Template Version 1.5, 2/14/2019 GENERAL INSTRUCTIONS delete this box from the submitted consent form – This template is for obtaining consent and authorization for continued follow-up and further collection of Protected Health Information from adult subjects who withdraw from a study (called main study” in the instructions for this template). If the subjects are children, edit by changing “the to child” throughout the template. “you” “your Use this template as follows: Red text represents instructions to you to be deleted from the trial version. For example, – when a section starts with if…],” you should read the red bracketed phrase, and “[Include either delete the whole section if not applicable to your study, or delete just the red bracketed phrase and retain the section if applicable to your study. Blue text represents guidance on suggested content to be edited and changed to black or – replaced with black in the final version. The language should be understandable at an 8th grade reading level. Black text represents text that should ordinarily be incorporated as-is, if applicable. If necessary, change to child” throughout the black text “you” “your are two signature pages at the end of this template; use the one that is applicable and delete the other one. Please note that you must enter the project title and PI name in black in the header on the second page. The submitted version should have no red or blue text (including instruction boxes like this one) RESEARCH CONSENT FORM Information Title of Project: Title of main study Consent for Follow-Up – IRB Number: the number” of the main study “H [Include if there is one or more external sponsor; otherwise, delete paragraph] Sponsor: External sponsor(s). Principal Investigator: PI name PI/study email PI/study mailing address [Include A or B] [A. Include if the main study is no more than minimal risk; otherwise, delete paragraph] Study Phone Number: phone number
Template Version 1.5, 2/14/2019 GENERAL INSTRUCTIONS – delete this box from the submitted consent form This template is for obtaining consent and authorization for continued follow-up and further collection of Protected Health Information from adult subjects who withdraw from a study (called “the main study” in the instructions for this template). If the subjects are children, edit by changing “you” to “your child” throughout the template. Use this template as follows: Red text represents instructions to you – to be deleted from the version. For example, when a section starts with “[Include if…],” you should read the red bracketed phrase, and either delete the whole section if not applicable to your study, or delete just the red bracketed phrase and retain the section if applicable to your study. Blue text represents guidance on suggested content – to be edited and changed to black or replaced with black in the final version. The language should be understandable at an 8th grade reading level. Black text represents text that should ordinarily be incorporated as-is, if applicable. If necessary, change “you” to “your child” throughout the black text are two signature pages at the end of this template; use the one that is applicable and delete the other one. Please note that you must enter the project title and PI name in black in the header on the second page. The submitted version should have no red or blue text (including instruction boxes like this one) RESEARCH CONSENT FORM Information Title of Project: Title of main study – Consent for Follow-Up IRB Number: the “H number” of the main study [Include if there is one or more external sponsor; otherwise, delete paragraph] Sponsor: External sponsor(s). Principal Investigator: PI name PI/study email PI/study mailing address [Include A or B] [A. Include if the main study is no more than minimal risk; otherwise, delete paragraph] Study Phone Number: phone number trial