[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

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

[CITE: 45CFR46.408]



[Page 133]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH 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 Sec. Sec. 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.