[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: 45CFR46.120]



[Page 126]

 

                        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.  46.120  Evaluation and disposition of applications and proposals 

for research to be conducted or supported by a Federal Department or Agency.



    (a) The department or agency head will evaluate all applications and 

proposals involving human subjects submitted to the department or agency 

through such officers and employees of the department or agency and such 

experts and consultants as the department or agency head determines to 

be appropriate. This evaluation will take into consideration the risks 

to the subjects, the adequacy of protection against these risks, the 

potential benefits of the research to the subjects and others, and the 

importance of the knowledge gained or to be gained.

    (b) On the basis of this evaluation, the department or agency head 

may approve or disapprove the application or proposal, or enter into 

negotiations to develop an approvable one.