[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: 45CFR46.108]



[Page 121]

 

                        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. 46.108  IRB functions and operations.



    In order to fulfill the requirements of this policy each IRB shall:

    (a) Follow written procedures in the same detail as described in 

Sec. 46.103(b)(4) and, to the extent required by, Sec. 46.103(b)(5).

    (b) Except when an expedited review procedure is used (see Sec. 

46.110), review proposed research at convened meetings at which a 

majority of the members of the IRB are present, including at least one 

member whose primary concerns are in nonscientific areas. In order for 

the research to be approved, it shall receive the approval of a majority 

of those members present at the meeting.