Consent Template HIPAA The Children's Hospital of Research

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.

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.

Contact Information

Friend 1 and Friend 2 contact information will be collected to help keep in touch.

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.

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.

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.

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.

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.

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:

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:

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.

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.

This study has been explained to me and I agree to take part.

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.