[Code of Federal Regulations]
[Title 34, Volume 1]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 34CFR97.408]

[Page 294-295]
 
                           TITLE 34--EDUCATION
 
PART 97--PROTECTION OF HUMAN SUBJECTS--Table of Contents
 
 Subpart D--Additional ED Protections for Children Who Are Subjects in 
                                Research
 
Sec. 97.408  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, 
if 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 if 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. 97.116.
    (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. 97.116, that adequate provisions are made for soliciting the 
permission of each child's parent(s) or guardian(s). If 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. 97.404 
or Sec. 97.405. If research is covered by Secs. 97.406 and 97.407 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 if 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. 97.116, 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 depends upon 
the nature

[[Page 295]]

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 must be documented in 
accordance with and to the extent required by Sec. 97.117.
    (e) If the IRB determines that assent is required, it shall also 
determine whether and how assent must be documented.

(Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-
1(b))