Division of Research

Prisoners Involved in Research

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Prisoners Involved in Research

When reviewing human subjects research involving prisoners, federal law requires that the Institutional Review Board (IRB) include a prisoner or prisoner representative with the appropriate background and experience to represent the participant population and be knowledgeable about the vulnerabilities of prisoners, and how they may be subject to coercion or undue influence.

This guidance covers new submissions for review (primary or secondary data collection), revision requests and reportable events.

Definitions

Prisoner

A prisoner is defined in U.S. Department of Health and Human Services regulations as any individual involuntarily confined or detained in a penal institution (e.g., prison, jail or juvenile offender facility) encompassing: 

  • individuals sentenced to such an institution under a criminal or civil statute; 
  • individuals detained in other facilities (e.g., psychiatric units, hospitals or drug treatment centers) by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution in a penal institution; and 
  • individuals detained pending arraignment, trial or sentencing.

Justice-Involved Participant

A justice-involved participant is any person targeted for human subjects research who may interact with the justice system (e.g., law enforcement, court system) and have insufficient power or resources to protect their own interests, which may make them susceptible to undue influence or coercion depending on their situation, their condition or the research.

Justice-involved participants do not meet the federal definition of “prisoners”; however, the IRB’s justice-involved representative will review submissions involving this population due to the vulnerabilities of their situation to ensure their safety and well-being.