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Additional DHHS Protections Pertaining to Biomedical
and Behavioral Research Involving Prisoners as Subjects |
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Source: 43 FR 53655, Nov. 16, 1978. |
(a) The regulations in this subpart are applicable to all biomedical and
behavioral research conducted or supported by the Department of Health and
Human Services involving prisoners as subjects.
(b) Nothing in this subpart shall be construed as indicating that compliance
with the procedures set forth herein will authorize research involving
prisoners as subjects, to the extent such research is limited or barred by
applicable State or local law.
(c) The requirements of this subpart are in addition to those imposed under
the other subparts of this part.
Inasmuch as prisoners may be under constraints because of their
incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as
subjects in research, it is the purpose of this subpart to provide additional
safeguards for the protection of prisoners involved in activities to which this
subpart is applicable.
As used in this subpart:
(a) "Secretary" means the Secretary of Health and Human Services
and any other officer or employee of the Department of Health and Human
Services to whom authority has been delegated.
(b) "DHHS" means the Department of Health and Human Services.
(c) "Prisoner" means any individual involuntarily confined or
detained in a penal institution. The term is intended to encompass individuals
sentenced to such an institution under a criminal or civil statute, individuals
detained in other facilities by virtue of statutes or commitment procedures
which providealternatives to criminal prosecution or
incarceration in a penal institution, and individuals detained pending
arraignment, trial, or sentencing.
(d) "Minimal risk" is the probability and magnitude of physical or
psychological harm that is normally encountered in the daily lives, or in the
routine medical, dental, or psychological examination of healthy persons.
§46.304 Composition of Institutional Review Boards
where prisoners are involved.
In addition to satisfying the requirements in §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.
§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 §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.
§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 §46.305
of this subpart; and
(2) in the judgment of the Secretary the proposed
research involves solely the following:
(A) 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;
(B) study of prisons as institutional structures or
of prisoners asincarcerated persons, provided that
the study presents no more than minimal risk and no more than inconvenience to
the subjects;
(C) 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
(D) 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 the 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.