Version
1.0
Date Updated
Saturday, March 10, 2012
Descripton

Approved by:  Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#:  191
AAHRPP Elements:  I.1.A., I.1.D., I.1.F., II.4. A.,II. 4.B, III.1.A., III.1.C., III.1.F, III.2.A.


POLICY


  1. Potential research subjects who are prisoners are at increased risk for coercion and undue influence as a result of their incarceration. To ensure their participation in research is uncoerced and voluntary, additional protections are afforded this population. Only UIC IRBs that meet composition requirements in Procedure Section III of this document are permitted to review protocols involving prisoners as subjects. The applicable UIC IRBs approve research involving prisoners only if the research complies with the safeguards described in this policy. This policy applies whether the research involves individuals who are prisoners at the time of enrollment in the research, who become prisoners after they are enrolled in the research, or their status as prisoners is incidental to the research.
  2. Definitions. The following definitions are taken from 45 CFR 46.303.
    1. PRISONER: 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 provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing. Common examples fitting the regulatory definition of prisoner include:
      1. Individuals in any kind of penal institution, such as a prison, jail, or juvenile offender facility whose ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial.
      2. 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.
      3. 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.
      4. 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.
      5. 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.
    2. MINIMAL RISK: 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. Note: This definition of minimal risk differs from that in 45 CFR 46 Subpart A by replacing “harm or discomfort” with “physical or psychological harm” and using “healthy person” as the reference point for the medical, dental or psychological examinations.
  3. For research involving prisoners as participants, the UIC IRB follows federal regulations at 45 CFR 46 Subpart C in addition to those imposed under other UIC HSPP policies and procedures, ethical considerations and other applicable federal, state and local laws for review and approval regardless of funding source.
  4. The exemptions from IRB review at 45 CFR46.101(b) do not apply to research involving prisoners.
  5. Expedited procedures for review of prisoner research are only allowed:
    1. when research does not involve interaction with prisoners (e.g., record review, existing data), or
    2. to secure approval for minor or administrative modifications.   
  6. VA Research: Research involving prisoners cannot be conducted by VA investigators while on official VA duty, using VA resources, completely or partially in a VA facility or at a VA-approved off-site facility unless a waiver has been granted by the CRADO.  Procedures equivalent to VHA Handbook 1200.05, paragraph 47c are described in the Procedures section IV. Measures to be Taken When a Current Research Subject Becomes a Prisoner of this policy.
  7. Department of Defense (DoD).  The DoD applies subpart C with some modifications.  Please refer to UIC HSPP Policy Research Involving Department of Defense Components for more detail.
  8. Medical, cosmetic, or pharmaceutical experiments involving prisoners are prohibited for research to be conducted within the Illinois Department of Corrections. (Title 20 Corrections, Criminal Justice, and Law Enforcement Chapter 1: Department of Corrections: part 106, Research and Evaluation). Therefore, even though these types of research with prisoners may be approvable under federal regulations, they are not permitted under Illinois state law.
  9. UIC policy generally requires that the review of research involving prisoners be performed by the convened IRB. The exception is protocols originally approved by the convened IRB and remaining active only for data analysis may be eligible for expedited review (expedited category 8.C). (Refer to UIC HSPP policy and procedure Expedited Review for Initial and Convened Review and Amendments).