[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR46.306]

[Page 125]
 
                        TITLE 45--PUBLIC WELFARE
 
                           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 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.