Consent Template: Combined HIPAA - The Children's Hospital of ...

Informed Consent Form and HIPAA Authorization
Study Title: The Down Syndrome Growing Up Study
IRB #: 09-007306
Version Date: December 8, 2009,
Principal Investigator: Babette Zemel, PhD Telephone: 215-590-1669
Affiliations:
The Children’s Hospital of Philadelphia,
Department of Pediatrics
Study Sponsor:
The Centers for Disease Control and Prevention
You, or your child, may be eligible to take part in a research study. This form gives you
important information about the study. It describes the purpose of this research study, and
the risks and possible benefits of participating.
If there is anything in this form you do not understand, please ask questions. Please take
your time. You do not have to take part in this study if you do not want to. If you take
part, you can leave the study at any time.
Parents or legal guardians who are giving permission for a child, please note: in the
sections that follow the word ‘you’ refers to ‘your child.
Why are you being asked to take part in this study
You are being invited to take part in this research study because you have Down
syndrome. All children with Down syndrome in the Greater Philadelphia area are being
asked to take part in this study.
What is the purpose of this research study
The only growth charts for children with Down syndrome in the United States are several
decades old. The purpose of this research study is to create more accurate and up-to-date
growth charts for children with Down syndrome.
How many people will take part
About 580 children and young adults with Down syndrome will take part in this study at
CHOP.
What is involved in the study
The study involves measuring how children and young adults with Down Syndrome grow
over time. The study will last a total of four years, so your participation will last for up to
four years depending on your age and when you enroll in the study.
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CHOP IRB#: IRB 09-007306
Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 1 of 8

Study Procedures:
We will ask you for your contact information (address, phone numbers and email
address) and that of two other friends so that we may be sure we can keep in touch with
you in the event you move. We will also ask you for the contact information of your
doctor and your school.
Growth Assessment
We will measure growth in a few different ways. For infants, some of these measures will
be taken without clothing. Children, teens and young adults will be measured wearing
shorts and a t-shirt, or a hospital gown or hospital scrubs. This will make it easier to get
correct measurements. Most measurements will be taken three times to get the most
accurate measurement. We will measure weight on an electronic scale. Babies will be
weighed on an infant scale and all others will be weighed on a standing scale.
For children less than two to three years of age, we will measure length, laying down on a
length board. One person will hold the baby’s head in the right position and another
person will stretch out their legs. We will then lift up the baby’s legs and measure from
their head to their bottom.
For children 2 to 3 years of age, and older, we will measure height using a “stadiometer”
which is how most pediatricians measure height. We also will measure body and head
height by having the child sit down on a stool with their body against the stadiometer.
This is called a “sitting height”.
Using a regular tape measure, we will also measure head size, waist size and upper arm
size. We will then measure skinfold thickness, which helps tell how much fat is
underneath the skin. Skinfold thickness will be measured in four places; on the front and
back of the arm, on the back and the belly. These measurements are taken with a
“skinfold caliper” which feels like a gentle squeeze when it takes the measurements.
It will take about 20 minutes to complete the growth measurements.
Questionnaires
Children and young adults seven years of age or older, and their caregivers will be asked
to complete a questionnaire about puberty (the changes in the body as children become
adults) based on a description sheet with pictures. Caregivers and young adults will also
be asked to fill out a few forms which ask about the following information:
• Age, race, and ethnicity and the kind of educational program the child or young
adult attends.
• Previous hospitalizations and surgeries or current medical problems, medications
the child is currently taking and has been on in the past.
• Sports or physical activities the child or young adult does each week as well as
how much time is spent in more passive activities, such as watching television or
playing electronic games.
• Age-appropriate questions about feeding problems.
• Parents/guardians will also provide some information about their education level,
household income and their height and weight.
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Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 2 of 8

It will likely take between 30 to 45 minutes to finish all of the questionnaires.
Visit Schedule
The table below provides a schedule of the study visits.
Age Range
Birth to 12 months
Frequency of Visit
Every 3 months
12 to 36 months Every 6 months
3 to 20 years Every 12 months
Discontinuation
The study doctor may take you out of the study if there is a reason. Some of the reasons
the doctor may take you out of the study include:
• You cannot meet all the requirements of the study.
What are the risks of this study
Taking part in a research study involves inconveniences and risks. If you have any
questions about any of the possible risks listed below, you should talk to your study
doctor or your regular doctor.
This study involves growth measurements and questionnaires. The potential risks are
very small. The skinfold thickness measurements are taken with calipers that carry a rare
risk of minor bruising. The sexual maturity exam can be done with the assistance of a
parent/guardian or trained research personnel in a private setting to minimize any feelings
of discomfort.
Everyone in the study will get their own ID number to minimize the risk associated with
the collection of personal health information.
Are there any benefits to taking part in this study
The child, young adults and/or care givers, as well as the primary care doctor, will get a
summary of your growth measurements at each visit. There will not be any other direct
benefit of participation in the study.
The indirect benefit of study participation is your growth measurements will be combined
with those of other children and used to create new growth charts just for children with
Down syndrome. Your measurements will also help determine the best way to screen
children with Down syndrome for overweight or obesity. This information will benefit all
children with Down syndrome in the future.
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Expiration Date: 11/7/2011 Page 3 of 8

Do you need to give your consent in order to participate
Once you read this form and had your questions answered, you will be asked to decide if
you wish to participate. If you wish to participate in this study, you must sign this form.
A copy will be given to you to keep as a record.
What happens if you decide not to take part in this study
Participation in this study is voluntary; you do not have to take part in order to receive
care at CHOP. If you decide not take part or if you change your mind there will be no
penalties or loss of any benefits to which you are otherwise entitled. Your current and
future medical care at CHOP will not be affected by your decision.
Are there alternatives to participation in this study
The alternative to participation in this study is to not participate.
What about privacy, authorization for use of Personal Health Information (PHI)
and confidentiality
We need to collect health information about you in order to conduct this study. This
includes information about you from the measurements and questionnaires that are part of
this research. We will do our best to keep your personal information private and
confidential. However, we cannot guarantee absolute confidentiality. Your personal
information may be disclosed if required by law.
The results of this study may be shown at meetings or published in journals to inform
other doctors and health professionals. We will keep your identity private in any
publication or presentation about the study.
People and organizations that may inspect and/or copy your research records to conduct
this research, assure the quality of the data and to analyze the data include:
• Members of the research team at CHOP;
• Medical staff who are directly or indirectly involved in your care related to this
research;
• People who oversee or evaluate research and care activities at CHOP;
• People from agencies and organizations that perform independent accreditation
and/or oversight of research; such as the Department of Health and Human
Services, Office for Human Research Protections.
• Representatives of the U.S. Centers for Disease Control and Prevention who is the
study sponsor funding this research.
By law, CHOP is required to protect your health information. The research staff will only
allow access to your health information to the groups listed above. By signing this
document, you are authorizing CHOP to use and/or release your health information for
this research. Some of the organizations listed above may not be required to protect your
information under Federal privacy laws. If permitted by law, they may be allowed to
share it with others without your permission.
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There is no set time for destroying the information that will be collected for this study.
Your permission to use and share the information and data from this study will continue
until the research study ends and will not expire. Researchers continue to analyze data for
many years and it is not possible to know when they will be completely done.
What are my rights and responsibilities as a research subject
Taking part in a research study involves time and responsibilities. You need to keep all
study appointments. Please consider the study time commitments and responsibilities as
a research subject when making your decision about participating in this study.
You may change your mind and take back your authorization to use and disclosure your
health information at any time. Even if you take back your authorization, we may still
use and disclose the health information we have already obtained about you as necessary
to maintain the integrity or reliability of the current research. To take back your
authorization, you must send a letter to Dr. Zemel. In the letter, you must say that you
changed your mind and do not want us to collect any more health information about you.
If you ask that we no longer collect your health information you will have to leave the
study.
Financial Information
Will there by any costs to you
There will not be any costs to you for participating in this study.
Will you be paid for taking part in this study
You will not receive any payments for taking part in this study. Your parent/guardian will
receive $25 for each study visit to offset the time and inconvenience associated with the
study visit. You will get a $5 gift certificate as a thank you for your participation in each
study.
Who is funding this research study
This study is funded by the U.S. Centers for Disease Control and Prevention.
Please ask Dr. Zemel if you have any questions about how this study is funded.
What if you have questions about the study
If you have questions about the study, call the study doctor, Dr. Zemel at 215-590-1669.
You may also talk to your own doctor if you have questions or concerns.
The Institutional Review Board (IRB) at The Children’s Hospital of Philadelphia has reviewed
and approved this study. The IRB looks at research studies like these and makes sure your rights
and welfare are protected. You can talk to a person from this group if you have questions about
your rights as someone taking part in a research study. You can call the IRB Office at 215-590-
2830 if you have questions or complaints about the study.
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Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 5 of 8

Consent for Use of Data for Future Research
As part of the study, we will collect information about your growth and health. These
data will be given a unique code and will include no information that can identify you. A
Master List will be kept that links your data to you. This information will be kept in a
separate, password protected computer database at the Research Institute of the
Children’s Hospital of Philadelphia. Only the study doctors and those working with them
on this study will be able to see information that can identify you.
If you leave the study, you can ask to have the data collected about you removed or your
samples destroyed. You can also ask us to remove information that identifies you from
the data.
We may wish to use your stored information in a future study. Please let us know if you
will let us do that by putting your initials next to one of the following choices:
_____ (initials) My data may be used for this study only.
_____ (initials) Provided that my identity stays private, my data may be used for other
future research studies.
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Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 6 of 8

Consent to Take Part in this Research Study and Authorization to Disclose Health
Information
The research study and consent form have been explained to you by:
Person Obtaining Consent
Signature of Person Obtaining Consent
Date:
By signing this form, you are indicating that you have had your questions answered, you
agree to take part in this research study and you are legally authorized to consent to your
child’s participation. You are also agreeing to let CHOP use and share your health
information as explained above. If you don’t agree to our collecting, using and sharing
your health information, you cannot participate in this study. NOTE: A foster parent is
not legally authorized to consent for a foster child’s participation.
Name of Subject
Signature of Subject (18 years or older
and competent to consent)
Date
Name of Authorized Representative
(if different than subject)
Relation to subject:
Parent Legal Guardian
Legally Authorized Representative
Signature of Authorized Representative
Date
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Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 7 of 8

Child Assent to Take Part in this Research Study
For children capable of providing assent:
I have explained this study and the procedures involved to __________________ in
terms he/she could understand and that he/she freely assented to take part in this study.
Person Obtaining Assent
Signature of Person Obtaining Assent
Date
This study has been explained to me and I agree to take part.
Signature of Subject (optional)
Date
For children unable to assent:
I certify that __________________ was not capable of understanding the procedures
involved in the study sufficiently to assent to study participation.
Person Responsible for Obtaining Assent
Signature of Person Responsible
Date
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Approval Date: 11/8/2010
Expiration Date: 11/7/2011 Page 8 of 8