To provide written guidelines regarding research on prisoners.
The Cottage Health System Institutional Review Board does not review research on prisoners.
This policy currently reflects:
• 45CFR46, Subpart C
• California Penal Code Section 3501-3509.5
• HHS Frequently Asked Questions – Prisoner Research
The term “prisoner” refers to any individual:
(1) involuntarily confined or detained in a penal institution;
(2) sentenced under a criminal or civil statute;
(3) detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution; and (4) detained pending arraignment, trial or sentencing.
Per California state regulations, biomedical research may not be conducted on prisoners. Accordingly, it is the IRB’s policy not to review biomedical research on prisoners. However, the IRB does recognize that participants enrolled in a research protocol may become prisoners. The same regulations that apply to prisoner enrollment in human subject research also apply to participants already enrolled in a study who suddenly become incarcerated. Moreover, federal regulations do not differentiate between detention, jail or prison. People incarcerated in any of these places are considered prisoners.
For ongoing research studies, investigators must notify the IRB immediately upon becoming aware of a current participant’s incarceration, and all interactions, interventions, and collection of protected health information (PHI) must cease. Steps should then be taken to withdraw the subject from the study.
EXCEPTION: The principal investigator may assert to the IRB that it is in the best interest of the participant to remain in the research while incarcerated. Upon receipt of the investigator's report that a previously enrolled research subject has become a prisoner, if the investigator wishes to have the prisoner subject continue to participate in the research, the IRB must promptly re-review the proposal in accordance with the requirements of subpart C, and the institution(s) engaged in the research involving the prisoner subject must send a certification to OHRP and wait for a letter of authorization in reply. Otherwise, the prisoner subject must stop participating in the research.
COTTAGE HEALTH SYSTEM POLICY
|ORIGINAL POLICY EFFECTIVE DATE: