[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.407]

[Page 133-134]
 
                        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. 46.407  Research not otherwise approvable which presents an 

opportunity to understand, prevent, or alleviate a serious problem 
affecting the health or 
          welfare of children.

    HHS will conduct or fund research that the IRB does not believe 
meets the requirements of Sec. 46.404, Sec. 46.405, or Sec. 46.406 
only if:
    (a) The IRB finds that the research presents a reasonable 
opportunity to further the understanding, prevention, or alleviation of 
a serious problem affecting the health or welfare of children; and

[[Page 134]]

    (b) The Secretary, after consultation with a panel of experts in 
pertinent disciplines (for example: science, medicine, education, 
ethics, law) and following opportunity for public review and comment, 
has determined either:
    (1) That the research in fact satisfies the conditions of Sec. 
46.404, Sec. 46.405, or Sec. 46.406, as applicable, or
    (2) The following:
    (i) The research presents a reasonable opportunity to further the 
understanding, prevention, or alleviation of a serious problem affecting 
the health or welfare of children;
    (ii) The research will be conducted in accordance with sound ethical 
principles;
    (iii) Adequate provisions are made for soliciting the assent of 
children and the permission of their parents or guardians, as set forth 
in Sec. 46.408.