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Approval Date monthname dd, yyyy

2018-04-18 4页 doc 18KB 18阅读

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Approval Date monthname dd, yyyyApproval Date monthname dd, yyyy Stanford University Assent (For ages 17 and under) Approval Date: monthname dd, yyyy Generally, a child 7 – 17 years of age should sign an assent form. , Instructional text is in red and should be removed prior to submission to ...
Approval Date monthname dd, yyyy
Approval Date monthname dd, yyyy Stanford University Assent (For ages 17 and under) Approval Date: monthname dd, yyyy Generally, a child 7 – 17 years of age should sign an assent form. , Instructional text is in red and should be removed prior to submission to the IRB. , Red text in parentheses ( ) should be replaced by information for your study e.g., (your name here) , Elements may be removed at the Protocol Director's discretion. , Consider using large font if you anticipate recruiting participants with visual impairments, or for eye studies Study Title: 1. What will happen to me in this study? Description of the study: Explain the reason for the research. Describe what the child will be expected to do. Describe which part of the study is experimental. Describe all procedures using simple terms and explain any medical terms. 2. Can anything bad happen to me? Risks or Discomforts of Participating: Explain any possible risks to the child, using simple terms. If something might be painful, state this in the assent. Explain that the child should inform his/her parents if they are sick or in pain as a result of being in the study. 3. Can anything good happen to me? Benefits of Participating: Only describe known benefits to the child. You may include any possible future benefits to others. If there are no known benefits, state so. 4. Do I have other choices? Appropriate Alternatives: Describe any alternative procedures that might be available to the child other than this study. If none, this section can be omitted. 5. Will anyone know I am in the study? Confidentiality: Explain in simple terms that the child’s participation in the study will be kept secret, but information about him/her will be given to the study sponsor. Note: This information may not be applicable in assent forms for very young children. su_assent rev 01/07/15 Page 1 of 2 Stanford University Assent (For ages 17 and under) 6. What happens if I get hurt? Compensation for Participation/Medical Treatment: Describe that the child’s parents/legal guardians have been given information on what to do if the child is injured during the study. 7. Who can I talk to about the study? Contact Information: List people the child can contact if he/she has any questions or problems related to the study, for example: If you have any questions about the study or any problems to do with the study you can contact the Protocol Director (name of Protocol Director). You can call him/her at (Protocol Director’s phone number). You can also call (name) at (phone number). Keep the following sentence in exactly as written: If you have questions about the study but want to talk to someone else who is not a part of the study, you can call the Stanford Institutional Review Board (IRB) at (650)-723-5244 or toll free at 1-866-680-2906. 8. What if I do not want to do this? Voluntary Participation: Let the child know that they can stop being in the study at any time without getting in trouble and that their doctor will continue to treat them if treatment is necessary and available. SIGNATURE If you agree to be in this study, please sign here: ______________________________________ __________________ Signature of Child Date ______________________________________ Printed name of Child su_assent rev 01/07/15 Page 2 of 2
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