[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR50.55]



[Page 288-289]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 50_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart D_Additional Safeguards for Children in Clinical Investigations

 

Sec.  50.55  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 D, the IRB must 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.

    (b) In determining whether children are capable of providing assent, 

the IRB must 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 clinical investigations under a particular 

protocol, or for each child, as the IRB deems appropriate.

    (c) The assent of the children is not a necessary condition for 

proceeding with the clinical investigation if the IRB determines:

    (1) That the capability of some or all of the children is so limited 

that they cannot reasonably be consulted, or

    (2) That the intervention or procedure involved in the clinical 

investigation 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 clinical investigation.

    (d) Even where the IRB determines that the subjects are capable of 

assenting, the IRB may still waive the assent requirement if it finds 

and documents that:

    (1) The clinical investigation involves no more than minimal risk to 

the subjects;

    (2) The waiver will not adversely affect the rights and welfare of 

the subjects;

    (3) The clinical investigation could not practicably be carried out 

without the waiver; and

    (4) Whenever appropriate, the subjects will be provided with 

additional pertinent information after participation.

    (e) In addition to the determinations required under other 

applicable sections of this subpart D, the IRB must determine that the 

permission of each child's parents or guardian is granted.

    (1) Where parental permission is to be obtained, the IRB may find 

that the permission of one parent is sufficient, if consistent with 

State law, for clinical investigations to be conducted under Sec.  50.51 

or Sec.  50.52.

    (2) Where clinical investigations are covered by Sec.  50.53 or 

Sec.  50.54 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 if consistent 

with State law.



[[Page 289]]



    (f) Permission by parents or guardians must be documented in 

accordance with and to the extent required by Sec.  50.27.

    (g) When the IRB determines that assent is required, it must also 

determine whether and how assent must be documented.