[Code of Federal Regulations]
[Title 34, Volume 1]
[Revised as of July 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 34CFR97.402]

[Page 311]
 
                           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. 97.402  Definitions.

    The definitions in Sec. 97.102 apply to this subpart. In addition, 
the following definitions also apply to this subpart:
    (a) Children are persons who have not attained the legal age for 
consent to treatments or procedures involved in the research, under the 
applicable law of the jurisdiction in which the research will be 
conducted.
    (b) Assent means a child's affirmative agreement to participate in 
research. Mere failure to object should not, absent affirmative 
agreement, be construed as assent.
    (c) Permission means the agreement of parent(s) or guardian to the 
participation of their child or ward in research.
    (d) Parent means a child's biological or adoptive parent.
    (e) Guardian means an individual who is authorized under applicable 
State or local law to consent on behalf of a child to general medical 
care.

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