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Human Subjects

Policies & Guidance

Research Involving Prisoners

Research involving prisoners is subject to additional regulation and requires additional safeguards due to past abuses with this subject population. Some regulations apply to all research that enrolls prisoners, and some are specific to the Indiana Department of Corrections or Federal Bureau of Prisons. Studies including prisoners as subjects are not eligible for exempt review.

A prisoner is defined by HHS regulations at 45 CFR part 46.303(c) as “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.

Examples of prisoners and non-prisoners

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Additional requirements

Due to the vulnerable nature of prisoners, investigators must be prepared to ensure additional safeguards are met, including providing assurances of the following:

  • Any possible advantages gained by the prisoner through participation in the research will not unduly influence the prisoner to participate, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison. The possibility for undue influence exists when the advantages are so great that a prisoner’s ability to weigh the risks of the research against the value of such advantages may be impaired.
  • The risks involved in the research are equivalent to those that would be accepted by non-prisoner participants. The investigator(s) should keep in mind that the prison environment can introduce risks to participating in research that are not present elsewhere.
  • Procedures for the selection of subjects within the prison are fair to all prisoners, and are not based on arbitrary decisions or intervention by prison authorities or prisoners.
  • Information about the study is presented to prisoner-subjects in language that is understandable to the subject population. Documents for subjects should be written at a 6th-8th grade reading level.
  • Parole boards will not take into account a prisoners’ participation in the research when making decisions regarding parole. Each prisoner must be clearly informed in advance that participation in the research will have no effect on his/her parole or release date.
  • If the IRB finds there may be a need for follow-up examination or care of subjects after the end of their participation in the research, adequate provision must be made for this examination or care, taking into account the varying lengths of individual prisoners' sentences. Subjects must also be informed of this fact.

In addition to the assurances above, investigators should be prepared to provide detailed information about the following:

  • PI’s experience with this population, including previous research experience and or/academic preparation for working and interacting with prisoners. The PI must also explain the qualifications of the remainder of the study team, including any relevant training provided by the PI and a plan for supervision of study personnel.
  • Letter/email of cooperation from any facility in which research will be conducted confirming that the facility has granted the investigators permission to use the site, or that permission will be granted upon IRB approval. If the researchers will access offenders’ jail files that are not public record, this must be noted in the letter or support.
  • Recruitment process, including recruitment materials. It is not sufficient, for example, to simply state that flyers will be posted in common areas. The investigator must detail the steps taken to prevent potential subjects from feeling coerced into participating.
  • Location(s) of interviews and interactions with subjects, including privacy features. The investigator must explain how the setting will preclude other prisoners, as well as facility officials, from overhearing or recording the discussion. If this is not possible, subject must be clearly advised of this fact at the beginning of each interview or interaction.
  • Plan for communication with research subjects, bearing in mind that prisoners’ ability to contact investigators may be limited. Communication plan may require the involvement of facility officials.

Federally-funded research with prisoners

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Facility-specific requirements

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