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, etc.) and have insufficient power or resources to protect their own interests, which may make them susceptible to undue influence and/or coercion depending on their situation, their condition, or the research.
A prisoner is defined by the federal law for the protection of human subjects as any individual involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility) encompassing (1) individuals sentenced to such an institution under a criminal or civil statute; (2) individuals detained in other facilities (e.g., psychiatric unites, hospitals, or drug treatment centers) by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution in a penal institution; and (3) individuals detained pending arraignment, trial, or sentencing.
Probationers and individuals wearing devices that monitor their movements are generally not considered prisoners, however, they are considered justice-involved participants.
To review human subjects research involving prisoners, federal law requires that the 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.
Federal guidance expands on the regulations by recommending that all types of review involving justice-involved participants be reviewed by the convened IRB to meet the federal requirements and fully protect this vulnerable population. Brown follows this federal guidance.
Examples include: new submissions (primary or secondary data collection), revision requests, reportable events, etc.