PRIM&R is pleased to bring you a post from Dawnett Watkins, a member of the PRIM&R Blog Squad at the 2011 Advancing Ethical Research Conference. The PRIM&R Blog Squad is composed of PRIM&R members who are devoted to blogging prior to, live from, and after our conferences.

How do the current guidelines define who is a prisoner?  45 CFR 46 states: 

‘Prisoner’ means any individual involuntarily confined or detained in a penal institution.  The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

This definition includes situations where a human subject becomes a prisoner after the research has commenced.

But, what about a mental health jail diversion program that is an alternative to prison, where the participants are not detained per se? Instead, they are court-ordered to participate in a non-residential community program, where they wear ankle monitors for a portion of the time. These participants are not under Department of Corrections (DOC) supervision, but instead are under court supervision.  The CITI training definition of who constitutes a prisoner is important to review when considering this particular situation. CITI states:

Individuals who are detained in a residential facility for court-ordered substance abuse treatment as a form of sentencing or alternative to incarceration are prisoners; however, individuals who are receiving non-residential court-ordered substance abuse treatment and are residing in the community are not prisoners.

The guidance surrounding the use of monitoring devices is also unclear. CITI training says, “individuals wearing monitoring devices are generally not considered to be prisoners; however, situations of this kind frequently require an analysis of the particular circumstances of the planned subject population.”

When our campus asked our state DOC representative about the situation described above, the answer was, “it depends.”  The book, Institutional Review Board: Management and Function, by Elizabeth A. Bankert and Robert J. Amdur, expanded further: “One of the difficulties in the use of subpart C lies within the definition of ‘prisoner’. Many of the current alternatives to incarceration were not even in existence at the time of the writing of subpart C, such as house arrest with electronic monitoring. “ 

We are told over and over again at PRIM&R conferences that the guidelines are a minimum.  Our institutional review board (IRB) also recognizes that other groups may not meet the definition of a prisoner, for example, parolees or probationers, persons court-ordered to attend non-residential treatment programs in the community, and those adjudicated to reside in halfway houses.  As we found out via our prisoner representative, the DOC may or may not consider these people to be under its jurisdiction, and if they aren’t under the DOC, are they even prisoners? 

All of these people have impingements on their freedom, and as a result, the potential for coercion exists.  For these vulnerable subjects who may not be protected under subpart C, our IRB has decided that they should be afforded additional protections under subpart A, which charges IRBs to be particularly cognizant of the special problems of research involving vulnerable populations.

There aren’t always clear-cut answers in human research protections, which makes the jobs of those in the field both interesting and challenging.  The bottom line is, however, ensuring the protection of human subjects, and when in doubt, I feel it is always best to go beyond the minimum.