[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: 45CFR46.306]



[Page 130-131]

 

                        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.  46.306  Permitted research involving prisoners.



    (a) Biomedical or behavioral research conducted or supported by DHHS 

may involve prisoners as subjects only if:

    (1) The institution responsible for the conduct of the research has 

certified to the Secretary that the Institutional Review Board has 

approved the research under Sec.  46.305 of this subpart; and

    (2) In the judgment of the Secretary the proposed research involves 

solely the following:

    (i) Study of the possible causes, effects, and processes of 

incarceration, and of criminal behavior, provided that the study 

presents no more than minimal risk and no more than inconvenience to the 

subjects;

    (ii) Study of prisons as institutional structures or of prisoners as 

incarcerated persons, provided that the study



[[Page 131]]



presents no more than minimal risk and no more than inconvenience to the 

subjects;

    (iii) Research on conditions particularly affecting prisoners as a 

class (for example, vaccine trials and other research on hepatitis which 

is much more prevalent in prisons than elsewhere; and research on social 

and psychological problems such as alcoholism, drug addiction and sexual 

assaults) provided that the study may proceed only after the Secretary 

has consulted with appropriate experts including experts in penology 

medicine and ethics, and published notice, in the Federal Register, of 

his intent to approve such research; or

    (iv) Research on practices, both innovative and accepted, which have 

the intent and reasonable probability of improving the health or well-

being of the subject. In cases in which those studies require the 

assignment of prisoners in a manner consistent with protocols approved 

by the IRB to control groups which may not benefit from the research, 

the study may proceed only after the Secretary has consulted with 

appropriate experts, including experts in penology medicine and ethics, 

and published notice, in the Federal Register, of his intent to approve 

such research.

    (b) Except as provided in paragraph (a) of this section, biomedical 

or behavioral research conducted or supported by DHHS shall not involve 

prisoners as subjects.