Prisoner Research

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					Introduction

The regulations governing research with prisoners might apply to
you even though you think they don’t:

   Is your research a therapeutic drug or device trial for cancer,
       heart disease, HIV, tuberculosis or other condition where a
       subject might become incarcerated during their course of
       investigational treatment?
   Does your interventional research involve the study of subjects
       whose excessive drinking or use of illicit drugs might put
       them at higher risk of becoming incarcerated during the
       course of their participation in your research?
   Does your research take place in the emergency department, the
       ICU, an inpatient drug treatment facility or elsewhere where
       incarcerated patients might be treated?
   Do you plan to conduct research on individuals who have been
       previously incarcerated or who, by virtue of their lifestyles,
       may be at greater risk for becoming incarcerated?
If so, then the federal regulations for prisoner research could apply
to you.



Who are prisoners?

The federal regulations state that prisoner means any individual
involuntarily confined or detained in a penal institution such as a
prison, jail, or juvenile offender facility. 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 provide
alternatives to criminal prosecution or incarceration in a penal
institution; and individuals detained pending arraignment, trial, or
sentencing.

Common examples of the application of the regulatory definition
of prisoner are as follows:

 Individuals who are detained in a residential facility for court-
     ordered substance abuse treatment as a form of sentencing or
     alternative to incarceration are prisoners; however,
     individuals who are receiving non-residential court-ordered
     substance abuse treatment and are residing in the community
     are not prisoners.
 Individuals with psychiatric illnesses who have been committed
     involuntarily to an institution as an alternative to a criminal
     prosecution or incarceration are prisoners; however,
     individuals who have been voluntarily admitted to an
     institution for treatment of a psychiatric illness, or who have
     been civilly committed to nonpenal institutions for treatment
     because their illness makes them a danger to themselves or
     others, are not prisoners.
 Parolees who are detained in a treatment center as a condition of
     parole are prisoners; however, persons living in the
     community and sentenced to community-supervised
     monitoring, including parolees, are not prisoners.
 Probationers and individuals wearing monitoring devices are
     generally not considered to be prisoners; however, situations
     of this kind frequently require an analysis of the particular
     circumstances of the planned subject population. Institutions
     may consult with OHRP when questions arise about research
     involving these populations.


Historical background
Research ethics and oversight, as we know them today, grew out of
such historical incidents as the Nuremberg Trials and the Tuskegee
Syphilis Study. The set of regulations designed to provide
additional protections to prisoners evolved in a similar manner.
Leading up to WWII, the practice of using prisoners in research
went largely unchecked in the U.S. and internationally. During
WWII, the country was so focused on the war that research being
conducted in correctional facilities went mostly unnoticed. Those
who did notice, in general, favored the use of prisoners as research
subjects largely because either they saw this as a means of
additional punishment, or because they saw this as an opportunity
for redemption for the prisoners. They believed that research
participation offered prisoners a chance to contribute to the greater
good at a time when all citizens were being asked to make personal
sacrifices. During this time, little, if any, attention was paid to the
methods used to recruit prisoners, the amount of coercion that was
being applied to prisoners, or whether the eligibility criteria were
being met.

In the 1970s, after years of what many would consider abuse and
inappropriate use of prisoners as research subjects, things changed.
Several widely publicized studies not involving incarcerated
subjects were found to be abusing or misusing subjects, and this
shocked the public. As a result, the public opinion of medical and
behavioral research took a complete turn, and enrollment of
incarcerated subjects was stifled for decades.



Why enroll incarcerated subjects?
Currently, enrollment of incarcerated subjects is not the norm for
BU/BMC. However, given the Institution’s mission to serve the
underserved, it makes sense that the incarcerated should be given
the opportunity to be included in research studies whenever
appropriate.
One negative result of the overly zealous protections of this
population in the past has been that the integrity of many protocols
was jeopardized because many subjects who became incarcerated
were lost to follow-up. In keeping with the methodological
principle of validity, it could be considered inappropriate to
automatically remove all subjects who become incarcerated from a
study, as this could compromise the validity of the research. Also,
in consideration of the ethical principle of distributive justice, such
justice is compromised when problems that are common among
prisoners are not adequately studied in this population.



The Federal Regulations: Subpart C
The federal regulations referred to as Subpart C Additional
Protections Pertaining to Biomedical and Behavioral Research
Involving Prisoners as Subjects


provide for the inclusion of incarcerated individuals in research
under certain circumstances. It is very important to note that these
regulations must be applied to any research (including chart
review) where one or more incarcerated individuals are involved,
regardless of whether or not these individuals signed an informed
consent form prior to becoming incarcerated.

As explained in OHRP’s Prisoner FAQs, #19, if a human subject
involved in ongoing research becomes a prisoner during the course
of the study, and the IRB protocol was not approved for enrollment
of prisoners, then the investigator must promptly notify the IRB;
and all research interactions and interventions with, and
obtaining identifiable private information about, the now-
incarcerated prisoner-subject must be suspended immediately
(except as noted at the end of this paragraph). If the investigator
wishes to have the prisoner-subject continue in the research, then
the IRB must promptly re-review the protocol and make Subpart C
findings. In some instances, the IRB will have to send a
certification to OHRP and wait for a letter of authorization in
reply. Otherwise, the prisoner-subject must be removed from the
research. The one exception is that, if it is in the best interests of
the prisoner-subject to remain in the research study while
incarcerated, then the prisoner-subject may continue to participate
in the research until the requirements of Subpart C are satisfied.
The investigator must promptly notify the IRB of these special
circumstances so that the IRB can re-review the study.

Under Subpart C, IRBs are required to have at least one voting
board member who is a prisoner representative



in order for that person to review prisoner research. This prisoner
representative must be a prisoner, or must be a person who has the
close working knowledge, understanding and appreciation of
prison conditions from the prisoner’s perspective to serve as a
prisoner representative. BUMC IRB has had a prisoner
representative since 2003. The regulations require that the prisoner
representative be at the full board meetings when studies involving
incarcerated subjects are reviewed.

Under Subpart C, when an IRB reviews protocols involving
prisoners, in addition to its regular findings, the IRB must make
seven additional findings. These findings are briefly summarized
below, but you may click here for more detail about each of the
findings. The IRB must determine that;

   (1) the research fits into one of the permissible categories;

   (2) any possible advantages accruing to the prisoner through his
or her participation in the research are not of such a magnitude that
his or her ability to weigh the risks of the research against the
value of such advantages 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; and in most cases, 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 IRB 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.



Investigator Responsibilities
Whether the protocol is initially written to include incarcerated
subjects, or is amended to include incarcerated subjects who are
already enrolled, the investigator must:
 As a pre-emptive measure, when appropriate, include a check
     box in the consent form to ask subjects whether they agree to
     be contacted should they become incarcerated.
 In the INSPIR protocol, make sure Sections F1, F2, H, I, J, and K
     reflect the fact that incarcerated subjects may be enrolled in
     the research.
 Create a separate consent form for prisoners in Section Q. This
     consent form must address the procedures that will occur
     when they are incarcerated.

 Draft a letter that would be used to contact the correctional
    facilities to request permission to contact the individual for
    research purposes. Correctional institutions will have specific
    rules to be followed in order to contact prisoners; in
    Massachusetts, this letter will probably be directed to the
    HIV Coordinator at the particular facility. Attach a copy of
    this letter in Section S.
 Complete a copy of the Prisoner Research information sheet and
    attach it in Section S of INSPIR.


Few additional points regarding prisoner
research
Listed below is some additional important information regarding
prisoner research. For details, please go to the OHRP FAQs.

  Research on prisoners cannot be exempt.
  Waiver of informed consent for emergency research is not
     applicable to research involving prisoners.
  OHRP recommends that all research involving prisoners be
     reviewed by the convened IRB (full board).

 Informed consent and documentation of informed consent can be
     waived for prisoner research as long as the waiver is
     reviewed and approved by the IRB. However, under Subpart
     C, even if consent is waived, incarcerated subjects must still
     be clearly informed in advance that participation in the
     research will have no effect on their parole, if such
     notification is relevant.


Summary
The inclusion of prisoners in some research is appropriate and
consistent with the mission of the Institution. There are additional
regulatory requirements that must be met for a study where any
prisoners will be enrolled. Investigators should utilize the
extensive information available on the OHRP website to determine
whether enrollment of prisoners in their research is appropriate.

				
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