PI name Page 3 of 3
Assent for MSI & HD-EEG in Clinical & Cognitive Neuroscience
TEXT TEMPLATE FOR CHILDREN ASSENT FORM
Investigational study: the use of magnetic source imaging and high density electroencephalography in clinical and cognitive neuroscience
PURPOSE OF RESEARCH
We are asking you be in a research study because we are trying to learn more about what the human brain does when a person touches, hears, smells, thinks, or speaks. From this study, we would like to create a better picture of the brain that shows how different parts of the brain are used when you hear a sound or see a picture, for example.
STUDY PROCEDURE
If you agree to be in this study, you will be asked to participate in several parts of testing, depending on how much time you and the scientists have and when the machines are available. All parts of the study are non-invasive, which means that they will occur outside of your body. There are no known risks. There are three major parts to this study.
1. You and/or your parent will be asked to answer some questions about your medical history. For example, we may ask you whether you have ever passed out from a head injury or if you have ever been diagnosed with a learning disorder. This will take about an hour. Also, it is possible that you will also be asked to take one or more exams for us to get a better idea of how you understand speech, how you see, etc. For example, if you have had some challenges with reading, we may ask you to take an exam that tests how you understand spoken words with noise in the background. This would probably take from one to two hours, with each test lasting about 30 minutes. You would be urged to do your best but you should not worry about being “graded” like in school.
2. The second part of the study involves recording the brain’s activity while we ask you to look at a picture, listen to a sound, or do other simple tasks. Just like a plug you stick into an outlet carries electricity, small paths in your brain carry electrical signals from one place to another. Two methods called HD-EEG and MEG measure the effects that this electrical activity has on or near the surface of your head. In this study, we will use one or both of these methods to measure your brain activity. None of this should be painful to you. If you feel any discomfort, you will be able to tell someone at any time and you should feel free to do so. You won’t make anyone mad if you want to stop.
We will take both MEG and HD-EEG measurements at the same time. In order to do the MEG and HD-EEG parts, you will wear a cap on your head. This cap has many small, smooth pieces of metal (called electrodes) that will rest on your head. They are not painful. To make the electrodes work better, your scalp under each electrode will be rubbed with a sandy paste. This rubbing may cause a little discomfort that would last less than a few minutes. The paste can be washed out of your hair easily with shampoo. More electrodes may be placed on your ears, both above and below your eyes, and on your chest. Four wire coils will also be pasted to your scalp. Sometimes removing these may pull your hair a little, which may be a little uncomfortable.
The device that records MEG and HD-EEG is located within the same sensor unit. During the testing, you will be seated with your head resting inside the sensor unit, which will feel like wearing a football helmet. You will need to try not to blink your eyes during the measurements. The session will last up to 3½ hours. This time includes about 50 minutes of time to get ready. During the testing, you will be given a break every fifteen minutes during which you will be able to walk around, go to the bathroom, etc.
3. For the third part of the study, we will record a MRI (magnetic resonance image) of your brain. This will take from 45 minutes to an hour. You will need to lie on your back with your head in a large, hooplike magnet. Your ears will be plugged to protect them from the loud noises made by the magnet.
During parts 2 and 3, there will be times when you will be asked to sit quietly with your eyes open or closed, to speak, or to move. At other times, we may ask you to touch or feel, listen, smell, look or just think about something. None of this should hurt or harm you in any way. At any point, you can tell us that you don’t want to be in the study after all. We understand, and you should also understand, that it’s entirely up to you whether you do this study. You may decide to quit at any time and without giving any reason; no one will be angry if you decide you don’t want to do it.
RISKS
There are no known risks for the first two parts of this study. The only known risk associated with MRI (part 3) is due to magnetic materials that are already in your body. You must tell us if you have anything that has been put inside of your body; for example, if you had a surgery and the doctor put a metal clip or plate inside of you, you would need to tell us that. We will also ask your parent to tell us this information, in case you don’t know. You may find it uncomfortable to hold your head still or to avoid blinking for long periods of time. As mentioned above, you will receive breaks every 15 minutes during part 2 (MEG/HD-EEG) of the study.
People who feel very uncomfortable in small spaces (this is called claustrophobia) might find the MRI too uncomfortable. If you think that you will begin to or (at any time during the exam) are beginning to feel this uncomfortable or scared feeling from being within the small space of the MR machine, you will have other choices. These include not doing the MRI exam or traveling about 10 miles to an open MRI system designed for people with claustrophobia.
If you have any questions regarding the procedures or the studies, please ask PI name, Co-PI name.
BENEFITS
Upon request, all imaging data and test results will be made available to you or your doctor. Your involvement in this study will help us to better understand how the brain works, and humanity may benefit if the studies lead to information that helps us to better understand and treat brain-related problems. You may expect no direct personal benefit from this research.
ALTERNATIVE PROCEDURES AND VOLUNTARY PARTICIPATION
If you don’t want to be in this study, you don’t have to participate. Remember, being in this study is up to you and no one will be upset if you don’t want to participate or even if you change your mind later and want to stop. Please talk this over with your parents before you decide whether to participate. We will also ask your parents to give their permission for you to take part in this study. But even if your parents say “yes” you can still decide not to do this.
CONFIDENTIALITY
Any information about you obtained from this research will be kept strictly confidential so that no one else can see it. Your research records, just like hospital records, may be subpoenaed by Court Order. By signing this document, you agree that it’s okay if the project investigators review the data they get if you participate and also that it’s okay if this data is used in publications such as journal articles or posters at scientific meetings. For publications, we will not reveal your name but may describe you in terms of age and gender or other general terms so that you can’t be identified.
PERSON TO CONTACT
You can ask any questions that you have about the study. If you have a question later that you didn’t think of now, you can call PI name at his office (801-xxx-xxxx) or on his cell phone (801-xxx-xxxx). You can also ask next time if you’d like. Signing your name at the bottom means that you agree to be in this study and that it’s okay with you if we share medical information learned from this study with your doctor. You and your parents will be given a copy of this form after you have signed it.