[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.408]

[Page 122]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 46--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
 Subpart D--Additional Protections for Children Involved as Subjects in 
                                Research
 
Sec. 46.408  Requirements for permission by parents or guardians and for assent by children.

    (a) In addition to the determinations required under other 
applicable sections of this subpart, the IRB shall determine that 
adequate provisions are made for soliciting the assent of the children, 
when in the judgment of the IRB the children are capable of providing 
assent. In determining whether children are capable of assenting, the 
IRB shall take into account the ages, maturity, and psychological state 
of the children involved. This judgment may be made for all children to 
be involved in research under a particular protocol, or for each child, 
as the IRB deems appropriate. If the IRB determines that the capability 
of some or all of the children is so limited that they cannot reasonably 
be consulted or that the intervention or procedure involved in the 
research holds out a prospect of direct benefit that is important to the 
health or well-being of the children and is available only in the 
context of the research, the assent of the children is not a necessary 
condition for proceeding with the research. Even where the IRB 
determines that the subjects are capable of assenting, the IRB may still 
waive the assent requirement under circumstances in which consent may be 
waived in accord with Sec. 46.116 of Subpart A.
    (b) In addition to the determinations required under other 
applicable sections of this subpart, the IRB shall determine, in 
accordance with and to the extent that consent is required by 
Sec. 46.116 of Subpart A, that adequate provisions are made for 
soliciting the permission of each child's parents or guardian. Where 
parental permission is to be obtained, the IRB may find that the 
permission of one parent is sufficient for research to be conducted 
under Sec. 46.404 or Sec. 46.405. Where research is covered by 
Secs. 46.406 and 46.407 and permission is to be obtained from parents, 
both parents must give their permission unless one parent is deceased, 
unknown, incompetent, or not reasonably available, or when only one 
parent has legal responsibility for the care and custody of the child.
    (c) In addition to the provisions for waiver contained in 
Sec. 46.116 of Subpart A, if the IRB determines that a research protocol 
is designed for conditions or for a subject population for which 
parental or guardian permission is not a reasonable requirement to 
protect the subjects (for example, neglected or abused children), it may 
waive the consent requirements in Subpart A of this part and paragraph 
(b) of this section, provided an appropriate mechanism for protecting 
the children who will participate as subjects in the research is 
substituted, and provided further that the waiver is not inconsistent 
with Federal, state or local law. The choice of an appropriate mechanism 
would depend 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 Sec. 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.