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IV.08
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Review of Research Involving Prisoners
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Objective
The Committee for the Protection of Human Subjects (CPHS) shall review
and approve all research involving prisoners with additional ethical and regulatory
considerations applicable to prisoners. If the participant population has an
increased potential to become prisoners and the principal investigator (PI)
will be interacting, intervening or collecting identifiable private information
during the possible incarceration, the PI may choose to have the research
reviewed initially by the CPHS and OHRP (if applicable) for prisoner
participation. This Policy/Procedure describes the review process by which CPHS
members review protocols submitted for initial review and approval involving
prisoners. (Minimal risk for a prisoner
means that 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 incarcerated persons.)
Policy/Procedure
I.
CPHS membership in addition to the standard
membership described in HRP PP II.01.
A. A majority of the CPHS
(exclusive of prisoner advocates) shall have no association with the prison(s)
involved, apart from their membership on the CPHS.
B. At least one member of the
CPHS must be a prisoner, or a prisoner representative with appropriate
background and experience to serve as an advocate, except that where a
particular research project is reviewed by more than one IRB, only one IRB need
satisfy this requirement.
C. When the convened CPHS
reviews research involving prisoners (including initial review, continuing
review, review of protocol modifications, and review of unanticipated problems
involving risks to participants or others), the prisoner or prisoner
representative must be present as a voting member.
D. The CPHS must review all
research in which prisoners are the target population, the participant is a
prisoner at the time of enrollment, or when a currently enrolled participant
becomes incarcerated and research interventions and interactions would occur
during the incarceration period or if identifiable private information will be
obtained during the incarceration period.
II. Research involving prisoners
must undergo initial review at a convened meeting, and it can not qualify as
exempt.
III. If a protocol involves the
use of prisoners as participants, both general policies and procedures and the
additional ones outlined in this procedure will be in effect. The CPHS may approve research involving prisoners only if the
following are met:
A. The research under review
represents one of the following categories of research permissible under 45 CFR
46.306 (a)(2)
1. 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 participants; or,
2. A 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 participants; or,
3. 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) ;or
4. Research on practices, both
innovative and accepted, which have the intent and reasonable probability of
improving the health or well-being of the participant.
B. 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.
C. The risks involved in the
research are commensurate with risks that would be accepted by non-prisoner
volunteers.
D. Procedures for the
selection of participants 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 CPHS justification in writing for following some other procedures, control
participants must be selected randomly from the group of available prisoners
who meet the characteristics needed for that particular research project.
E.
The information is presented in language which is understandable to the
participant population.
F.
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.
G. Where the CPHS 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.
H. The Subcommittee must
document in detail in the iRIS system how each of the
above seven criteria for additional protection are met. This shall include
protocol-specific information justifying each CPHS finding.
I.
The PI must provide documentation of approval from the detention or correctional
facility involved to the CPHS prior to approval
IV. Should a participant in a
study become incarcerated and the protocol was not originally reviewed and
approved for prisoners:
A. The PI must promptly
notify the CPHS of the event.
B. The CPHS will remind the
principal investigator that all research interactions and interventions with,
and obtaining identifiable private information about, the now-incarcerated
prisoner-participant must cease until all of the requirements of Subpart C have
been satisfied with respect to the relevant protocol.
1. Exception: The principal investigator must assert
that it is in the best interests of the participant to remain in the research
study while incarcerated. The chairperson may determine that the participant
may continue to participate in the research until the requirements of Subpart C
are satisfied for the relevant protocol
C. Upon receipt of
notification that a previously enrolled research participant has become a
prisoner, the CPHS should promptly re-review the protocol in accordance with
the requirements of 45 CFR §46, subpart C if the principal investigator wishes
to have the prisoner participant continue to participate in the research.
V. If research conducted or
supported by HHS is to involve
prisoners, two actions must occur:
A. The Secretary (through
OHRP) must determine that the proposed research falls within the categories of
research permissible.
B. The institution engaged in
the research must certify to the Secretary (through OHRP) that the CPHS
designated under its assurance of compliance has reviewed and approved the
research:
1. Based on the seven findings in 45CFR 46.305(a) This
may include a brief, protocol-specific explanation of the CPHS’ rationale for
each finding 45 CFR 46.305(a)(1)-(7)
2. Must indicate which of the four categories of
permissible research involving prisoners in 45 CFR 46.306(a)(2) is applicable
to the proposed research
3.
OHRP encourages the inclusion of
the following information with the letter
a) OHRP
Assurance #
b) IRB # for
Designated IRB
c) Site(s)
where research involving prisoners will be conducted
d)
If prisoner research site is engaged in research,
provide OHRP Assurance #
e) DHHS
Grant Award #
f)
DHHS Funding Agency Name
g) Funding
Agency/Program Officer Name and Phone #
h) Title of
DHHS Grant
i)
Title of Protocol – if the same as the title of the
grant, it should indicate such
j)
Version date of consent document to be used with
“prisoner”
k)
Date(s) of CPHS Meeting(s) in which protocol was
considered – provide a brief chronology
(1)
Date of initial CPHS review
(2)
Date of Subpart C reviews
(a)
Type of CPHS review (i.e. initial, amendment,
addendum, continuing review)
(b)
Special CPHS review for prisoner issues
l)
Name of the Investigator (s)
m) Reason
for CPHS review (choose the applicable reason(s))
(1)
Non-prison study (not previously reviewed and
certified under Subpart C) in which subject has become incarcerated (or
otherwise fits the definition of prisoner in 45 CFR 46.303(c)) and PI wishes to
continue subject’s participation in the study
(2) Non-prison
study with at-risk population (i.e., probationers, substance abusers)
(3)
Non-prison study, majority of study population are
non-prisoners but PI seeks to enroll some prisoners (as defined in 45 CFR
46.303(c))
(4)
Minimal risk DHHS conducted or supported
epidemiologic research, majority of study population are non-prisoners but PI
seeks to enroll some prisoners (prisoners are not the focus of the study) And
the sole purpose of the study is either:
(a)
to describe the prevalence or incidence of a disease
by identifying all cases, or
(b)
to study potential risk factor associations for a
disease
(5)
Initial Subpart C review of study designed to be
conducted in a prison or using prisoners (as defined in 45 CFR 46.303(c)) - PI
seeks to enroll already incarcerated subjects
4. It would be helpful (but not required) if the
prisoner certification letter contained the following information:
a)
Include a statement that indicates that the CPHS was
constituted as per the requirements in 45 CFR 46.30;
b)
Justification for the use of prisoners in the study -
if applicable, delineate the protocol to be conducted in the prison from the
overall project described in the grant application;
c)
Study objectives or study aims;
d)
Study procedures - brief summary;
e)
Customary treatment or services at the prison (or
alternative to incarceration) research site(s) for the condition being studied
;
f)
Description of how risks specific to a prison (or
alternative to incarceration) setting are minimized;
g)
Whether the prison site(s) are “engaged in research”
and whether they have obtained an assurance with OHRP
h)
Whether a Certificate of Confidentiality was
obtained by PI for the study. Describe recruitment procedures in the specific
prison (or alternative to incarceration) setting
i)
Describe recruitment procedures in the specific
prison (or alternative to incarceration) setting
j)
Describe how the consent form was altered for use
with a prison population or specific prisoner and whether subsequently
incarcerated subjects will be re-consented
5. OHRP recommends (but does not require) the inclusion
of category-specific information in the certification letter:
a)
If CPHS chose category (i)
or (ii) (III.A.1 & 2. above),
(after determining that the study satisfied the threshold condition for the
category), OHRP recommends that CPHS provide the rationale for determining that
the study is no more than the Subpart C definition of minimal risk. It would
also be helpful if the letter provided CPHS’ reasoning for the choice of this
category.
b)
If CPHS chose category (iii), (III.A.3 above) thus
triggering the requirement for Secretarial consultation with appropriate
experts, OHRP recommends that CPHS provide the rationale for the choice of
category and formally request that consultation in the letter.
c)
If CPHS chose category (iv) (III.A.4 above), OHRP
recommends that CPHS:
(1)
provide the rationale for determining that the study
is “research on practices....which have the intent and reasonable probability
of improving the health and well-being of the subject.”
(a)
OHRP recommends that the “practice” be described
- typically it will be an intervention
being studied.
(b)
If the study is an extension study or is a
free-standing follow-up study to another study that involves an intervention,
OHRP recommends that CPHS describe the relationship between this study and the
study with the intervention.
(2)
describe whether the study involves assigning
prisoners to control groups which may not benefit
(a)
If all subjects will be recruited and assigned to
study groups (including a control group) PRIOR to incarceration, then
“prisoners” will not assigned to a control group. Therefore, if CPHS is being
asked to review a study under Subpart C because a previously enrolled subject
now meets the Subpart C definition of “prisoner” and PI wishes to the continue
the participation of this prisoner-subject, there will be no trigger for a
Secretarial consult if the CPHS finds that the study fits under category iv.
(b) If the study DOES involve
assigning persons that meet the Subpart C definition of “prisoner” to a control
group “which may not benefit from the research”, the requirement for
Secretarial consultation with appropriate experts is triggered.
(c) Explanation of category iv
phrase “control groups which may not benefit from the research”:
(i) If
there is a study arm that provides treatment-as-usual, services-as-usual or the
standard medical care that would be available to the prisoner whether or not
he/she participated in the study, this type of study arm would be considered a
“control group” under Subpart C, category iv (45 CFR 46.306(a)(2)(iv)).
(ii) The
presence of a control group to which persons meeting the Subpart C definition
of “prisoner” may be assigned triggers a Secretarial consultation with experts,
which must occur after OHRP receives the prisoner certification and prior to
the involvement of any “prisoners” in the study.
(iii) If
there is a study arm that provides an intervention in addition to treatment-as
usual, or services-as-usual or standard medical care, OHRP would probably not
consider this type of study arm a Subpart C category iv “control group”.
VI.
The research may be approved for non-prisoner populations until all the
criteria in Subpart C are satisfied.
VII.
The CPHS shall inform the PI that no prisoner prisoner-subjects can be
enrolled or involved until the CPHS/institution receives a letter from OHRP
that acknowledges receipt of the prisoner certification and indicates OHRP’s determination regarding the 45 CFR 46.306 category.
VIII. When a prisoner is also a
minor (e.g. an adolescent detained in a juvenile detention facility is a
prisoner), HRP PP IV.10 will also apply.