Including prisoners in substance abuse clinical trials.

This presentation, part of a panel at the Society for Clinical Trials annual meeting in 2012 focusing on ethical, regulatory, recruitment issues in vulnerable populations, covers the basic definitions and guidelines for including participants who are considered “prisoners” in substance abuse treatment research. In order to conduct research with prisoners, there are several additional, potentially complex steps that must be undertaken with the researchers’ institutional review board of record. Used as a practical example, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0044, “Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders,” is discussed, as approximately 35% of participants at baseline were either mandated or referred for treatment by the criminal justice system (a handful even wearing monitoring bracelets). In any trial, regardless of whether you have approval to conduct research with prisoners, the study must have procedures in place to determine if a participant is indeed a prisoner. Though this can be straightfoward if the participant is in a detention facility, there are a small number of cases where participants reside in the community but are considered a prisoner under the definition of the Office of Human Research Protections (OHRP). For CTN-0044, this mean the development of a screening procedure that asked a simple question about house arrest and followed-up with additional probes if necessary (for participants in this protocol, even those wearing ankle monitors were not officially considered “prisoners” because while their movements were restricted, they were allowed to come and go of their own accord to the treatment facility). The presentation provides an in-depth look at the issues surrounding research with prisoners, including the importance of including individuals who become incarcerated during a study to reduce bias.

Related protocols: CTN-0044