ATTACHMENT A. Informed Consent Forms 7.26.18 CLEAN

ATTACHMENT A. Informed Consents 2.27.2019 CLEAN.pdf

Multi-Site Implementation Evaluation of Tribal Home Visiting

ATTACHMENT A. Informed Consent Forms 7.26.18 CLEAN

OMB: 0970-0521

⚠️ Notice: This form may be outdated. More recent filings and information on OMB 0970-0521 can be found here:

2020-08-14 - No material or nonsubstantive change to a currently approved collection

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Attachment A:
Informed Consent Documents

Table of Contents
CONTINUING CAREGIVER QUANTITATIVE CONSENT ........................................................................................ 1
NEW CAREGIVER QUANTITATIVE CONSENT ..................................................................................................... 6
HOME VISITOR QUANTITATIVE CONSENT ........................................................................................................11
PROFESSIONAL (NON-HOME VISITOR) QUANTITATIVE CONSENT ....................................................................15
PROGRAM IMPLEMENTATION SURVEY CONSENT FORM .................................................................................20
CAREGIVER OVER 18 QUALITATIVE CONSENT ..................................................................................................24
PROFESSIONAL OVER 18 QUALTITAVE CONSENT .............................................................................................29

An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The
OMB number for the described information collection is 0970-0521 and the expiration
date is 12/31/2021.

CONTINUING CAREGIVER QUANTITATIVE CONSENT
Study Title:
Principal Investigator:
COMIRB No:
Version Date:
Informed consent for:

Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Nancy Rumbaugh Whitesell, Ph.D.
18-0109
January 17, 2019
Version #: 3
Home visiting caregiver
Enrolled in home visiting services BEFORE the MUSE study started (before XX-XX-2019)

You and your child are being asked to be in a research study. This form provides you with information about the
study. Your home visiting program is participating in this study with other tribal home visiting programs across
the country. Someone from your home visiting program will explain this study to you and answer your questions
about it. Please read the information below and ask questions about anything you don’t understand before
deciding whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the children
and families in these programs. This study may help programs by identifying what is working well and where
services can be improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you and your child are in a tribal home visiting program.
We want to know about your experiences with home visiting. We also want to know about you and about your
child’s development.
17 tribal home visiting programs are involved in the MUSE study.
Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,606 people will
be included.
What happens if I join this study?
If you join the study, you will be asked to:
1. Take a 5-minute survey after a few of your home visits.
2. Allow your home visiting program to share some information about you with the MUSE study. For example,
they will share information about the services they provide to you. They will also share your responses to
questions they ask you about financial needs [substance use, and mental health].
We are also going to interview a few people about their experiences in home visiting. A MUSE researcher may
contact you to ask if you would be willing to be interviewed.
What happens if I agree to let my child join this study?
If you agree to let your child join the study, you will allow your home visiting program to share the following
information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire
scores.
Page 1

How long will the MUSE study last?
The MUSE study will last for about 2 years. The length of time you are in the study will depend on how long you
are enrolled in home visiting. The longest you will be in the study is 2 years.
What are the possible discomforts or risks?
The survey asks about your experiences with tribal home visiting and with your home visitor. Some of these
questions may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. The information we will collect about you from your home visiting program or on the surveys will not
be connected to your name. Your home visiting program will assign you an ID number to keep your information
private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive
information.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your tribal home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
You will not be paid for being in the study. It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you
can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive
home visiting services.

Page 2

Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise.
We will do everything we can to keep your records a secret. It cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep potentially identifying information about research subjects, like you,
private.
You have the right to request access to your personal health information from the Investigator.

Page 3

Information about you that will be seen, collected, used and disclosed in this study:




Demographic Information (age, sex, ethnicity)
Your record of participation in the home visiting program
Your answers to survey questions about your experience with home visiting

What happens to data that are collected in this study?
Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes
and cures of disease. The data collected from you during this study are important to this study and to future
research. If you join this study:






The data are given by you to the investigators for this research and so no longer belong to you.
Both the investigators and any sponsor of this research may study your data collected from you.
If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB
approval.
Any product or idea created by the researchers working on this study will not belong to you.
There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or
idea.

Certificate of Confidentiality
We have applied for a Certificate of Confidentiality to protect your privacy. This means that Dr. Whitesell or the
study team cannot be forced to give out information about you unless you request this.
However, this certificate will not prevent Dr. Whitesell or her research team from making a report in some
special cases.



If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the
appropriate authority, as per tribal and state legal codes.
If you tell us that you are going to physically hurt yourself or someone else, we have to report that to the
police.

Note: There is nothing in the survey that would require the study team to make a report to the authorities.
Survey answers are kept private and do not have names linked with them.
Who do I call if I have questions?
Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If
you have questions later, you may call Dr. Whitesell at 303-724-1456 or email her at
Nancy.Whitesell@ucdenver.edu. You may also ask your Home Visitor any questions you have or call your home
visiting program office [On paper copy: LOCAL PROGRAM CONTACT INFO]. When you call, let them know you
have a question about the MUSE research study.
You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell
with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055
[On paper copy only: or LOCAL IRB INFO].

Page 4

Caregivers complete this section
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No
Consent to use my child’s data in the MUSE study
I agree to allow my home visiting program to share my child’s birth month and year, sex, and Ages and Stages
Questionnaire scores with the MUSE study. (Check one box)
 Yes
 No
Today’s Date: ________
Staff member completes this section
Caregiver’s program ID: ____________________________________
I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is
expected during this study.
First name of staff member who explained the consent form:
Last name of staff member who explained the consent form:
Today’s Date: ________

Page 5

NEW CAREGIVER QUANTITATIVE CONSENT
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting caregiver
18 years or older
Enrolled in home visiting services AFTER the MUSE study started (after XX-XX-2019)

You and your child are being asked to be in a research study. This form provides you with information about the
study. Your home visiting program is participating in this study with other tribal home visiting programs across
the country. Someone from your home visiting program will explain this study to you and answer your questions
about it. Please read the information below and ask questions about anything you don’t understand before
deciding whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the children
and families in these programs. This study may help programs by identifying what is working well and where
services can be improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you and your child are in a tribal home visiting program.
We want to know about your experiences with your home visiting program. We also want to know about you,
your experiences as a parent, and your child’s development.
17 tribal home visiting programs are involved in the MUSE study.
Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,606 people will
be included.
What happens if I join this study?
If you join the study, you will be asked to:
1. Take up to 3 surveys about you and your experiences with your tribal home visiting program. The survey
questions ask about parenting, support you have as a parent, why you enrolled in home visiting, and other
similar topics. The surveys will take approximately 15-30 minutes to complete.
2. Take a 5-minute survey after a few of your home visits.
3. Allow your home visiting program to share some information about you with the MUSE study. For example,
they will share information about the services they provide to you. They will also share your responses to
questions they ask you about financial needs[, substance use, and mental health].
We are also going to interview a few people about their experiences in home visiting. A MUSE researcher will
contact you to ask if you would be willing to be interviewed.

Page 6

What happens if I agree to let my child join this study?
If you agree to let your child join the study, you will allow your home visiting program to share the following
information about your child with the MUSE study: birth month and year, sex, Ages and Stages Questionnaire
scores.
How long will the MUSE study last?
The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you
enroll in home visiting. The longest you will be in the study is 2 years.
What are the possible discomforts or risks?
The survey asks about your experiences with your tribal home visiting program and as a parent. Some of these
questions may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. The information we will collect about you from your home visiting program or on the surveys will not
be connected to your name. Your home visiting program will assign you an ID number to keep your information
private. Your name will not be shared with the MUSE study team. We do this to protect your sensitive
information.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your tribal home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
If you participate in the study, you will get:
 A $10 gift card for taking a survey now.
 A $15 gift card each time you take another survey. You will be asked to take up to 2 more surveys.
It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.

Page 7

If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you
can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive
home visiting services.
Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise.
We will do everything we can to keep your records a secret. It cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep the names of the research subjects, like you, private.

Page 8

You have the right to request access to your personal health information from the Investigator.
Information about you that will be seen, collected, used and disclosed in this study:




Demographic Information (age, sex, ethnicity)
Your record of participation in the home visiting program
Your answers to survey questions about you, your family, and your experience with home visiting

Page 9

You may have questions about your rights or your child’s rights as people in this study. You can call Dr. Whitesell
with questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055
[On paper copy only: or LOCAL IRB INFO].
Caregivers complete this section
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No
Consent to use my child’s data in the MUSE study
I agree to allow my home visiting program to share my child’s birth month and year, sex, and Ages and Stages
Questionnaire scores with the MUSE study. (Check one box)
 Yes
 No
Today’s Date: ________

Staff member completes this section
Caregiver’s program ID: ____________________________________
I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is
expected during this study.
First name of staff member who explained the consent form:
Last name of staff member who explained the consent form:
Today’s Date: ________

Page 10

HOME VISITOR QUANTITATIVE CONSENT
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting professional (Home visitor)

You are being asked to be in a research study. This form provides you with information about the study. Your
home visiting program is participating in this study with other tribal home visiting programs across the country. If
you have questions, you may contact a member of the MUSE study team and they will answer your questions.
Their contact information is at the end of this form. Please read the information below and ask questions about
anything you don’t understand before deciding whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in
these programs. This study may help programs by identifying what is working well and where services can be
improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you are a home visitor with your tribal home visiting
program. We want to know about your experiences with your home visiting program. We also want to know
about you and your experiences as a home visitor.
17 tribal home visiting programs are involved in the MUSE study.
Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,606 people will
be included.
What happens if I join this study?
If you join the study, you will be asked to take a survey about you and your experiences as a home visitor with
your tribal home visiting program. The survey will take approximately 70 minutes to complete. Data you provide
in your survey responses may be linked to data that your program sends to the MUSE research team about your
work activities, including the supervision you receive, but your data will never be linked to your name or other
directly identifiable information.

We are also going to interview a few home visitors about their experiences. A MUSE researcher may contact you
to ask if you would be willing to be interviewed.
How long will the MUSE study last?
The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you
complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.

Page 11

What are the possible discomforts or risks?
The survey asks about your experiences with your tribal home visiting program and as a home visitor. Some of
these questions may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. The information we will collect about you on the survey will not be connected to your name. We will
assign you an ID number to keep your information private. We do this to protect your sensitive information.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your tribal home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
You will not receive anything for being in the study. It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it
will not affect your job as a home visitor with your tribal home visiting program. If you decide to stop being in
the study later, it will not affect your job as a home visitor with your tribal home visiting program. The MUSE
study team will never tell anyone at your tribal home visiting program if you choose to be in the study or not.
The MUSE study team will never tell anyone at your tribal home visiting program if you choose to stop being in
the study later.
Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.

Page 12

We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise.
We will do everything we can to keep your records a secret. It cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep the names of the research subjects, like you, private.
You have the right to request access to your personal health information from the Investigator.
Information about you that will be seen, collected, used and disclosed in this study:




Name and Demographic Information (age, sex, ethnicity)
Your staff role with the home visiting program
Your answers to survey questions about you and your experience with the home visiting program

What happens to Data that are collected in this study?
Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes
and cures of disease. The data collected from you during this study are important to this study and to future
research. If you join this study:



The data are given by you to the investigators for this research and so no longer belong to you.
Both the investigators and any sponsor of this research may study your data collected from you.

Page 13





If data are in a form that identifies you, UCD may use them for future research only with your consent or IRB
approval.
Any product or idea created by the researchers working on this study will not belong to you.
There is no plan for you to receive any financial benefit from the creation, use or sale of such a product or
idea.

Note: There is nothing in the survey that would require the study team to make a report to the authorities.
Survey answers are kept private and do not have names linked with them.
Who do I call if I have questions?
Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. If you have questions now or later, you may
call Dr. Whitesell at 303-724-1456 or email her at Nancy.Whitesell@ucdenver.edu.
You may have questions about your rights as a person in this study. You can call Dr. Whitesell with questions.
You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [On paper copy
only: or LOCAL IRB INFO].
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will be given a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No

Page 14

PROFESSIONAL (NON HOME VISITOR) QUANTITATIVE CONSENT
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting professional (Non-Home visitor)
18 years or older

You are being asked to be in a research study. This form provides you with information about the study. Your
home visiting program is participating in this study with other tribal home visiting programs across the country. If
you have questions, you may contact a member of the MUSE study team and they will answer your questions.
Their contact information is at the end of this form. Please read the information below and ask questions about
anything you don’t understand before deciding whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in
these programs. This study may help programs by identifying what is working well and where services can be
improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you work with a tribal home visiting program. We want
to know about your experiences with your home visiting program. We also want to know about you and your
work experiences.
17 tribal home visiting programs are involved in the MUSE study.
Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,606 people will
be included.
What happens if I join this study?
If you join the study, you will be asked to take a survey about you and your experiences working with your home
visiting program. The survey will take approximately [30/45/60] minutes to complete. The MUSE research team
may link data you provide in your survey responses with data your program provides about your work activities,
but your data will never be connected to your name or other directly identifiable information.
We are also going to interview a few people about their experiences. A MUSE researcher will contact you to ask
if you would be willing to be interviewed.
How long will the MUSE study last?
The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you
complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.

Page 15

What are the possible discomforts or risks?
The survey asks about you and your experiences with your tribal home visiting program. Some of these
questions may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. The information we will collect about you on the survey will not be connected to your name. We will
assign you an ID number to keep your information private. We do this to protect your sensitive information.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your tribal home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
You will not receive anything for being in the study. It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it
will not affect your job with your tribal home visiting program. If you decide to stop being in the study later, it
will not affect your job with your tribal home visiting program. The MUSE study team will never tell anyone at
your tribal home visiting program if you choose to be in the study or not. The MUSE study team will never tell
anyone at your tribal home visiting program if you choose to stop being in the study later.
Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.

Page 16

Name and Demographic Information (age, sex, ethnicity)
Your staff role with the home visiting program
Your answers to survey questions about you and your experience with the home visiting program

Page 17

Page 18

Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will be given a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No

Page 19

PROGRAM IMPLEMENTATION SURVEY CONSENT FORM
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting program coordinator/manager and program director
18 years or older

You are being asked to be in a research study. This form provides you with information about the study. Your
home visiting program is participating in this study with other tribal home visiting programs across the country. If
you have questions, you may contact a member of the MUSE study team and they will answer your questions.
Their contact information is at the end of this form. Please read the information below and ask questions about
anything you don’t understand before deciding whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the staff in
these programs. This study may help programs by identifying what is working well and where services can be
improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you work with a tribal home visiting program. We want
to know about your experiences with your home visiting program. We also want to know about you and your
work experiences.
17 tribal home visiting programs are involved in the MUSE study.
Families receiving home visiting services and program staff will be asked to be in the study. Up to 1,606 people will
be included.
What happens if I join this study?
If you join the study, you will be asked to take a survey about your tribal home visiting program and its
operations. The survey will take approximately 15 minutes to complete.
We are also going to interview a few people about their experiences. A MUSE researcher will contact you to ask
if you would be willing to be interviewed.
How long will the MUSE study last?
The MUSE study will last for about 2 years. The length of time you are in the study will depend on when you
complete the survey and whether you participate in an interview. The longest you will be in the study is 2 years.
What are the possible discomforts or risks?
The survey asks about your tribal home visiting program operations. Some of these questions may make you feel
uncomfortable.

Page 20

There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. The information we will collect about you on the survey will not be connected to your name. We will
assign you an ID number to keep your information private. We do this to protect your sensitive information.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your tribal home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
You will not receive anything for being in the study. It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, it
will not affect your job with your tribal home visiting program. If you decide to stop being in the study later, it
will not affect your job with your tribal home visiting program. The MUSE study team will never tell anyone at
your tribal home visiting program if you choose to be in the study or not. The MUSE study team will never tell
anyone at your tribal home visiting program if you choose to stop being in the study later.
Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise. If you choose to complete this survey with another
manager at your tribal home visiting program, they will see the answers you enter together. However, they will
not have a link to access the survey on their own.
We will do everything we can to keep your records a secret. It cannot be guaranteed.

Page 21

The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep the names of the research subjects, like you, private.
You have the right to request access to your personal health information from the Investigator.
Information about you that will be seen, collected, used and disclosed in this study:




Name and Demographic Information (age, sex, ethnicity)
Your staff role with the home visiting program
Your answers to survey questions about your home visiting program

Page 22

Note: There is nothing in the survey that would require the study team to make a report to the authorities.
Survey answers are kept private and do not have names linked with them.
Who do I call if I have questions?
Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. If you have questions now or later, you may
call Dr. Whitesell at 303-724-1456 or email her at Nancy.Whitesell@ucdenver.edu.
You may have questions about your rights as a person in this study. You can call Dr. Whitesell with questions.
You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 [On paper copy
only: or LOCAL IRB INFO].
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will be given a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No

Page 23

CAREGIVER OVER 18 QUALITATIVE CONSENT
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting caregiver
18 years or older

You are being asked to be in a research study. This form provides you with information about the study. Your
home visiting program is participating in this study with other tribal home visiting programs across the country.
Someone from your home visiting program will explain this study to you and answer your questions about it.
Please read the information below and ask questions about anything you don’t understand before deciding
whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We also want to learn about the children
and families in these programs. This study may help programs by identifying what is working well and where
services can be improved. It may also help programs to better understand the families they are serving.
We are asking you to be in this research study because you and your child are in a tribal home visiting program.
We want to know about your experiences with your home visiting program. We also want to know about you,
your experiences as a parent, and your child’s development.
17 tribal home visiting programs are involved in the MUSE study.
We will ask families receiving home visiting services and program staff to be in the study. Up to 1,606 people will
be included. Within this larger MUSE study, we will also interview up to 60 people who are receiving home visiting
services.
What happens if I join this study?
You have been taking part in other parts of the MUSE study. We are now asking you to be interviewed about
your experiences with home visiting.
If you agree to be interviewed, you will:
1. Talk with someone from the MUSE team about you, your family and your experience with your home visiting
program.
2. You will be interviewed in a private office. Only you and the interviewer will be able to hear your
conversation.
3. At the time of the interview, you will be asked to let us record the interview (audio only). If you agree, we
will later transcribe the recording and remove any names you mention.
4. MUSE study team members will then share some of what they learn from these interviews in presentations,
or written reports, or articles in professional journals. Anything shared from the interviews will be written or
presented in a way that does not identify you, your family, your home visiting program or your community.

Page 24

How long will the MUSE study last?
The full MUSE study will last for about 2 years. The interview you are being asked to participate in will happen
one time and will take about one hour.
What are the possible discomforts or risks?
The interview will ask about your experiences with your home visiting program and as a parent. Some of these
questions may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. We will assign you an ID number and use this ID instead of your name on your interview transcript to
keep your information private.
There are some times when we cannot keep your information private because we want to make sure people are
safe. If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the
appropriate authority, as per tribal and state legal codes. If you tell us that you are going to physically hurt
yourself or someone else, we have to report that to the police.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
If you participate in the study, you will get:
 A $40 gift card for participating in the interview
It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you
can still receive home visiting services. If you decide to stop being in the study later, you can continue to receive
home visiting services.

Page 25

Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise.
We will do everything we can to keep your records a secret. It cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep the names of the research subjects, like you, private.

Page 26

If you consent to participate in the MUSE interview, your conversation with the MUSE study team member will
be audio-recorded on a digital recording device. We will protect the audio-recordings by:
 Using only password protected portable audio-recording devices;
 Transferring and storing audio-recordings and interview transcripts using secure data platforms
accessible to MUSE study team members only;
 De-identifying transcripts during the transcription process;
 Erasing audio-files stored on portable devices directly after successful transfer to secure data platform is
confirmed;
Audio-recordings will be erased after the transcript is verified. Interview transcripts will be kept for 5 years after
the MUSE study is complete and then erased.
You have the right to request access to your personal health information from the Investigator.
Information about you that will be seen, collected, used and disclosed in this study:


Your answers to interview questions about you, your family, and your experience with home visiting

Page 27

Who do I call if I have questions?
Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If
you have questions later, you may call Dr. Whitesell at 303-724-1456 or email her at
Nancy.Whitesell@ucdenver.edu. You may also ask your Home Visitor questions you have or call your home
visiting program at [XXX-XXX-XXXX]. When you call, let them know you have a question about the MUSE
research study.
You may have questions about your rights as a participant in this study. You can call Dr. Whitesell with
questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 or
LOCAL IRB INFO.
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No

Signature: ____________________________________ Today’s Date: ________

I explained the MUSE study to the caregiver and answered questions. I believe the caregiver understands what is
expected during this study.
Consent form explained by: ____________________________________

Today’s Date: ________

Page 28

PROFESSIONAL OVER 18 QUALTITAVE CONSENT
Study Title:
Multi-Site Implementation Evaluation of Tribal Home Visiting (MUSE)
Principal Investigator: Nancy Rumbaugh Whitesell, Ph.D.
COMIRB No:
18-0109
Version Date:
January 17, 2019
Version #: 3
Informed consent for: Home visiting professional

You are being asked to be in a research study. This form provides you with information about the study. Your
home visiting program is participating in this study with other tribal home visiting programs across the country.
Please read the information below and ask questions about anything you don’t understand before deciding
whether or not you want to participate in this study.
Why is this study being done?
We are doing this study to learn about tribal home visiting programs. We want to learn about the children and
families receiving services as well as the experiences of leadership and staff who work on these programs. This
study may help programs by identifying what is working well and where services can be improved. It may also
help programs to better understand the families they are serving.
We are asking you to be in this research study because you are currently employed by a tribal home visiting
program. We want to know about your experience working with your home visiting program.
17 tribal home visiting programs are involved in the MUSE study.
We will ask families receiving home visiting services and program staff to be in the study. Up to 1,606 people will
be included. Within this larger MUSE study, we will also interview up to 100 program staff.
What happens if I join this study?
You may have been taking part in other parts of the MUSE study. We are now asking you to be interviewed
about your experiences with home visiting.
If you agree to be interviewed, you will:
1. Talk with someone from the MUSE team about you, the agency or organization where you work and your
experience with your home visiting program.
2. You will be interviewed in a private office. Only you and the interviewer will be able to hear your
conversation.
3. At the time of the interview, you will be asked to let us record the interview (audio only). If you agree, we
will later transcribe the recording and remove any names you mention.
4. MUSE study team members will then share some of what they learn from these interviews in presentations,
or written reports, or articles in professional journals. Anything shared from the interviews will be written or
presented in a way that does not identify you, anyone you discuss in the interview, your home visiting
program or your community.

Page 29

How long will the MUSE study last?
The full MUSE study will last for about 2 years. The interview you are being asked to participate in will happen
one time and will take between one and two hours.
What are the possible discomforts or risks?
The interview asks about your experiences at work with your home visiting program. Some of these questions
may make you feel uncomfortable.
There is a small risk that your personal information will accidentally become known. We take steps to make this
unlikely. We will assign you an ID number and use this ID instead of your name on your interview transcript to
keep your information private.
There are sometimes when we cannot keep your information private because we want to make sure people are
safe. If you tell us about child, spousal, or elder abuse or neglect, we have to report that to Social Services or the
appropriate authority, as per tribal and state legal codes. If you tell us that you are going to physically hurt
yourself or someone else, we have to report that to the police.
What are the possible benefits of the study?
This study is being done to learn more about home visiting services in Native communities. You will not benefit
directly from being in this study.
Who is paying for this study?
This research is being paid for by the Administration for Children and Families Office of Planning, Research, and
Evaluation, through a contract to James Bell Associates, Inc. and the University of Colorado. The Administration
for Children and Families is one of the funders of your home visiting program.
Will I receive anything for being in the study? Will participating in the study cost me anything?
You will not be paid for being in the study.
It will not cost you anything to be in the study.
Is my participation voluntary?
Taking part in this study is voluntary. You have the right to choose not to take part in this study.
If you choose to be in the study, you have the right to stop at any time. If you choose not to be in the study, you
will not be penalized.

Page 30

Who will see my research information?
The University of Colorado Denver and the hospital(s) it works with have rules to protect information about you.
Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also protect
your privacy. This part of the consent form tells you what information about you may be collected in this study
and who might see or use it.
The institutions involved in this study include: University of Colorado Denver and James Bell Associates, Inc.
We cannot do this study without your permission to see, use and give out your information. You do not have to
give us this permission. If you do not, then you may not join this study.
We will see, use and disclose your information only as described in this form and in our Notice of Privacy
Practices; however, people outside the University of Colorado Denver, its affiliate hospitals, and James Bell
Associates, Inc. may not be covered by this promise.
We will do everything we can to keep your records a secret. It cannot be guaranteed.
The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose
your information at any time by writing to the study’s Primary Investigator, at the name and address listed
below. If you do cancel your permission to use and disclose your information, your part in this study will end and
no further information about you will be collected. Your cancellation would not affect information already
collected in this study.
Dr. Nancy Rumbaugh Whitesell
University of Colorado Anschutz Medical Campus
Mail Stop F800
Nighthorse Campbell Native Health Building
13055 E. 17th Place, Room 333
Aurora, Colorado, 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who
have a legal right to see that information.
 Federal offices such as the Food and Drug Administration (FDA) that protect research subjects like you.
 People at the Colorado Multiple Institutional Review Board (COMIRB).
 The study director and the rest of the study team at the University of Colorado and James Bell Associates,
Inc.
 The Administration for Children and Families, who is the agency paying for this research study.
 Officials at the institution where the research is being conducted and officials at other institutions involved
in this study who are in charge of making sure that we follow all of the rules for research.
We might talk about this research study at meetings. We might also print the results of this research study in
relevant journals. But we will always keep the names of the research subjects, like you, private.

Page 31

Your answers to interview questions about you and your experience working with your home visiting program

Page 32

Who do I call if I have questions?
Dr. Nancy Rumbaugh Whitesell is the lead researcher for this study. You may ask any questions you have now. If
you have questions later, you may call Dr. Whitesell at 303-724-1456 or email her at
Nancy.Whitesell@ucdenver.edu.
You may have questions about your rights as a participant in this study. You can call Dr. Whitesell with
questions. You can also call the Colorado Multiple Institutional Review Board (COMIRB) at 303-724-1055 or
[LOCAL IRB INFO].
Consent to be in this study and use my data
I have read this form about the study or it was read to me. I understand the possible risks and benefits of this
study. I understand and authorize the access, use and disclosure of my information as stated in this form. I know
that being in this study is voluntary. If I choose to be in this study, I will get a copy of this consent form.
Do you want to be in the study at this time? (Check one box)
 Yes
 No

Signature: ____________________________________ Today’s Date: ________

I explained the MUSE study to the participant and answered questions. I believe the participant understands
what is expected during this study.
Consent form explained by: ____________________________________

Today’s Date: ________

Page 33

File Type	application/pdf
File Modified	2019-02-27
File Created	2019-02-27