Knowledge of Federal Regulations for Mental Health Research Involving Prisoners.

BACKGROUND: Given their vulnerability to coercion and exploitation, prisoners who participate in research are protected by Office for Human Research Protections (OHRP) regulations designed to ensure their safety and wellbeing. Knowledge of these regulations is essential for researchers who conduct and institutional review boards (IRBs) that oversee mental health research in correctional settings.

METHODS: We explored depth of knowledge of OHRP regulations by surveying a nationwide sample of: (1) mental health researchers who have conducted research in correctional settings; (2) mental health researchers who have conducted research in non-correctional settings; (3) IRB members who have overseen mental health research in correctional settings; (4) IRB members who have overseen mental health research in in non-correctional settings; and (5) IRB prisoner representatives. Participants responded to a 10-item knowledge questionnaire based on OHRP regulations.

RESULTS: 1,256 participants provided usable data (44.9% response rate). Results revealed limited knowledge of OHRP regulations, with a mean across groups of 44.1% correct answers. IRB Prisoner representatives, IRB members, and researchers with correctional experience demonstrated the highest levels of knowledge; however, even these participants were able to correctly answer only approximately 50% of the items.

CONCLUSIONS: Although awareness that prisoners are a protected population and that different regulatory procedures apply to research with them is likely to be universal among researchers and IRB members, our findings reveal limited mastery of the specific OHRP regulations that are essential knowledge for researchers who conduct and IRB members who oversee mental health research in correctional settings. Given well-documented health and healthcare disparities, prisoners could potentially benefit greatly from mental health research; increasing knowledge of the OHRP regulations among researchers and IRB members is a crucial step toward meeting this important public health goal.