Study Title: Clinical Markers Associated with Sudden Unexpected Death in Epilepsy in Dravet Syndrome.
Study Doctor/Researcher: Linda Laux, MD, Miriam Melissa Baltuano Songhurst, MD
This form describes a research study for which you might qualify. Research studies help us learn more about conditions and develop new treatments. Taking part in a research study is voluntary.
You are being asked to take part in this study because you are a member of the Dravet Syndrome Foundation and you and your child meet the criteria to be involved in this study. This study will help us learn more about the characteristics of Dravet syndrome that are associated to higher risk of sudden unexpected death in epilepsy (SUDEP).
If you choose to be in the study, you will be asked to answer an online survey and upload your child's deidentified test reports to gather information regarding your child's demographic data, characteristics of his/her condition such age of onset of seizures, seizure frequency and type, seizure control, treatment, prolonged seizures, genetic diagnosis and overall health and cognitive function. If you child has passed away from SUDEP, we would ask you to answer questions regarding your child's passing. The researchers will make every effort to keep the information collected from you and your child private. In order to do so, we are asking for deidentified reports to be uploaded. In the event this is not possible or difficult for you to do, we will remove any identifying information before analyzing the data.
We estimate that about 300 participants will take part in this study. Your participation will last about 40 minutes, which is approximately the time it takes to complete the study survey.
Being in this study is optional and voluntary. You do not have to take part in this study if you do not want to. You may change your mind at any time and withdraw ('take back' your consent) from taking part.
No intervention will be made to you or your child by participating in the study. However, there are some associated risks with participating in this study such as loss of confidentiality. Although your response will be anonymous and you have not been asked to provide any identifying information, your responses will be used for research purposes. In order to ensure confidentiality and protect you and your child's information, the information provided will be collected and stored in a secure online data management system. Data analysis conducted on the survey responses will only be done using a password protected encrypted computer. Data will be stored for five years after the completion of the study.
There is a small chance that some of the questions may make you feel uncomfortable or may be triggering, especially if your child has developed SUDEP. You may skip any questions you don't want to answer and may stop answering the study survey altogether at any point. If you need further support, the Dravet Syndrome Foundation Bereavement group and support will be available to you.
There will be no direct benefit to your child if you decide to participate in the study and complete the research questionnaire. However, there is a possibility that this study may find a link between certain characteristics and the risk of SUDEP in Dravet syndrome. If so, these findings will be shared with the Dravet Syndrome Foundation and passed on to the foundation's members (including you, if you remain a member) and this information may be used in the future to educate parents about the risk of SUDEP in Dravet syndrome
You will not be paid for taking part in this study.
We will tell you if we learn new information that may make you change your mind about being in this study.
The data collected for this study will be placed the Principal Investigator's research file. The principal investigator, co-investigators, Lurie Children's doctors who are involved in the study and the staff who work on the study, such as study nurses and coordinators, will have access to the study results. The Lurie Children's Institutional Review Board, the committee that is in charge of protecting the rights of all adults and children who take part in research studies at Lurie Children's, and federal agencies may have access to this information.
Lurie Children's and the researchers will keep the records of this study confidential and will release your/your child's medical information only to the people, agencies, organizations, or companies above. However, you should understand that, once the researchers or Lurie Children's releases your/your child's medical information outside of Lurie Children's to these people, agencies, organizations, or companies, the researchers and Lurie Children's cannot guarantee that your/your child's information will remain confidential.
The records of this study will be kept confidential with respect to any written or oral reports to the profession or the media, making it impossible to identify you/your child individually.
You are not giving up any of your or your child's legal rights or releasing this hospital from responsibility for carelessness. If you agree to take part in this study, you will not be able to look at or ask for a copy of your or your child's information collected only for this study, while you are taking part in the study. If you wish, you will be able to ask for this study research information when the study is over or when you are no longer taking part in the study. This does not affect your right to see your child's medical record or the results of tests related to regular medical care that is given during the same time as the research study.
Your permission to use your and your child's health information for this study will not expire unless you tell the researchers you want to cancel it.
If you have any questions about the research study, you should contact the investigators and research staff at sudepstudy@luriechildrens.org.
If you have questions about your child's rights or if you have a complaint, you can call the IRB Office at (312) 503-7110; or via email at IRB@luriechildrens.org.