What should be covered in an assent process?
The regulations provide little guidance. The essential elements of the consent information should be provided, at a level and to the extent that the child is able to understand it. A lot of the formulaic elements (like compensation) can be omitted, but one should include: • What the subject is being asked to do, • What the risks are likely to be, • What benefits there might be, • That participation is entirely voluntary, • A statement of what the research is about.
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