[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: 45CFR46.405]



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



    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 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. 46.408.