[Code of Federal Regulations]

[Title 34, Volume 1]

[Revised as of July 1, 2005]

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))