[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: 34CFR97.405]

[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. 97.405  Research involving greater than minimal risk but presenting 
the prospect of direct benefit to the individual subjects.

    ED conducts or funds research in which the IRB finds that more than 
minimal risk to children is presented by an intervention or procedure 
that holds out the prospect of direct benefit for the individual 
subject, or by a monitoring procedure that is likely to contribute to 
the subject's well-being, only if the IRB finds that--
    (a) The risk is justified by the anticipated benefit to the 
subjects;
    (b) The relation of the anticipated benefit to the risk is at least 
as favorable to the subjects as that presented by available alternative 
approaches; and
    (c) Adequate provisions are made for soliciting the assent of the 
children and 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))