The following key points should be considered when authoring the statement of consent section.
- Add a signature space to document assent of children to participate
in the study. Parental signatures are still required.
- If the potential subject is not competent, use an assent document with
caregiver consent. Do not use a witness.
- If you use a witness line, it should clearly describe what the signer is witnessing, e.g., witness to signature.
- Give participant a copy.