Principal Investigator: Marian J Rewers, MD, PhD
COMIRB No: 14-0553
Version Date: ______
Consent # ______
Study Title: Screening Consent for the Autoimmunity Screening for Kids (ASK) Program
You (you=your child) are being asked to be in a research study. This form provides you with information about the study. A member of the research team will describe this study to you and answer all of your questions. Please read the information below and ask questions about anything you don’t understand before deciding whether you want to participate.
Why is this study being done?
This study plans to learn more about the best way to screen all children for the early signs of childhood diabetes and celiac disease. Childhood (type 1) diabetes (T1D) is an autoimmune disease. It occurs when the immune system that normally protects the body from infection becomes confused and destroys the insulin producing cells in the pancreas. Insulin is necessary for the body to turn food into energy and to keep sugar at a normal level. Without insulin, a person develops diabetes. Celiac disease (CD) is also an autoimmune disease. It affects the small intestines where digested food is absorbed. People who have celiac disease get sick when they eat gluten, Gluten is found in wheat, oats, barley and rye. CD is treated by following a gluten-free diet.
You are being asked to be in this research study because you are between the ages of 1-17 years old, have presented at an ASK Screening site and live in the United States.
Other people in this study
Up to 70,000 children from the United States will participate in this study.
What happens if I join this study?
If you join the study, you will be asked for a sample of blood and be asked to complete a brief demographic questionnaire to help us understand your family history of type 1 diabetes and celiac disease.
You will be given a choice of either a blood draw or finger poke to obtain a small amount (up to 2ml) of blood. The blood sample will be used to test for the autoantibodies for T1D and CD. We will notify you by phone or mail with your test results.
If you test positive for any of the T1D or CD autoantibodies, we will ask you to come to the ASK Clinic at the Barbara Davis Center to have your blood tested a second time with a venipuncture. If you are unable to have your blood tested at the Barbara Davis Center, you will be referred to a local clinic or lab where you can have your blood drawn. We will draw up to 15.5 ml or 1.5 tablespoons of blood. If you are T1D autoantibody positive a random blood glucose and hemoglobin A1C will be done to make sure you do not have T1D at this visit. If you have a strong positive result for the T1D autoantibodies you will be asked to check your blood sugar periodically. We will provide you with your own glucometer for all glucose measurements. If we confirm the initial T1D test result we will offer you a follow- up study at the ASK Clinic. The follow-up study will include monitoring and education. Your participation is voluntary. You will be asked to sign a separate consent if you agree to the follow up study. If we confirm the initial CD result, we will provide you with the test results so you can share them with your doctor. Your doctor can send you to a gastroenterologist who may want to do more tests to see if you have celiac disease. The healthcare you receive from your primary care provider is not part of this study. We may offer you a single follow-up visit at the ASK clinic which is voluntary, with a separate consent. We may contact you in the future to ask you questions about celiac disease follow- up outcomes.
Some of your blood will be stored for future research to help us learn more about autoantibodies, metabolic markers for T1D, CD, genetic markers and other autoimmune diseases. You will be asked to sign a separate consent for any genetic marker testing done with your blood. The sample will not be labeled with your name or other information that could identify you.
To participate in this study you must understand and agree to the long-term storage of these samples. The samples cannot be withdrawn at any time in the future.
What are the possible discomforts or risks?
You may experience the discomfort of pain when the needle goes into the vein or the finger is poked. Before we take your blood from the vein, we can use a numbing spray to minimize the pain. The risk of more serious problems such as fainting, the temporary clotting of the vein, infection of the bruise or significant blood loss is much less than one in 1,000. Other risks may be that you are upset or worried if you have any of these autoantibodies for diabetes or celiac disease. However, most of the children in this study will not have positive results. We will fully explain the meaning of each test result. You may ask questions at any time. There is a risk that people outside of this research team will see your research information. We will do all that we can to protect your information, but it cannot be guaranteed. To protect you, we will keep all of the information about you in locked files. You will be given a specific study identifier so your name will not be used. The study may include risks that are unknown at this time.
What are the possible benefits of the study?
This study is designed for the researcher to develop and implement a general population screening program for two of the most frequent autoimmune diseases of childhood, T1D and CD. This screening program will serve as a demonstration project to assess the practical ways of screening for these conditions. The results will help identify children at risk for diabetes before the disease fully develops and may lead to an earlier diagnosis and earlier treatment. If you are found to be developing diabetes, we can watch you closely for early signs of the disease. Most children in this study will not get diabetes but they will still be a great help in determining how to best design a screening program. We will also tell you if you have an autoantibody for celiac disease. The results may help to find out if you need additional testing and should begin a gluten- free diet.
Who is paying for this study?
This research is being paid for by the JDRF International, the Helmsley Charitable Trust, and Janssen.
Will I be paid for being in the study?
You will not be paid for your participation in this study.
Will I have to pay for anything?
It will not cost you anything to be in the study. You will receive the results from this testing free of charge.
Is my participation voluntary?
Your participation in this study is voluntary. You have the right to choose not to take part in this study. If you choose to take part, you have the right to stop at any time. If you refuse or decide to withdraw later, you will not lose any benefits or rights to which you are entitled. It will not affect the relationship you have with your health care provider if you choose not to take part in this study.
Can I be removed from this study?
The study doctor may decide to stop your participation without your permission if he thinks that being in the study may cause you harm, or for any other reason. Also, the sponsor may stop the study at any time.
What happens if I am injured or hurt during the study?
If you have an injury while you are in this study, you should call Dr. Marian Rewers immediately. His phone number is 303.724.9787. We will arrange to get you medical care if you have an injury that is caused by this research. However, you or your insurance company will have to pay for that care.
Who do I call if I have questions?
The researcher carrying out this study is Dr. Marian Rewers. You may ask any questions you have now. If you have questions, concerns, or complaints later, you may call Cristy Geno, the Program Manager at 720- 207-1737 or the ASK Study at 303- 724- 1ASK. You may have questions about your rights as someone in this study. You can call Dr. Marian Rewers with questions. You can also call the responsible Institutional Review Board (COMIRB). You can call them at 303- 724-1055.
Who will see my research information?
The University of Colorado Denver (UCD) has 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 are:
• The Barbara Davis Center for Diabetes
• Children’s Hospital Colorado(CHCO)
• Denver Health
• Colorado School of Public Health
CHCO shares a medical record system with the Barbara Davis Center and PedsConnect; therefore, it is also possible that your information could be viewed by healthcare professionals at these organizations. It is possible that other healthcare professionals outside of the Barbara Davis Center and PedsConnect could view your information. 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 UCD and its affiliate hospitals may not be covered by this obligation. We will do everything we can to maintain the confidentiality of your personal information but confidentiality 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 Principal Investigator (PI), 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. Marian Rewers 1775 Aurora Ct. A140 Aurora, CO 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 this information, such as:
• Federal offices such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) that protect research subjects like you
• People at the Colorado Multiple Institutional Review Board (COMIRB)
• The study doctor and the rest of the study team
• The JDRF International, the Helmsley Charitable Trust, Janssen, and the sponsors of this research study
• Officials at the institution where the research is 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.
Information about you that will be seen collected, used and disclosed in this study:
• Demographic information (age, sex, ethnicity, history of T1D)
• Research visit and research test records
If you are screened at CHCO, the following Information about you will be disclosed in this study: Name, age, sex, address, phone number
What happens to data and blood that are collected in this study?
Scientists at the University of Colorado Denver (UCD) work to find the causes and cures of disease. The data and blood collected from you during this study are important to this study and to future research. If you join this study:
• The data and blood given by you to the investigators for this research no longer belong to you.
• Both the investigators and any sponsor of this research may study your data and blood collected from you.
• If data and blood are in a form that identifies you, UCD may use them for future research only with your consent or Institutional Review Board (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.
Agreement to be in this study and use my data
I have read this paper 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. I choose to be in this study. I will get a signed and dated copy of this consent form.
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