When using prisoners as subjects the following additional concerns must be addressed:
- Selection of subjects within the prison is to be fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless providing justification otherwise, control subjects must be selected randomly from an appropriate population of prisoners.
- Any advantages accruing a prisoner subject, when compared to standard prison conditions, are not to be of such magnitude as to impair the prisoner's ability to weigh appropriately the risks of research participation in the limited choice environment of prison.
- The risks involved should be commensurate with risks that would be accepted by non-prisoner volunteers.
- Adequate evidence exists that parole boards will not take into account a prisoner's participation or non-participation in research and prisoners are informed in advance that participation or non-participation in the research will have no effect on parole decisions.
- Information must be provided to prisoners in language they can understand.
- An adolescent (e.g., age 14) detained in a juvenile detention facility is a prisoner.
- Where the CPHS/IRB finds there may be a need for follow-up examination or care of subjects after participation, adequate provision is made, taking into account the lengths of subjects' sentences, and subjects are informed.
- The guidelines apply whenever any human subject in a research project subject to 45 CFR 46 becomes a prisoner at any time during the study.
- If a subject becomes a prisoner after enrollment in research, the investigator should report this situation to Research Compliance Services immediately (541-346-2510.) If the investigator wishes to have the prisoner subject continue to participate in the research, all research interactions and interventions with and obtaining identifiable private information about the now-incarcerated prisoner-subject must cease until all requirements for research involving prisoners have been satisfied with respect to the relevant protocol.
- The exempt review categories do not apply to research involving subjects.
- The definition of minimal risk for research involving prisoners differs from the definition of minimal risk in subpart A of 45 CFR 46. See 45 CFR 46. 102(i). For research involving prisoners, the definition of minimal risk requires reference to physical or psychological harm, as opposed to harm or discomfort, to risks normally encountered in the daily lives, or routine medical, dental or psychological examination of healthy persons