PERMISSION FORM (TEMPLATE VERSION: 11/27/17) **Note - only add the CTSI language if the study has been accepted by the CTSI. 12 IN NEW [all instructions (in RED) and text not applicable to the research should be deleted when the form is modified for use on a particular study] Guidelines: Use simple language 6th to 8th grade reading level. – Be concise. Use pronouns such as and consistently throughout (except for the “you” “your” of Research Subject” on the last page) as the person of address is the subject. “Signature Children’s Hospital Los Angeles PERMISSION TO PARTICIPATE A RESEARCH STUDY [Insert title of study] [If study title is technical, add lay language title] [If the study involves using different forms for different populations, identify the population group as a subtitle] Subject’s Name: Subject’s CHLA Subject’s medical record #[if Birth applicable]: Date: KEY INFORMATION [this section must come first and should include the highlights necessary for a lay person who doesn’t read beyond this section to make a reasonable decision about participation in the research. The entirety of this section should fit on the first page of this form.] The information in this form is being used to seek your consent for your child to be in a research study. The decision to allow your child to be in the study is up to you. This research is trial done to find out [keep to a single sentence, such as the best way “… to treat people with Cystic Fibrosis.” or teens think about drug use in their social “…how group.”]. Participation will last up to [indicate max time of participation, if a subject completes all procedures]. Study procedures for this research are: [briefly list all types of procedures in the research, but not the details on frequency or timing] [procedure: keep it general such as child will take a study medicine “Your every week by injection under the skin.”] [procedure: keep it general such as scan(s). If your child is not able to lie “CT still during the scan, they will get some medicine to help them sleep.”] [procedure: keep it general such as child will complete questionnaires “Your about their views on drug use in teens.”]
PERMISSION FORM (TEMPLATE VERSION: 11/27/17) **Note - only add the CTSI language if the study has been accepted by the CTSI. 12 [all instructions (in RED) and text not applicable to the research should be deleted when the form is modified for use on a particular study] Guidelines: Use simple language – 6th to 8th grade reading level. Be concise. Use pronouns such as “you” and “your” consistently throughout (except for the “Signature of Research Subject” on the last page) as the person of address is the subject. Children’s Hospital Los Angeles PERMISSION TO PARTICIPATE IN A RESEARCH STUDY [Insert title of study] [If study title is technical, add lay language title] [If the study involves using different forms for different populations, identify the population group as a subtitle] Subject’s Name: Subject’s CHLA medical record #[if applicable]: Subject’s Birth Date: KEY INFORMATION [this section must come first and should include the highlights necessary for a lay person who doesn’t read beyond this section to make a reasonable decision about participation in the research. The entirety of this section should fit on the first page of this form.] The information in this form is being used to seek your consent for your child to be in a research study. The decision to allow your child to be in the study is up to you. This research is done to find out [keep to a single sentence, such as “… the best way to treat people with Cystic Fibrosis.” or “…how teens think about drug use in their social group.”]. Participation will last up to [indicate max time of participation, if a subject completes all procedures]. Study procedures for this research are: [briefly list all types of procedures in the research, but not the details on frequency or timing] [procedure: keep it general such as “Your child will take a study medicine every week by injection under the skin.”] [procedure: keep it general such as “CT scan(s). If your child is not able to lie still during the scan, they will get some medicine to help them sleep.”] [procedure: keep it general such as “Your child will complete questionnaires about their views on drug use in teens.”] NEW trial
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