STUDY TITLE:
Type 1 Diabetes
EXercise Initiative
Pediatric Study (T1DexiP):
The
Effect of Exercise on Glycemic
Control in Youth with
Type 1 Diabetes
In this form, when it
says "you" it is referring
to you as the
participant if you are an
adult, or to the person
under your care that
would be in the study
if you are a legally
authorized representative
(LAR). Please see the
section called "Legally
Authorized
Representatives (LAR)" for
more information about
who can be a LAR.
This would be like a parent
reviewing the information
for their child
to be in the study. In this
case, "you" would mean
"your child."
If you are the LAR,
you will need to review
this form and discuss
this study with your
child before agreeing
to participate. If you
child does not want
to participate, do not
agree to be in the
study.
SUMMARY
This consent form
will give you important
information about this
study.
It will help you decide
if you would like to
take part in the study.
You do not have to be
in this study. You can
stop the study at any
time.
-
The study is being
done to find out how
blood sugar changes
during
exercise in youth with type
1 diabetes.
- This is a data
collection study. There
are no experimental
study
procedures.
- You will be
asked to be in the study
for about 10 days after
you
complete training and begin data
collection.We
may ask you
to try to begin
the study
on a certain day.
You will
provide information
through online questionnaires.
You will wear a continuous
glucose monitor (CGM)
and a physical activity
wearable on your wrist.
You will enter information
daily about exercise
and the food that you
eat into an app on a
smartphone.
You may also enter your
insulin data in an app
if you do not use a
pump.
You
will upload data from
the CGM and other devices
you use for
your diabetes
.
- The most likely
risks to you are discomfort
from wearing the study
provided devices, like
the physical activity
wearable or from
the CGM
sensor. There is a risk
for a loss of confidentiality
or
the possibility that
completion of questionnaires
will make you
feel uncomfortable.
- The possible
benefits are learning
more about your blood
sugar
response to exercise.
The information you
provide may also help
other people.
WHAT IS INFORMED
CONSENT?
You are being asked
to take part in a research
study. Taking part is
voluntary. You can choose
whether or not you want
to be part of the study.
You can take as much
time as you need to
think about whether
or not you
want to be in this study.
You can also discuss
the study with friends,
family, or doctors to
help you decide. Please
read this document carefully.
Do not agree to be in
this study unless all
of your questions have
been
answered. If you decide
to be in the study,
you will need to indicate
at
the end of this form that
you want to be in the
study. You will be able
to
print a copy of this form
for your records.
If you have any questions
before you decide to
participate, you can
call
the T1-DEXIP Study staff at
813-975-8690 or email
T1DEXIP@jaeb.org.
WHO IS DOING THE
STUDY?
This study is being
done by the Jaeb Center
for Health Research
(JCHR) and
a team of researchers throughout
the United States and
Canada. The
researchers are interested
in learning more about
the impact of exercise
on
type 1 diabetes. It is being
paid for by Helmsley
Charitable Trust.
WHAT IS THE PURPOSE
OF THIS STUDY?
The purpose of this
study is to learn how
exercise affects blood
sugar in
youth with type 1 diabetes.
We expect that 250 people
will take part in
this study. You will be
asked to be in the study
for about 10 days from
when you complete training
and begin data collection.
WHO CAN PARTICIPATE
IN THIS STUDY?
In general, to take
part in this study,
you must:
1. Be at least 12 years
old and not yet 18 years
old.
2. Have been diagnosed
with type 1 diabetes
for at least 3 months.
3. Use an insulin pump
(including a closed-loop
system that is commercially
available) or multiple
daily injections of
insulin.
- How you take
insulin must not have
changed in the last
month.
- If you take multiple
daily injections of
insulin you must use
a device that records
the
injection doses and/or
be willing to enter
insulin
doses through a study app.
4. Use a Dexcom G6 continuous
glucose monitor (CGM)
regularly. If you do
not use a Dexcom G6
CGM, you must be willing
to wear one during the
study.
5. Use a smartphone
that is compatible with
the apps that will be
used in the study. If
you do not use a smartphone
that is compatible with
the study apps, you
must be willing to use
a study provided loaner
iPhone.
6. Have access to a
compatible computer
and internet that you
can use to
download your CGM and pump
data and complete questionnaires.
7. Be at least moderately
active on a regular
basis.
8. Be willing to follow
the study procedures.
9. Live in the United
States for the duration
of the study.
10. Understand written
and spoken English.
Also, you cannot:
1. Usually use a premix
insulin. Premix insulins
include Humalog®
Mix
25TM, Humalog®
Mix 50TM,
NovoMix® 30,
Humulin® 30/70, Novolin®
ge 30/70, Novolin®
ge 40/60, or
Novolin® ge 50/50.
2. Usually use a Regular
insulin. Regular insulins
include Novolin®
R,
Humalin® R, Humalin®
R U500 or Novolin ReliOn
Insulin.
3. Be pregnant or plan
to become pregnant while
you are in the study.
4. Have had two or more
severe hypoglycemic
(low blood sugar) events
in the
past 12 months that required
help from another person
to treat.
5. Have been hospitalized
overnight for blood
sugar control three
or more
times in the past 12 months.
6. Take oral glucocorticoids
during the study. Prednisone
is an oral
glucocorticoid.
7. Have been diagnosed
with cystic fibrosis.
8. Have a physical or
developmental impairment
that would limit activity
or
ability to use the apps
or devices in the study.
9. Have participated
in another research
study where you used
an
investigational drug or
device in the last 30
days.
10. Plan to be in another
research study in the
next 2 months.
WHAT WILL HAPPEN
IN THIS STUDY?
If you agree to be in
the study, we will ask
you to (1) complete
questionnaires; (2)
use a physical activity
wearable during the
study; (3)
use study apps to enter
information daily about
exercise, food and insulin;
(4) wear a Dexcom G6
CGM during the study;
and (5) upload device
data from
your diabetes devices (pump
or CGM).
We will send you the
supplies that you need
for the study. We will
give you
instructions so that you
can learn to use the
devices and the apps
for the
study. The study website
will have online instructions.
Instructions may
include videos that may
have links to YouTube
and other websites.
You will have a video
visit using something
like FaceTime or Zoom
or a
phone call with a member of
the study staff before
you start the study.
These video visits will
not be recorded. The
study staff will provide
more training during
the study to help you
with
the study procedures. They
will also follow up
with you on any questions
about the study data.
Your parent can attend
the video visits with
you.
1.
Questionnaires
First, we will ask you
to complete online questionnaires
to make sure you
qualify to participate.
We will ask you about
your normal physical
activity. You will also
complete online questionnaires
that ask about your
diabetes medications
and management, your
growth and physical
development,
and demographic information.
We will ask you questions
about fears related
to low blood sugar and
your experience with
low blood sugar. The
questions
should take about 30 minutes
to answer. Parents can
help children answer
the questions if they
need help.
The parent providing
consent will also be
asked to complete questionnaires.
We will ask about parent's
normal physical activity
and their child's
diabetes management. The
questions should take
about 10 minutes to
answer.
At the end of the study,
you will be asked to
complete a final
questionnaire. You may be
asked to report information
related to exercise.
You will be asked to
report severe hypoglycemia,
DKA, hospitalization,
or
study related injuries during
the study. You will
be asked about any device
issues. If you traveled
outside the time zone
in which you live, we
will
ask you about the dates
of travel and places
that you travelled.
This will
help us to line up the times
on the study devices
that you used when you
travelled. We will ask
females about dates
of menstrual period
and use of medications
that have hormones
because the hormones
that control menstrual
cycles can affect blood
sugar. The questions
should take
about 20 minutes to
answer.
2.
Physical Activity
Wearable
During the study, you
will need to wear a
physical activity wearable
on
your wrist. It will measure
your heart rate, physical
activity level, and
step count. It also
collects information
about sleep duration
and quality.
You may be asked to wear
a physical activity
wearable called the
Garmin
vivosmart. You can view
the information collected
by the physical activity
wearable by using the
Garmin Connect app on
a smartphone.
If
you are asked to wear the
Garmin vivosmart, you
will be able to keep
this
after the study.
3.
Study Apps
You will need to load
all apps needed for
the study onto your
personal
smartphone if it will work with
the study apps. If your
smartphone will not
work with the study
apps, you may receive
a loaner iPhone. You
will only be able to
use the iPhone for the
study. When the study
is over, you will be
instructed to return
the iPhone. The apps
will
use a login and password
provided by the study.
We will set up the accounts
for you or we will help
you to set up accounts
during training.
During the study you
will enter information
daily about your exercise,
activity, insulin use,
and food you are eating
into the BANT app. For
three
days, you will also take
before and after photos
of everything you eat
or
drink. A reference card
will be included in
the food photos to allow
the
photos to be scaled to similar
sizes despite a variety
of plate and bowl
sizes and backgrounds. The
three study days when
you take photos should
include weekdays and
at least one weekend
day.
You will use the Gamin
Connect App with the
Garmin vivosmart physical
activity wearable. The
Garmin Connect App syncs
the data from your physical
activity wearable.
If
the Institutional Review
Board (IRB) says it
okay,
there may be other apps
needed for the study
devices that you will
use.
You may receive smartphone
app alerts or text messages
throughout the
study. Once the study is over,
you will
be reminded to
remove the study apps from
your
personal smartphone.
4.
Continuous Glucose
Monitor (CGM)
A CGM measures the sugar
level in the fluid beneath
the skin. The CGM
system includes a sensor
with a thin needle and
a small wire that is
inserted under the skin,
a transmitter that attaches
to the sensor and a
receiver that collects
the sugar results. Once
inserted, the needle
is
removed, and the sensor
wire remains.
If you use a Dexcom
G6 CGM, you will continue
to use your personal
Dexcom
G6 CGM during the study.
You will be given instructions
on how to send your
CGM data during the
study.
If you do not use a
Dexcom G6 CGM, we will
ask you to wear a blinded
Dexcom
G6 Pro CGM during the whole
study. A blinded CGM
records blood sugar
levels, but you won't
be able to see the results.
If you use a personal
CGM
you should continue to use
your personal CGM during
the study. The Dexcom
G6 Pro CGM supplies
that you will need for
the study will be sent
to you
with instructions. You may
need to replace your
CGM during the study.
We
will give you instructions
for starting and replacing
the CGM.
You may receive an Android
phone to use with the
Dexcom G6 Pro CGM
supplies. The phone will
collect the data from
the Dexcom G6 Pro CGM.
This
will help us to make sure
that data are being
collected from the CGM.
You
will not be able to use
the Android phone for
phone calls or other
purposes. When the study
is over, you will be
instructed to return
the
Dexcom G6 Pro CGM supplies
and the Android phone.
If you use the blinded
Dexcom G6 Pro CGM during
the study, you will
be able
to review your sugar readings
at the end of the study.
If you have missing
CGM data during the
study, you may be asked
to
participate in the study
again.
5.
Insulin Use
If you use an insulin
pump, you will upload
the data from your pump
during
the study. We will give
you instructions on
how to upload your pump
data.
If you take insulin
by multiple daily injections,
we will ask you to record
your insulin doses and
times through the BANT
app during the study.
If you
use an FDA approved smart
pen, we may ask you
to upload data from
your pen.
We will give you instructions
on how to send data
from your smart pen
during the study. An
app, like the Tidepool
Mobile app may be used.
This
app can collect insulin
delivery data from Apple
HealthKit.
6.
Saliva Sample for
Genetic Information
At
the end of this form,
we will ask
if you want to provide
a saliva sample for
the study. If you agree
to
provide a saliva sample,
we will mail you a saliva
sample kit. You will
collect a saliva sample
by spitting into a tube.
After you collect your
sample, you will send
it to a
laboratory
at the Center for Public
Health Genomics at the
University
of Virginia
in a prepaid shipping
package. The laboratory
will use the DNA from
your
saliva sample to look at
genetic information.
The
laboratory will need
some additional information
about you for the
testing, like age and sex.
This information will
not identify you.
The laboratory will
look at specific places
in the genetic information.
This may help us learn
more about diabetes,
exercise, and the effect
of
exercise on blood glucose.
The purpose of the genetic
research is not to diagnose
any disease or
abnormality that you may
have. We will not provide
any information or DNA
results to you.
The
genetic information
from the saliva sample
will be added to a
database with the rest
of your study information.
This database will be
used for future diabetes
research but will not
have any information
that could easily identify
you.
When the study is done,
any leftover saliva
or DNA will be thrown
away.
You
can still be in the
study if you do not
want to provide a saliva
sample.
WHAT ARE THE RISKS
OF THIS STUDY?
It is not expected that
there would be any significant
risks from being in
this study other than
a possible risk to confidentiality
or possibly
getting upset from questions
asked.
Physical Activity
Wearable Risks
You could experience
some discomfort from
wearing a physical activity
wearable. This includes
redness, irritation,
swelling, bumps, skin
irritation and discomfort
on your skin. If any
irritation occurs while
wearing the device,
remove the device and
notify the study staff.
Risks Related
to Questionnaires and
Interviews
We will ask you questions
about your diabetes,
medical history, and
your
typical activity. You will
also be asked about
your physical development.
Though uncommon, it
is possible that some
people may find these
questions a
little bit upsetting. If
any questions make you
uncomfortable, you can
refuse to answer, unless
the information is needed
to make sure that you
are eligible for the
study, to set up devices
needed for the study,
or to
calculate a score for a
questionnaire. You can
decide to take a break
or
stop taking part in the
study at any time.
Risks Related
to Genetic Information
You may agree to provide
a saliva sample to help
us learn more about
diabetes, exercise,
and the effect of exercise
on blood glucose. We
are
only looking at a limited
amount of your genetic
information from your
saliva sample. We are
not measuring your entire
DNA sequence (called
your
genome). We are looking at genetic
information that
would
not be useful as part
of your regular care
. It is very unlikely
that someone could identify
you through the genetic
information collected.
A federal law called
the Genetic Information
Nondiscrimination Act
(GINA),
generally makes it illegal
for health insurance
companies, group health
plans, and most employers
to discriminate against
you based on your genetic
information. Be aware
that this federal law
does not protect you
against
genetic discrimination by
companies that sell
life insurance, disability
insurance, or long-term
care insurance. GINA
also does not protect
you
against discrimination if
you have already been
diagnosed with the genetic
disease being tested.
Unless
required by law, we
will not be sharing
your genetic information
with anyone other than
the researchers looking
at diabetes. This
information will not identify
you.
Risks to Confidentiality
This study will be capturing
some information about
you that includes
identifiable, personal information,
like your name and the
name of your
parent providing consent,
your date of birth,
your mailing address,
email
addresses and phone numbers
for you and your parent
providing consent. This
information needs to
be collected as part
of the study so that
we may
contact you during the study
and ship you study supplies.
The study has
procedures in place to protect
that information. There
is a chance that a
loss of that protection
could occur. This would
be a loss of
confidentiality. Please
see the "How will my
information be protected
and
kept confidential" section
below for more information.
The study staff may
use your contact information
to call, text or email
you
during the study. They may
do this to send you
things like reminders
to
enter information in the
study apps. They are
not allowed to send
you
identifiable health information
by text or email because
it is unsecure.
This means that there is
a risk that a message
may be seen by someone
that
is not supposed to see it,
like when an email gets
hacked. Your email,
phone number, your name,
or the name of your
parent providing consent
will
likely be in the text or
email. If you think
that the study staff
have
texted or emailed information
that they should not
have please contact
JCHR
at 813-975-8690 and ask
to speak to the IRB
Administrator. If you
text or
email the study staff it
is unsecure and what
you put in the text
or email
is not protected. You will
receive text messages
throughout the data
collection period as
needed.
The wearables and apps
may send you automated
reminders too.
WHAT ARE THE BENEFITS
OF TAKING PART IN THIS
STUDY?
People who take part
in this research study
will add to new knowledge
that
may help other people with
type 1 diabetes. You
may also learn more
about your blood sugar
response to
exercise.
CAN I STOP BEING
IN THE STUDY?
You can stop being in
the study at any time.
The study may stop at
any
time, or the study team
can stop your participation
at any time. You do
not
have to give permission
for the study to stop,
or for your participation
to
be stopped by the study
team. You will be told
if this happens. If
you stop
being in the study, please
be sure to remove the
study apps from your
phone
and
return all study supplies
(study phone and study
CGM, if provided).
The study team may also
remove you from the
study if they feel it
is in
your best interest or the
best interest of the
study.
ARE THERE COSTS
RELATED TO TAKING PART
IN THE STUDY?
This is a data collection
study so it is not expected
that there will be
any costs related to being
in this study.
We
will provide
the physical activity
wearable. You may keep
the physical activity
wearable
after the study. If you
do not currently use
a Dexcom G6 CGM, you
will
receive Dexcom G6 Pro CGM
supplies for use during
the study. An Android
phone may be provided
to collect data from
the Dexcom G6 Pro CGM.
You must
return the Dexcom G6 Pro
CGM
and Android phone
after you finish the
study. If your smartphone
will not work with the
study apps, you may
receive a loaner iPhone.
You must return the
iPhone after you finish
the study.
Costs of standard medical
care for diabetes, including
insulin, that would
occur even if the participant
were not in this study,
will be the
participant's responsibility
like
it would be normally.
IS THERE PAYMENT
FOR TAKING PART IN THIS
STUDY?
If you take part in
the study, you will
receive
up
to $100 in gift cards
at the end of the study.
You will receive
payment for meeting
the goals for using
the Bant app. You will
also
need to complete the
end of study questionnaires,
device uploads if
applicable, and return
study supplies if applicable.
|
|
Amount
|
Maximum Total
|
|
Enter activity, insulin
if you take multiple
daily injections and
food photos in BANT
app for 3 days during
the study
|
$15 per day
|
$45
|
|
Enter activity and insulin
if you take multiple
daily injections for
5 other days during
the study
|
$5 per day
|
$25
|
|
Complete of end of study
questionnaires, any
device uploads that
are needed, and return
of study supplies if
needed
|
$30
|
$30
|
|
Maximum Amount Possible
|
$100
|
|
WHAT HAPPENS IF
I HAVE AN ILLNESS OR
INJURY FROM BEING IN
THE STUDY?
This is a study with
minimal risk. For this
reason, it is not expected
that
there would be any study
related illness or injury.
If you have an illness
or injury that is related
to your participation
in the study, then you
can
get care like you normally
would. The study does
not plan to provide
costs
for care or other expenses
relating to illnesses
or injuries.
CONTACT INFORMATION
FOR QUESTIONS OR PROBLEMS
If you have any questions,
concerns or suggestions
about this study, then
please contact the T1-DEXIP
study team at 813-975-8690
or
T1DEXIP@jaeb.org.
Also, you can contact
the Jaeb Center for
Health Research Institutional
Review Board (IRB) Office
at 813-975-8690 or
irb@jaeb.org
if you:
· Have questions
about your rights as
a research participant
· Wish to talk
about your concerns
or suggestions about
the research
· Want additional
information about the
research, or
· Want to provide
comments about the research.
HOW WILL MY INFORMATION
BE PROTECTED AND KEPT
CONFIDENTIAL?
As required by law,
study-related records
with identifying information
will
be kept confidential. Safety
measures for the access,
security, and privacy
of your information
have been put in place
by law. Unless the law
requires
it, your name, email address,
or any other direct
identifying information
will not be used to
identify you.
Purpose of Authorization
We have rules to protect
information about you.
Federal and state laws
also
protect your information.
By signing this form
you are giving your
permission, called your
"authorization," for
the use and disclosure
of
information protected by
the law.
You must sign this form,
including the Protected
Health Information Authorization
statement in the
signature box at the end
of this form if you
want to be in the study.
When
you sign the form, you give
permission for the use
and sharing of your
Protected Health Information
(PHI) for the study.
PHI is health information
that identifies you.
Your authorization is
beneficial and important
for the
study. Without your authorization,
you will not be able
to be in this
study.
Using and Sharing
Your PHI
Information will be
collected about you
in this study. This
information
includes your name and the
name of your parent
providing consent, email
address, date of birth,
phone number, mailing
address, and travel
outside
the time zone where you
live. These are examples
of identifiable
information. A copy of the
information may be kept
in a database at JCHR.
This will allow the
new information to be
linked to this other
information
and may include the PHI
described.
The
wearables and apps used
in the study will be
collecting information
about you. It is possible
that you might enter
in some of your
identifiable information
into an app, like your
email address and date
of birth. The companies
have privacy policies
that protect your
information. They can use
some of your data collected
through their
wearables and apps, but
they can only do that
with grouped information
of many people. They
will not use or share
any information that
could
easily identify you. Their
privacy policies are
available on their
websites.
Study results without
the identifiable information
may be shared in medical
journals and at scientific
meetings. Your records
will be confidential.
No
one will share your identity
in a medical journal
or at a scientific
meeting. Results from the
study will not be sent
to you.
Who Can Receive
and Use Your Study Information?
It is possible that
people outside the Jaeb
Center may need to see
or
receive your information
from this study. Some
examples include government
agencies (such as the
National Institutes
of Health), committees
that
monitor safety, other sites
in the study, and companies
that sponsor the
study. In most cases the
information will
have a code number with
it instead of your name
or email address.
There are some situations
where the information
will not have
a code
number but may include your
name, email address,
or phone number. Everyone
who needs to see your
information will be
told it is confidential,
but we
cannot guarantee full confidentiality.
Can You Cancel Your
Authorization?
You may cancel your
permission for the use
and sharing of your
study PHI at
any time. You will need
to contact the JCHR
IRB to cancel this.
When you
cancel your permission or
when you withdraw from
the study directly,
you
are no longer part
of the study. No new
information about you
will
be gathered for the study.
The Jaeb Center will
receive all the information
that was collected for
the study up to the
time that you cancel
or withdraw
from the study.
When Will the Use
and Sharing of Your
PHI Stop?
Some of your study PHI
does not have
a code number with it.
Your
permission for the use and
sharing of your PHI
lasts 50 years from
the date
that you sign this form
or until the end of
the study, whichever
comes
first. The rest of your
study information does
have a code number with
it.
When it is collected, it
becomes part of a research
report. Your permission
for the use and sharing
of this coded information
will never end. This
coded data does not
have your name or email
address.
Other Considerations
The information collected
in the study may be
used in future studies
without additional permission
from you. This may include
research done by
other researchers. The information
that may be shared will
not
contain any information
that could identify
you. There may still
be a
chance that someone could
identify you, but this
is not likely.
After the study is completed,
the Jaeb Center for
Health Research in Tampa,
FL may share your information
collected as part of
the study with the
Helmsley Charitable Trust
in New York, NY. Your
information collected
as
part of this study may be
stored, maintained,
or used for future research
by the Helmsley Charitable
Trust.
A copy of the information
collected as part of
the study will be made
public in a dataset.
This will be done after
the study ends. This
dataset
will not contain any PHI.
The study results will
also be made public.
These
results will not have any
information that could
identify you.
Contact from the
Jaeb Center
You will need to provide
your name and mailing
address so that we can
ship
the study supplies to you.
You and your parent
providing consent will
need
to provide an email address
and a cell phone number
to receive
notifications as a means
of identification and
to receive communications
from the study staff
at JCHR or at other
places.
You will have communication
with the study staff
by phone, email, text,
or
by video (like FaceTime
or Zoom). You may also
receive text messages
from
through a third-party texting
service. There is a
chance that someone
could
see or hear the conversation
like they could if you
were speaking or
texting with anyone.
If you do not want to
provide contact information
or receive study
communications, you should
not agree to take part
in the study. If you
decide later that you
no longer not want to
receive study communications,
you will not be able
to stay in the study.
The Jaeb Center for
Health Research will
be provided with your
email
address to send emails on
further opportunities
for you to participate.
You
do not need to participate
if you do not want to.
AUTHORIZATION AND
AGREEMENT TO BE PART
OF THE STUDY
If you agree to take
part in the study, please
click the 'I agree to
take
part in this study' button
below. Clicking the
button below signs this
document.
Legally Authorized Representatives
(LAR)
If you are deciding
for another person whether
that person will take
part in the study, it
is important that you
understand who is a
legally authorized
representative (LAR).
A LAR for a
minor under the age of 18
is a natural or adoptive
parent, a legal
custodian, or a legal guardian.
A LAR for an adult who
lacks capacity
to consent can be an attorney
in fact, a court appointed
guardian, or
an individual's spouse,
adult child, or parent
(in that order). This
means that if an adult
who lacks capacity to
consent has a
court-appointed guardian,
then the spouse would
not be permitted to
serve as the LAR.
Check the box
below if you are serving
as a LAR
I am signing this
document as a LAR for
another individual
Relationship to
study participant
:
If you only want to
be part of this study
and you do
NOT want to
be contacted by email about
future studies or other
opportunities for which
you might be able to
participate, check this
box.
(If you do not check
this box now, you will
be able to opt out of
receiving additional
information at any time
in the future).
By entering your information
and clicking the box
below, you are confirming
that you have read this
document and want to
be part of the study.
You also
are authorizing the use
and disclosure of your
protected health information
as described. This information
is collected as part
of participation in
this study. You cannot
be in this study if
you do not provide this
permission. Clicking
the box below is the
same as signing your
name.
Name of LAR providing
consent:
Email address (this
will be used to contact
the LAR):
Re-enter email address:
Today's date
9/18/2021
I agree to take
part in this study
Minor's Legally Authorized
Representatives (LARs)
Assent
Attestation
By entering your child's
information and clicking
the box below, it means
that:
· you confirm that
the study has been explained
to the child by you
or
in your presence in a language
that the child could
understand.
· you confirm that
the child was told to
ask questions and the
questions were answered
so the child could understand.
· you confirm that
the child has expressly
stated that he/she wants
to
be in the study at this
time.
Name of Participant:
Email address of participant
(this will be used to
identify participant's
data in the study):
Re-enter participant's
email address:
Participant's date of
birth
My child assents
to take part in this
study
Permission to Obtain
Saliva Sample for Genetic
Information
The DNA obtained from
your (study participant)
saliva specimen will
be used
to look at genetic information.
We will not provide
any information or DNA
results to you. When
the research study is
done, any leftover saliva
or DNA
will be thrown away. Clicking
one of the boxes below
is the same as signing
your name.