[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: 34CFR97.405]



[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))



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