[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: 34CFR97.407]

[Page 312]
 
                           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. 97.407  Research not otherwise approvable which presents an opportunity 

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

    ED conducts or funds research that the IRB does not believe meets 
the requirements of Sec. 97.404, Sec. 97.405, or Sec. 97.406 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
    (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 that--
    (1) The research in fact satisfies the conditions of Sec. 97.404, 
Sec. 97.405, or Sec. 97.406, as applicable; or
    (2)(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; and
    (iii) Adequate provisions are made for soliciting the assent of 
children and the permission of their parents or guardians, as set forth 
in Sec. 97.408.

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