[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

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

[CITE: 45CFR46.119]



[Page 125]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart A_Basic HHS Policy for Protection of Human Research Subjects

 

Sec.  46.119  Research undertaken without the intention of involving human 

subjects.



    In the event research is undertaken without the intention of 

involving human subjects, but it is later proposed to involve human 

subjects in the research, the research shall first be reviewed and 

approved by an IRB, as provided in this policy, a certification 

submitted, by the institution, to the department or agency, and final 

approval given to the proposed change by the department or agency.



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