Obtaining assent from children or youth as research participants means that the investigator is obtaining the agreement of the child to participate in the research. 另外, because children cannot legally give consent on their own behalf, consent of their parent(s) or a legal guardian also is required before children 和 youth can participate in research projects. Note: in the state of Nebraska consent 和 assent must be obtained for all subjects age 18 和 younger.
Obtaining Parental Consent
Follow these guidelines for obtaining parental consent for children as research subjects.
看到 Characteristics of Parental Consent 和 Sample Parental Consent Form for Non-Therapeutic Research.
Procedure for Obtaining 和 Documenting Assent
The means of obtaining assent from children must be appropriate for the age ranges 和 levels of mental development of the proposed subjects. The National Institutes of Health proposes the following guidelines:
Although age is used as the primary criteria to determine the appropriate procedure for obtaining assent, factors such as literacy 和 mental development must be considered. Because a single procedure for obtaining assent may not be appropriate for all potential subjects, investigators should be prepared to use different approaches with different participants.
The primary goal of assent is that the participant is able to underst和 explanation of the study as presented. The requirement for a witness to document verbal assent procedures depends on the complexity of the research 和 risks to the potential subjects.
A parent or guardian may not be the witness for a child’s verbal assent document. A child’s deliberate objection should be regarded as a veto of their involvement in the research.
检查 Characteristics for Obtaining Child/Youth Assent 和 Consent/Assent 检查表 before submitting protocol to the IRB.
看到 Sample Child Assent Form for Non-Therapeutic Research 和 Sample Youth Form for Non-Therapeutic Research.