Appendix E.3 Consent Form

Flesch Kincaid Reading Level: 7.4

CASE Consent

Appendix E.3 Informed Consent Document: Case Group

Centers for Developmental Disabilities Research and Epidemiology

Study to Explore Early Development (SEED)

You are invited to be in a research study being done by <or being done with> the Centers for Disease Control and Prevention (CDC). CDC is a federal agency that works to improve the health and safety of the general public. The study is called Study to Explore Early Development (SEED). It is being done by 6 different sites in the US. <Location> is one of the sites taking part in the study.

The study in <location> is being done through a partnership with schools in the <location> area and local healthcare providers. <Site specific…The <federal department of education> gave <CDC> permission to work with the schools.> This data is collected under the authority of Section 301 of the Public Health Service Act.

Your participation will help us understand what causes developmental problems in young children.

What is the purpose of the study?

This is a study on child development. One focus of the study is to look at possible causes of autism. We know that many children have autism and other related disabilities. Autism spectrum disorders (ASD) are a set of disorders that are usually found in early childhood. There are many signs for ASD. The most common signs involve social, communication, and behavioral delays. However, we want to learn more about these children. We also want to learn more about risk factors and possible causes.

We are looking at things that occur during pregnancy or in the early stages of a child’s life. The results may lead to better services and treatments for children with autism and other related disabilities.

Who can participate?

Hundreds of families across the country are being asked to be in the study. More than <number> families living in <location> will be asked to be in the study. Some families were randomly chosen by birth certificate records. The names of other families were given to us by local school systems or healthcare providers. <Site specific…The <federal department of education> gave <CDC> permission to work with the schools.>

We are enrolling families of children with and without developmental disabilities. It is important that different types of families participate. This will help us find clues about what causes children to develop differently. Children should be 2-5 years old as of <insert study year>.

What will my child and I be asked to do in the study?

Families who take part in the study will be asked to do each of the tasks listed below. You can refuse any task and still participate in the study. The tasks include:

1. Complete questionnaires and interviews.

2. Allow project staff to review medical records.

3. Provide a cheek swab sample from the biological parents and your child.

4. Provide about 4 teaspoons of blood. The blood samples will be analyzed for biologic and genetic substances.

5. Allow project staff to conduct a developmental evaluation on your child in the study clinic.

6. Allow project staff to videotape the developmental evaluation.

7. Allow project staff to conduct a brief exam on your child in the study clinic.

8. Allow project staff to take photographs of your child during the physical exam.

9. Allow your child to provide 4 teaspoons of blood. The blood samples will be analyzed for biologic and genetic substances.

10. Allow your child to provide a hair sample. The hair sample will be analyzed for mineral content.

11. Allow project staff to measure the biological parents' head circumferences and record reported heights.

12. Complete diet and stool diaries for your child.

These activities will spread over one clinic visit, which we expect to last about 5 ½ hours, one phone interview which will last about one hour, and finally, filling out some forms with our help before and after these visits, which will take about 4 hours. We ask that you complete all parts of the study. A detailed description of each part of the study is included in the yellow “things you keep” folder. Even if you do not complete all parts of the study you are still considered a study participant. You are allowed to drop out of the study at any time without penalty. We also ask that you to let us contact you for future studies we may conduct.

Are there any risks involved with the study?

There is little risk involved with the study. You may feel nervous answering questions during the interviews. Some questions are sensitive in nature and may cause you to have negative feelings (like feeling embarrassed). You are free to skip any questions that you do not want to answer or that make you uncomfortable to talk about. Your responses will not be shared with people outside of the study.  The evaluation will take several hours and some children may become tired. Short breaks will be offered during the testing.  You may get feedback that is unexpected and/or that indicates some developmental delays that you can share with your health care provider.  The developmental testing results are for research only and do not substitute for a specific diagnosis or indication of treatment. Study personnel will be available to answer questions and will provide a list of local resources. But we will not be able to give a specific diagnosis.

You and your child may feel a little discomfort when having blood drawn. If you request, we can apply a numbing cream to your child’s arm before inserting the needle after discussing with you. Side effects from the cream are uncommon but include temporary redness, paleness and swelling. As in every blood draw, you may get bruising at the puncture site; there is also the rare chance of later infection at the puncture site. Study staff will take every precaution when drawing blood.

Why should I be in the study?

There is no personal benefit to you for taking part in the study. Your participation will help us understand what causes developmental problems in young children. The results of the study may help us learn more about autism and other developmental disabilities. Results may also lead to better services and treatments for children with developmental disabilities. We will analyze the blood, hair, and cheek samples for biologic and genetic substances. This will help us look for genes or other substances that may be related to autism and child development.

Is this going to cost me anything?

There are no costs associated with the study.

Will I receive anything?

You will receive up to $315 to thank you for your participation and to cover out of pocket expenses such as travel. You do not have to wait until the end of the study to receive this. A portion of the $315 will be given to you after each main step in the study.

You will also receive the written results of the developmental examination of your child. We encourage you to share these with your health care provider.

Will the information I give be kept private?

Your study data will be stored in a database at Michigan State University. The information you give will only be used for this study. Your information will remain confidential unless otherwise required by law. We will never use your name or your child’s name in any report. The information you give will always be combined with information from all other participants.

You will be given a study ID. This study ID will be the only information on all study forms. Your name or other identifying information will not be on the study forms. Only people working on the study will have access to your personal information. Results from the study will only be linked to your study ID, not your name. This link will be maintained on a database that is kept on a secure computer (password protected) in the study manager’s office. If a hardcopy list is printed linking your ID and identifiers this will kept in a locked file cabinet in the study manager’s office.

Your biologic sample will be stored at the study lab at Johns Hopkins University. The people working on the study at the lab will enter and store your biologic sample. You can choose to store your biologic sample with or without a link to your name. Please see the form entitled ‘frequently asked questions about biologic samples’ for details of what this means.

Consent forms will be kept in locked file cabinets. Only a few specific study staff will have access to your consent forms.

We will eventually share some study data with other researchers. They will be approved by our team. We will not give them any information that could identify you. Other researchers will not have access to the list that links your study ID with your name.

Because sensitive information is collected in this study, <site> received a ‘Certificate of Confidentiality.’ This means that any information that <site> has that identifies you or your child will be used only for this project. It cannot be given to anyone else unless you give your written consent.

Will I be told about the results of the study?

You will get a letter about the results of your child’s developmental evaluation. You should get this letter within 3 months of the clinic visit. The letter will explain each test your child was given. It will explain your child’s scores on each test. It will tell you if your child performs at the same level as most children his/her age. It will also tell you if your child has any social, communication, or other delays. You will not receive a diagnosis. We are not giving diagnoses because the evaluation is part of a research study and is not given in order to get services or treatments.

You may learn that your child is performing below average in certain areas. If this happens, you can speak with a study representative to get information on developmental specialists located in your area.

<Site specific… You will be contacted by study staff if your child’s diet or stool record shows any concerns. Study staff will explain the results in detail. They will also refer you to a local physician for further follow-up.>

Little is known about which genes and other biologic substances are related to autism. The results from this study will only be initial leads. The same findings will have to be seen again in other studies before they can be considered useful to a particular child or family. Also, the labs that do our tests are research labs. These labs are not always approved for doing tests that are normally done on clinical patients. Because of these reasons, you will not receive individual results from the biological samples that we collect for this study.

 

We will send you a study newsletter up to two times per year. It will be mailed directly to your home. It will tell you general study results including genetic and lab results. You can discuss any of these findings with your medical provider. It is important to remember that it will be some time (up to several years) before all results are available.

Do I have to be in the study?

Your decision to be in the study is up to you. Your participation is voluntary. There is no penalty if you do not want to be in the study. Your child’s school and healthcare services will not be affected if you decide not to be in the study. You can drop out of the study at any time.

Certificate of Confidentiality

All answers that you give will be kept private. This is so because this study has been given a Certificate of Confidentiality. This means anything you tell us will not have to be given out to anyone, even if a court orders us to do so, unless you say it’s okay. But under law, we must report to the state suspected cases of child abuse or if you tell us you are planning to cause serious harm to yourself or others.

Who can I call if I have questions?

If you have questions about the study you can call <PI or project coordinator> at <phone number>.

If you feel you have been harmed by participating in this research study, please contact << PI or Project Coordinator>> at <insert phone number>.

If you have questions about your rights as a research participant you can call <name of local IRB contact> at <number at local IRB contact>.

Other Permissions

Permission to videotape the child developmental evaluation

□ I AGREE to have my child’s developmental evaluation videotaped.

I understand that the tapes will be used to record certain behaviors. The tapes will also be used to make sure that the person giving the tests is doing a good job. All tapes will be stored in locked areas.

□ I DO NOT WANT my child’s developmental evaluation videotaped.

Permission to take photographs of the child during the physical examination.

□ I AGREE to have my child photographed during the physical examination.

I understand that the photos will be used by a doctor to look for certain conditions. All photos will be stored in locked areas.

□ I DO NOT WANT my child photographed.

Permission to contact family for future studies

We would like to ask you to allow us to contact you for future studies. If you agree, you will allow us to contact you by mail or telephone to ask your permission to be in another study. These studies would be related to developmental disabilities. These studies may include biologic testing for genetic research.

□ I AGREE to be contacted for future research studies.

□ I DO NOT WANT to be contacted for future research studies.

Permission to link your information in future studies

In the future, researchers may want to link the information we collect about you with other data sets. If you agree, future researchers may link your data with other data sets. We will not contact you again or ask you to give use more information for these linkages.

□ I AGREE to allow my information to be linked in future research studies.

□ I DO NOT WANT my information to be linked in future research studies.

Permission to store biologic samples for future research

*PLEASE READ BIOLOGIC SAMPLES INFORMATION FORM BEFORE COMPLETING THIS SECTION!

Mother biologic samples (cheek cells, blood, DNA extracted)

□ I AGREE to have my biologic samples stored for future research studies (WITH identifiers – you may be contacted for future studies)

□ I AGREE to have my biologic samples stored for future research studies (WITHOUT identifiers – you will not be contacted for future studies)

□ I DO NOT WANT my biologic samples stored for future research studies (samples will be destroyed after the study is over)

Child biologic samples (cheek cells, blood, DNA extracted)

□ I AGREE to have my child’s biologic samples stored for future research studies (WITH identifiers – you may be contacted for future studies)

□ I AGREE to have my child’s biologic samples stored for future research studies (WITHOUT identifiers – you will not be contacted for future studies)

□ I DO NOT WANT my child’s biologic samples stored for future research studies (samples will be destroyed after the study is over)

Informed Consent Statement:

Permission to Enroll Child:

I have been told about the study. I know what is expected of my child. I was allowed to ask questions. I had all my questions answered. I give permission to enroll my child in this study.

_________________________________ ____________________

Signature of mother/legal guardian Date

_________________________________

Printed name (Mother/legal guardian)

_________________________________

Printed name (Child)

Permission to Enroll Self:

I have been told about the study. I know what is expected of me. I was allowed to ask questions. I had all my questions answered. I voluntarily agree to enroll in this study.

_________________________________ ____________________

Signature of mother/legal guardian Date

_________________________________

Printed name (Mother/legal guardian)

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