[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: 34CFR97.406]

[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. 97.406  Research involving greater than minimal risk and no prospect 

of direct benefit to individual subjects, but likely to yield generalizable 
knowledge 
          about the subject's disorder or condition.

    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 does not hold out the prospect of direct benefit for the individual 
subject, or by a monitoring procedure which is not likely to contribute 
to the well-being of the subject, only if the IRB finds that--
    (a) The risk represents a minor increase over minimal risk;
    (b) The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their actual or 
expected medical, dental, psychological, social, or educational 
situations;
    (c) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition that is of vital 
importance for the understanding or amelioration of the subjects' 
disorder or condition; and
    (d) Adequate provisions are made for soliciting 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))