[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: 45CFR46.402]



[Page 131]

 

                        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. 46.402  Definitions.



    The definitions in Sec. 46.102 of Subpart A shall be applicable to 

this subpart as well. In addition, as used in 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.



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