[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR50.55]

[Page 287-288]
 
                        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 288]]

    (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.