Conducting health disparities research with criminal justice populations: Examining research, ethics, and participation

Introduction: A feature of both the 2006 Institute of Medicine report and existing US federal regulations designed to provide protection for prison populations is the absence of empirical data to guide researchers in the role and conduct of clinical research in community supervision settings (parole or probation). Methods: This study explored the challenges of informed consent and understanding of the research process among men under community supervision. Between February and October 2012, we conducted cognitive interviews of 259 men under community supervision using open-ended questions on the significant areas of research participation (informed consent process, confidentiality, compensation, what is meant by human subject and clinical trials). Content analysis of the open ended questions revealed limited knowledge concerning the understanding of research participation by men under community supervision. Results: Participants ranged in age from 35-67 (M = 47, SD = 6.63). Forty-six percent of participants identified as Latino, 49% identified as Black, and 5% selected other race/ethnicity. Sixty-two percent of the participants did not complete high school, 25% completed high school/GED, 10% obtained trade or some college, and 2% completed college. Forty-seven percent of the sample reported being unemployed. The study participants appeared to generally understand concepts such as compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process - informed consent, human subject, institutional review board, and clinical trials. Conclusion: These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies.