RADIANT Stage 1 Informed Consent Form
You ("you" means you or your child) are invited to participate in the Rare and Atypical Diabetes Network (RADIANT). RADIANT is a research study dedicated to identifying rare and unique forms of diabetes. We hope to discover new, rare, atypical forms of diabetes that are not like type 1 or type 2 diabetes. Individuals who may have a rare or atypical form of diabetes are invited to join this study.
This study has three stages. This consent is for Stage 1 of the study. If you agree to participate in Stage 1, you will be asked to complete a questionnaire about your medical history, diabetes diagnosis, and family history. You can complete the questionnaire online from home or anywhere you have access to the internet. Or, you can complete the questionnaire on paper instead. There are 5 sections in the questionnaire. The first section of the questionnaire may take you approximately 20 minutes to complete. Once you complete the first section, we will review your answers to see if you may qualify for further participation in the RADIANT study. If so, we will ask you to complete the rest of the questionnaire sections, which are about you, your physicians, your diabetes history, your medical history, and family history. It may take you approximately 2 hours to finish the questionnaire. You will be able to save and finish the questionnaire later if you cannot complete it all at one time.
A member of the research team may contact you to discuss the full study in more detail and they may also ask you for more information to help determine if you qualify to continue in the study. You will be able to ask any questions and choose if you want to continue to take part in the study.
If you qualify and agree to continue in the study, you will need to get approximately 3.5 mL (about 1 teaspoon) of your blood collected and shipped to the RADIANT laboratory for testing. You may be asked to have your blood collected at a lab or study center that will place a needle into a vein in your arm, or we may ask you to prick your fingertip to collect the blood. We will give you instructions on how to complete your blood collection. We may send you a blood collection kit. You will be tested for diabetes-related autoantibodies in the blood. Autoantibodies are proteins that are made by the body's immune system. If you would like to receive these results, the research team will share the results of the autoantibody test with you. We may recontact you to ask for additional blood samples. You can always say no. Reasons for a new sample might include that we have used up the first sample or that the sample did not pass a quality control check. If you are asked to complete the blood collection by pricking your fingertip and it is not possible to collect enough blood from your fingertip, you may be asked to repeat the blood collection by going to a lab or study center that will place a needle into a vein in your arm to collect the blood.
With your permission, we may also collect information from your medical records. Examples include results of tests, medical procedures, images (such as X-rays), and medicines you take. Researchers will use this information to better understand whether you have an atypical form of diabetes. We will ask you to sign a separate medical record release form. We will look at your medical record from time to time to update this information. This will take place for as long as you are in the study.
After you complete Stage 1, your information will be reviewed by a team of medical experts called the Adjudication Committee that will determine if you qualify to continue in the study. If you qualify to continue in the study, we may ask you to participate in Stage 2 and Stage 3 of the study. You may be asked to participate in these stages at the same time or at separate times. To participate in these stages of the study, you will be referred to a RADIANT study center to sign the informed consent form(s) and complete the procedures for each stage. Stage 2 and 3 procedures include: a visit to a RADIANT study center, collection of clinical information about you, collection of information about your family medical history, and collection of additional blood samples from you for laboratory and genetic testing. For Stage 2, you may be asked to go to a nearby lab (such as Quest Diagnostics) instead of a RADIANT study center, so the lab can collect your blood samples and ship them to us. For Stage 3, you will need to travel to a RADIANT study center. If you participate in all three stages of RADIANT, your participation may last for up to 3 years.
Participation in this study is voluntary. You do not have to participate in this study if you do not want to, and you can withdraw your participation at any time during the study. You will not lose any services, benefits or rights you would normally have if you choose not to volunteer.
Are there any risks to taking part in Stage 1 of the study?
When your blood is collected, you may feel brief pain or have some bruising from the needle. Infection, light-headedness, and fainting are also possible, but unlikely. We will do everything we can to keep your information private, but we cannot guarantee this. Study information will be kept in a secured manner and electronic records will be password protected. It is unlikely, but there is a chance that your information could be viewed by someone who is not authorized to see it. Some of the questions are personal and might make you feel uncomfortable. You may skip any questions that you do not want to answer.
As a part of this study, we will ask you to provide your email address so we can communicate with you about the study by email and set-up your RADIANT Participant Portal account. There is a risk that your email could be accessed by unauthorized users (i.e. other people without your permission, such as hackers) and they may be able to see information emailed to you. By agreeing to participate in this study, you are agreeing that you understand this inherent risk and that it is okay for RADIANT to email you.
Are there any benefits to taking part in Stage 1 of the study?
There is no guarantee that you will benefit from this study. If we learn any information on why you developed diabetes, we will share this information with you.
Other Studies in Which You May be Participating or May Wish to Participate
We would like to contact you for future research studies. A member of the RADIANT staff may send you information on other studies for which you may be eligible. You do not have to take part in other research studies.
Laboratory Test Results Sharing
A diabetes autoantibody test may be performed in Stage 1. You may choose whether you want us to share the results of these tests with you and with your healthcare provider. If you choose for RADIANT to share your results with your healthcare provider, your provider will likely include the results in your medical record.
Authorization to Use and Disclose Protected Health Information
The federal Health Insurance Portability & Accountability Act (HIPAA) protects your identifiable health information. By agreeing to participate in this study, you are permitting the RADIANT Data Coordinating Center at the University of South Florida (USF) to use your health information for research purposes. You are also allowing us to share your health information with individuals or organizations other than USF who are involved in the research and listed below. The following groups of people may see your health information that you provide us and may use it to conduct this research:
The medical staff that takes care of you and those who are part of this research study;
RADIANT research sites and study teams involved in this research;
The Data Coordinating Center;
Any laboratories or others who are part of the approved plan for this study;
The University of Utah Institutional Review Board (IRB) and its related staff who have oversight responsibilities for this study;
Observational Study Monitoring Boards or others who monitor the data and safety of the study;
There may be other people and/or organizations who may be given access to your personal health information, including the U.S. federal agency providing funds for this study, such as the U.S. National Institutes of Health (NIH).
Anyone listed above may use consultants in this research study, and may share your information with them. If you have questions about who they are, ask the study team. Individuals who receive your health information for this research may not be required by the HIPAA Privacy Rule to protect it and may share it with others without your permission. They can only do so if permitted by law. If your information is shared, it may no longer be protected by the HIPAA Privacy Rule.
As part of this research, USF may collect, use, and share the following information:
Your research record and results
Past and present medical records with your permission
Your date of birth
Your name and contact information
Records about your study visits and contact with your study team
You can refuse to allow the use and disclosure of your health information. If you do not allow the use and disclosure of your health information, you will not be able to take part in this research. However, your care outside of this study and benefits will not change. Your authorization to use your health information will not expire unless you revoke (withdraw) it in writing. You can revoke your authorization at any time by sending an email with the subject line 'Withdraw' to email@example.com and indicate in the email message that you wish to withdraw your authorization to use your health information in the research. If you revoke your authorization:
You will no longer be a participant in this research study;
We will stop collecting new information about you;
We will use the information collected prior to the revocation of your authorization. This information may already have been used or shared with others, or we may need it to complete and protect the validity of the research; and
Staff may need to follow-up with you if there is a medical reason to do so.
While we are conducting the research study, we cannot let you see or copy the research information we have about you. After the research is completed, you have a right to see the information about you. If you have any questions about the study, please contact:
The University of Utah Institutional Review Board (IRB) is serving as the single IRB for this study. Contact the IRB if you have questions regarding your rights as a research participant. Also, contact the IRB if you have questions, complaints or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at firstname.lastname@example.org.
Storage of Data in NIDDK/NIH Repository
Your study data and samples, without any information that could identify you, might be used for future research studies by us or other researchers without additional informed consent from you or your legally authorized representative. When RADIANT is over, we intend to send any data we have collected to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) repository, as well as other NIH approved databases such as The Database of Genotypes and Phenotypes (dbGaP), for future studies. Data and samples will be stored there indefinitely without your name. You will not be able to withdraw your data and samples from the NIDDK/NIH Repository, because no one can identify which data and samples are yours. Researchers must first get permission from the NIDDK/NIH to use data from the repository. Because these researchers will not have access to your identity, neither you nor your health care provider will get the eventual results of other studies that might be performed using your sample/data.
We will use your blood sample only for research. We will not sell it. However, research results might someday lead to the development of a medical or genetic test, drug, or other commercial product. You will not receive money from the development or sale of any such product. If you are ready to participate in this study, you will need to complete the requested information below. If you agree to participate, a copy of the consent form will be emailed to you.
Consent survey was completed on paper:
Date informed consent signed by participant:
Do you agree to participate in this research study?
must provide value Yes No
Study Participant's Date of Birth:
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Please select a valid date.
I confirm that I am the study participant and 18 years old or older, or that I am the parent/legal guardian of the study participant (if participant is under 18 years old, or if participant is 18 years old or older but unable to consent for themselves).
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Please confirm one of the following:
must provide value I am the study participant and 18 years old or older. I am the parent/legal guardian of the study participant and the study participant is under 18 years old I am the legal guardian of the study participant, the study participant is an adult (18 years or older) who is unable to consent for themselves, and I have the legal authority to make medical decisions for the study participant.
Name of Study Participant:
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Relationship to Participant:
Name of person filling out this consent form (if not the study participant):
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Street Address 1:
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Sharing Results With Me:
must provide value Yes, I would like you to share laboratory results with me*. I understand that these results will be shown in my Participant Portal account. No, I do not want to receive laboratory results. I understand that I may be refusing results that are clinically relevant.
Sharing Results With My Healthcare Provider:
must provide value Yes, I would like you to share my results with my healthcare provider. No, I do not want you to share results with my healthcare provider. I understand that if my healthcare provider is a part of RADIANT, my provider may still see my results as a part of their role in RADIANT.
Practice name/hospital name: