Challenges and solutions for conducting research in correctional settings: the U.S. experience.

Through the mid-1970s, most new drug clinical trials were conducted in America's jails and prisons. Due to the extensive human rights violations acknowledged at that time, laws were enacted that essentially brought corrections-based research to a halt. The Code of Federal Regulations, 45 CFR 46 subpart C, specifies the limitations upon research with correctional populations that are currently in place. These guidelines both informed the ethical conduct of research and arguably created a significant problem in today's correctional environment - prisoners are under-studied. We know far less about the health and health care needs of people under conditions of incarceration than those in the community. Linked with the extraordinary explosion over the last 20 years in the population of America's jails and prisons and with a disproportionate number of mentally ill inmates, inadequate knowledge currently exists to guide clinical decision-making. Over the last decade, a gradually growing body of work, ethically developed and clinically focused, has been evolving. This article presents the challenges of conducting correctional research in health and healthcare delivery. Legal, ethical, and pragmatic barriers are reviewed. Further, practical solutions that allow meaningful research to be conducted are presented. Such research can create a foundation for developing both public policy and clinical practice.