Shall require

subjects in the research is substituted, andthat the waiver is not inconsistent with Federal, State, or local law. The choice ofdepend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition. (d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of Subpart A. (e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented. §46.409 Wards. (a) Children who are wards of the State or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is: (1) related to their status as wards; or (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) If the research is approved under paragraph (a) of this sect