________________________       ____________________ 
Signature of Parent or Guardian 
 
 
 
 
       Date 
 

Dear Educator, 
We at the MGH Institute of Health Professions, The Ohio State University, and University of Kansas are conducting 
an evaluation of Let’s Know!, a small-group, language-focused intervention for children. We are studying the effects 
of the Tier 2 intervention on the language and literacy skills of children at risk for language and comprehension 
difficulties.  The study is funded by the National Institutes of Health.  
You have been invited to complete this survey because you are an educator at a partner school involved in the 
project, and you work with one or more of children participating in our study.  By completing this survey, you will help 
us understand the characteristics of students with whom you work and their Grade 1 experiences. We will ask 
questions about your teaching background, your school/classroom, and your instructional practices. We will also ask 
for your input about particular students to help us identify those eligible for study participation.  Children’s 
parents/guardians have provided permission for this information to be collected.  The results of this research study 
will help us identify evidence-based best practices for supporting young children’s language and comprehension 
development. 
The survey should take no more than 20 minutes to complete. By completing and returning the survey, you are 
granting consent to participate in the research study and for us to use the information provided for research 
purposes.  As reviewed and approved by the OSU Institutional Review Board, risks associated with participation in 
this study are not greater than those ordinarily encountered in daily life. Your participation is voluntary. Study-related 
information will be kept confidential unless disclosure is required by state law.  Because this is a federally funded 
study, non-identifiable research data may be used by or shared with other researchers for research purposes only.  
The National Institutes of Health has issued a Certificate of Confidentiality for this study.  This Certificate provides 
extra protection for you and your study information and documents. The Certificates are issued so that we cannot be 
required to disclose any identifiable, sensitive information collected about you as a part of this study in a lawsuit or 
legal proceeding. We are also prevented from releasing your study information without your consent. This is a layer 
of protection over and above the already existing protections in place for you and your information, documents, or 
samples.  However, these protections do not apply in some situations. For example, we may have to release your 
information if a law requires us to do so, the Agency that is funding this study requests the information, or if the FDA 
tells us to release this information. We may also use your information to conduct other scientific research as allowed 
by federal regulations.  Please talk to your study team, or contact the Office of Responsible Research Practices at 
614-688-8641, if you have questions.  You may also visit the NIH website at 
https://grants.nih.gov/policy/humansubjects/coc.htm to learn more. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This 
website will not include information that can identify you. At most, the website will include a summary of the results. 
You can search this website at any time. 
If you have questions or concerns about the research, you may contact the MGH IHP Project Coordinator, Dr. 
Maura Curran (617-643-0884; Mcurran1@mghihp.edu) or Principal Investigator, Dr. Tiffany Hogan (617-724-1054; 
thogan@mghihp.edu). For questions about your rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact Ms. Sandra Meadows 
in the Office of Responsible Research Practices at 1-800-678-6251. 
Thank you for helping us in this important work! 
Sincerely, 
Dr. Maura Curran, Project Coordinator  
Dr. Tiffany Hogan, Principal Investigator