[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.406]



[Page 132]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

 Subpart D_Additional Protections for Children Involved as Subjects in 

                                Research

 

Sec. 46.406  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.



    HHS will conduct or fund 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 which 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. 46.408.