Regulatory Science Symposium: Special Populations Session 6: Working in Criminal Justice Settings (2017)

1. Background of treating prisoners as special population:
   1. 1976 report published on “Research on Prisoners” was based on two ethical considerations:  respect for persons and justice.
   2. Was followed by the Belmont report which is practiced today.
2. Recommendations of the National Academy:
   1. 5.1 – Apply a risk benefit framework to research review before enrolment of vulnerable population. US Department of Health and Human Services to make changes to regulation on working with prisoners
   2. 5.2 – Use a collaborative approach: Under ethical ways to find ways to obtain input and conduct any research protocol involving prisoners.
   3. 5.3 – Ensure adequate standards of care- responsible for ensuring research in prisoners occurs in appropriate healthy environment and well-being.
   4. 5.4 – Support critical areas of correctional research – facilitate funding to conduct research on needed support for them to re-enter into society, reduce recidivism and inform policy makers about the humane and effective strategies for the operation of correctional systems.
3. Modifications due to 2007 National Academy Report:
   1. The research presents no more than minimal risk and inconvenience to the prisoner- subjects.
   2. Prisoners are not a particular focus of the research. The specific type of epidemiological research supported by DHHS and subjects to proposed waiver involves no more than minimal risk.
   3. The range of studies to which the proposed waiver would apply includes epidemiological research related to chronic diseases, injuries and environmental health that can use epidemiologic methods.
   4. Practical applications of specifics with prisoners differ from other categories of human subjects at federal and state level research. Specifics to be aware of are far more restrictions, reporting (federal NIH, DHHS, NIJ, IRB) and multiple system reporting.
4. Alternatives to consider in research:
   1. Pre and post release people(pre-trial, probation, parole)
   2. Formerly incarcerated
   3. Other alternatives include Epidemiological waiver and research on the prison system.

Accompanying text created by Vaibhavi Chokshi | Regulatory Science Graduate Student Worker | vmchoksh@usc.edu