ࡱ> WYV bjbj 4F}c}cF 8=D\.-------$/`2---hhhR-h-hh*h+>y v+k--0.%+"3"3 +" ,"3,Lh--h."3 : RESEARCH SUBJECT INFORMATION SHEET FOR Clinical Studies WITH ADOLESCENTS (Ages 15 17) GENERAL INSTRUCTIONS FOR USING THIS FORM: This template includes shaded boxes providing brief instructions. Other instructions are shaded or underlined and in parentheses. Delete all shaded and underlined instructional text in parentheses BEFORE submitting this form to the 91Ů IRB for review. To delete an instruction box, place your curser within the shaded box, right click the mouse, and select Delete Rows. To delete shaded or underlined text, select the text by highlighting with your mouse, and push the delete button on your keyboard. Customize the text in this information sheet to fit your study. Print this form on University letterhead. Instructions for the consent form header below: List all sites (under 91Ů IRB jurisdiction) in which the research study will take place below SAINT LOUIS UNIVERSITY. Insert the IRB # obtained from eIRB. The Title of Project should match the protocol title. This title should also match the sponsor contract or grant title if appropriate. SAINT LOUIS UNIVERSITY Participant: IRB #:First Name / Last NamePrincipal Investigator (PI)Contact Phone #First Name / Last Name CredentialsTitle of Project:  You are being asked to participate in a clinical research study. Your decision to be in this study is voluntary. You do not have to participate in this study if you do not want to. This information sheet will give you information about the risks and benefits of this study so that you can make a better decision about whether you want to take part or not. PURPOSE OF THE STUDY The purpose of this research study is (insert age-appropriate description of study purpose). You are being asked to be in this study because you have (insert condition). (Insert study drug/device/procedure) is approved for treating (insert condition) in adults but is not approved in adolescents or children. In this study, you will receive (insert study drug/procedure) for at least (insert # of weeks) weeks. After the study, you will be treated with (insert relevant treatment information). PROCEDURES You will be in this study for approximately (insert # of weeks) weeks. You will have (insert # of visits) visits. Procedures done during this study include a history and examination, blood tests at most visits, and (insert other procedures in age appropriate language). RISKS AND DISCOMFORTS Side effects reported with (insert study drug/device/procedure) have included (insert age-appropriate information on side effects). The risks of the blood draw include temporary discomfort from the needle in your arm, bruising, swelling at the needle site and, in rare instances, infection. Side effects of other study procedures include: (insert age-appropriate information on other side effects). Additional side effects that are unknown at this time could occur during treatment. (USE ONLY IF APPLICABLE. PICK APPROPRIATE OPTION AND REMOVE SHADING) Option 1: Use for studies involving drugs without known teratogenic effects (NOT Category x). The effects of (insert study drug/device/procedure) during pregnancy have not been fully studied. There might be unknown risks to the unborn child if you (your partner if you are male) become pregnant during this study. Due to these risks you must not be in this study if you become pregnant, plan to become pregnant during the research study, or are breast-feeding a child. You/your partner must not get pregnant during the study. If you are having sex, you must talk to your parents and doctor about how to make sure you/your partner do not get pregnant. Pregnancy testing will be done during the study. If your pregnancy test shows that you are pregnant, your parents or legal guardians will be told. Option 2: Use for studies involving drugs with known teratogenic effects (i.e. Category x). This template should be used for ages 10 and greater; change title and ages at top of form to Children (Ages 10-17). We know that (insert study drug name) can cause miscarriages or bad birth defects in babies. If you are a girl, it is VERY IMPORTANT that you do not get pregnant during the study (also include if time period after last dose). If you are a boy, it is VERY IMPORTANT that your partner does not get pregnant. You must use a condom (include other required barrier method details) if you have sex while you are in this study. The study doctor will talk to you about what other type(s) of birth control to use. Ask your parents or the study doctor if you have any questions about pregnancy risks. If you are a girl and have started your periods, pregnancy testing will be done. If your pregnancy test shows that you are pregnant, your parents or legal guardians will be told. You must not take part in this study if you become pregnant. If at any time you think you might be pregnant, you must tell your study doctor right away. POSSIBLE BENEFITS OF THE STUDY Your (insert condition) may improve, get worse, or stay the same as a result of your participation in this study. You may not experience any direct health benefits. Information from this study may lead to a better treatment in the future for adolescents and children with (insert condition). For further information about this study, please refer to the consent form discussed with your parent/guardian for this study. If you have any questions about this study, please ask your parents/guardian or call the study doctor, (insert study doctors name, e.g., Dr. Smith), or study nurse at (insert phone number). SAINT LOUIS UNIVERSITY INSTITUTIONAL REVIEW BOARD APPROVAL STAMP This form is valid only if the IRBs approval stamp is shown below.      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