SOLUTIONS IRB: THE SOLUTION FOR INDEPENDENT RESEARCHERS
SOLUTIONS IRB IRB Use Only IRB Study # CHILD ASSENT CHECKLIST Version 1.0
Protocol Name: Investigator: Primary Contact: For nonexempt studies including children, submit this checklist with the application for IRB approval. Attach all assent documents (written assent forms and/or scripts for oral assent). When appropriate child assent should be obtained by means of a written form that the child signs, given the child’s age and abilities. (To facilitate the child’s attention to and comprehension of the form, the researcher or research assistant(s) may read it aloud while the child reads silently.) If written assent is not appropriate, an oral assent procedure may be used, unless the child is too young to give assent. To comply with federal guidelines children should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if he or she agrees to participate. The child should then be asked whether or not he or she wishes to participate in the research.
Government Regulations [45 CFR 46.408 (b)] The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent.
CAPACITY FOR ASSENT Specify the anticipated age range of the children to be enrolled in the study.
Specify the portion of enrolled children expected to have the capacity to provide assent. All. Some, but not all. Specify which children will and which will not be capable of providing assent and why.
None. Explain why the children lack the capacity to provide assent.
Solutions IRB: Private Institutional Review Board for SBER researchers www.solutionsIRB.com
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Government Regulations [45 CFR 46.408 (a), 45 CFR 46.116 (d-e)] An IRB can waive the requirement for assent only if the following requirements are met: 1. The research involves no more than minimal risk to the participants. AND 2. The waiver will not adversely affect the rights and welfare of the participants. AND 3. The research could not practicably be carried out without the waiver. AND 4. Whenever appropriate, the participants will be provided with additional pertinent information after participation.
METHOD OF ASSENT For children capable of assent, how will assent be obtained? Written Assent Submit Assent Form. Oral Assent Submit Assent Script. Waiver of Assent is Requested If a waiver is requested for children capable of assenting, justify this request. Assent is required if children are capable of giving it, unless the criteria listed above for waiver are met.
Solutions IRB: Private Institutional Review Board for SBER researchers www.solutionsIRB.com
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