[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: 45CFR46.304]



[Page 130]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

Subpart C_Additional Protections Pertaining to Biomedical and Behavioral 

                Research Involving Prisoners as Subjects

 

Sec. 46.304  Composition of Institutional Review Boards where prisoners are involved.



    In addition to satisfying the requirements in Sec. 46.107 of this 

part, an Institutional Review Board, carrying out responsibilities under 

this part with respect to research covered by this subpart, shall also 

meet the following specific requirements:

    (a) A majority of the Board (exclusive of prisoner members) shall 

have no association with the prison(s) involved, apart from their 

membership on the Board.

    (b) At least one member of the Board shall be a prisoner, or a 

prisoner representative with appropriate background and experience to 

serve in that capacity, except that where a particular research project 

is reviewed by more than one Board only one Board need satisfy this 

requirement.



[43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8386, Jan. 26, 1981]