[Code of Federal Regulations]

[Title 34, Volume 1]

[Revised as of July 1, 2006]

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))