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\s20\widctlpar\adjustright \cf6\cgrid \sbasedon0 \snext20 Body Text 3;}}{\info{\title RESEARCH ASSENT FORM}{\author Johns Hopkins University}{\operator Johns Hopkins University}{\creatim\yr2004\mo4\dy12\hr13\min45}{\revtim\yr2004\mo4\dy12\hr13\min45}
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\par }\pard \s18\widctlpar\tqc\tx4320\tqr\tx8640\adjustright {Assent Form March 2004, Version 2
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REMOVE ALL THE INSTRUCTIONS IN RED BEFORE PRINTING
\par }\pard\plain \s20\widctlpar\adjustright \cf6\cgrid {\fs22 Assent Forms should NOT include section headings, HIPAA language, JHU boilerplate or signature page}{\f1\fs22 
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {\fs24 
\par }\pard\plain \s4\qc\keepn\widctlpar\outlinelevel3\adjustright \fs32\cgrid {RESEARCH ASSENT FORM}{\i\cf6 
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {\fs24\cf6 
\par }{\fs28 Protocol Title:
\par }\pard \qj\widctlpar\adjustright {\b\fs28 
\par }\pard \widctlpar\adjustright {\fs28 Application No.:
\par }{\b\fs28 
\par }{\fs28 Sponsor: }{\i\fs22\cf6 [delete if not applicable]}{\cf6 
\par }\pard \qc\widctlpar\adjustright {\b\fs28 
\par }\pard \widctlpar\adjustright {\fs28 Principal Investigator:
\par }{\b\fs28 
\par }\pard \widctlpar\brdrb\brdrs\brdrw30\brsp20 \adjustright {\fs28 Date:
\par }\pard \widctlpar\adjustright {\fs24 We want to tell you about a research study we are doing. A research study is a way to learn information about something. We would like to find out more about}{\fs24\cf6  }{\i\fs24\cf6 [insert purpose of study in}{
\b\fs24\cf6  }{\i\fs24\cf6 simple language].}{\b\fs24\cf6  }{\b\fs24  }{\fs24 You are being asked to join the study because  }{\i\fs24\cf6 [insert name of medical condition or other reasons for inclusion].
\par }{\fs24 
\par }\pard\plain \s1\keepn\widctlpar\outlinelevel0\adjustright \cgrid {If you agree to join this study, you will be asked to 
\par }\pard\plain \s19\widctlpar\adjustright \i\cf6\cgrid {[describe procedures, (e.g., blood work, questionnaires, medication) in words a child would know and understand. Also include number of visits and time frame in words easily understood by a child]. 

\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {\fs24 
\par }\pard\plain \s19\widctlpar\adjustright \i\cf6\cgrid {[describe possible risks, e.g., discomforts and/or side effects in simple language]. 
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {\b\fs24 
\par }\pard\plain \s16\widctlpar\adjustright \cgrid {We do not know if you will be helped by being in this study.  We may learn something that will help other children with }{\i\cf6 [insert name of medical condition or subject matter of stu}{\cf6 dy}{\i\cf6 ]}
{\b  }{some day. 
\par }\pard\plain \s1\keepn\widctlpar\outlinelevel0\adjustright \cgrid {\fs20 
\par }\pard \s1\widctlpar\outlinelevel0\adjustright {You do not have to join this study. It is up to you.  You can say okay now, and you can change your mind later.  All you have to do is tell us. No one will be mad at you if you change your mind. 
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {
\par }\pard\plain \s1\widctlpar\outlinelevel0\adjustright \cgrid {Before you say }{\b yes}{ to being in this study, we will answer any questions you have. 
\par }\pard \s1\keepn\widctlpar\outlinelevel0\adjustright {
\par If you want to be in this study, please sign your name. You will get a copy of this form to keep for yourself.
\par 
\par 
\par ________________________________________                                ___________________  
\par }\pard\plain \widctlpar\adjustright \fs20\cgrid {\fs24               (Sign your name here)\tab \tab \tab \tab \tab \tab        (Date)}{\caps\fs24 
\par }{\fs24 
\par 
\par }{\b\fs24 
\par }}