[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: 45CFR46.407]



[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. 46.407  Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or 

          welfare of children.



    HHS will conduct or fund research that the IRB does not believe 

meets the requirements of Sec. 46.404, Sec. 46.405, or Sec. 46.406 

only if:

    (a) The IRB finds that the research presents a reasonable 

opportunity to further the understanding, prevention, or alleviation of 

a serious problem affecting the health or welfare of children; and

    (b) The Secretary, after consultation with a panel of experts in 

pertinent disciplines (for example: science, medicine, education, 

ethics, law) and following opportunity for public review and comment, 

has determined either:

    (1) That the research in fact satisfies the conditions of Sec. 

46.404, Sec. 46.405, or Sec. 46.406, as applicable, or

    (2) The following:

    (i) The research presents a reasonable opportunity to further the 

understanding, prevention, or alleviation of a serious problem affecting 

the health or welfare of children;

    (ii) The research will be conducted in accordance with sound ethical 

principles;

    (iii) Adequate provisions are made for soliciting the assent of 

children and the permission of their parents or guardians, as set forth 

in Sec. 46.408.



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