[Code of Federal Regulations]

[Title 34, Volume 1]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 34CFR97.408]



[Page 312-313]

 

                           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



[[Page 313]]



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 

Sec. Sec. 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 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))