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In general permission should be obtained from both parents before a child is enrolled in research However the Institutional Review Board IRB may find that the permission of one parent is sufficient for research to be conducted under 46404 or 46405.

The law authorizes parents or guardians of a minor anyone under the age of 1 to give informed consent for most medical decisions on behalf of the child.

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When research is conducted with minors informed consent must generally be sought and documented from a parentguardian in the case of a minor Legally.

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The Informed Consent Form ICF is the main source of information to those considering participation in a clinical research study and is used to document a.

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This poses a problem for researchers who wish enrol such minors as participants in research projects because currently there is no clear guidance regarding.

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Thus in most research studies if children under the age of 1 are to be enrolled the parent or guardian of the child must provide informed consent on behalf of the child.

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Or as little information about proposed clinical research studies as adults do.

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Or distributed for future research studies even if your identifiable information is removed.

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Template and Examples for Informed Consent when human subjects are minors Exhibit F Template for Parental Permission Letter Exhibit G Example Parental.

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Emancipated and Mature Minors It makes clear that most states have no explicit provisions about a minor's agreement to participation in research without parental consent.

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The manufacturer of the test article usually has a sample Informed Consent form.

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