[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: 45CFR46.305]



[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. 46.305  Additional duties of the Institutional Review Boards where prisoners are involved.



    (a) In addition to all other responsibilities prescribed for 

Institutional Review Boards under this part, the Board shall review 

research covered by this subpart and approve such research only if it 

finds that:

    (1) The research under review represents one of the categories of 

research permissible under Sec. 46.306(a)(2);

    (2) Any possible advantages accruing to the prisoner through his or 

her participation in the research, when compared to the general living 

conditions, medical care, quality of food, amenities and opportunity for 

earnings in the prison, are not of such a magnitude that his or her 

ability to weigh the risks of the research against the value of such 

advantages in the limited choice environment of the prison is impaired;

    (3) The risks involved in the research are commensurate with risks 

that would be accepted by nonprisoner volunteers;

    (4) Procedures for the selection of subjects within the prison are 

fair to all prisoners and immune from arbitrary intervention by prison 

authorities or prisoners. Unless the principal investigator provides to 

the Board justification in writing for following some other procedures, 

control subjects must be selected randomly from the group of available 

prisoners who meet the characteristics needed for that particular 

research project;

    (5) The information is presented in language which is understandable 

to the subject population;

    (6) Adequate assurance exists that parole boards will not take into 

account a prisoner's participation in the research in making decisions 

regarding parole, and each prisoner is clearly informed in advance that 

participation in the research will have no effect on his or her parole; 

and

    (7) Where the Board finds there may be a need for follow-up 

examination or care of participants after the end of their 

participation, adequate provision has been made for such examination or 

care, taking into account the varying lengths of individual prisoners' 

sentences, and for informing participants of this fact.

    (b) The Board shall carry out such other duties as may be assigned 

by the Secretary.

    (c) The institution shall certify to the Secretary, in such form and 

manner as the Secretary may require, that the duties of the Board under 

this section have been fulfilled.