Prisoners, when involved in a research study, are considered a vulnerable population subject to additional protections. UAMS IRB Policy 17.9 covers the basics about prisoner research, and OHRP has additional resources and information available. Here’s a recap of some of the considerations related to prisoners in research.
Anyone “involuntarily confined or detained in a penal institution” is a prisoner, OHRP says. Whether they’ve been convicted of a crime doesn’t play into the “prisoner” determination; people can either be confined while awaiting trial or already convicted and serving a sentence. People who are out on parole and/or wearing a monitoring device but not confined are generally not considered prisoners. The key test is whether the person can come and go at will. If they can, they’re probably not a prisoner. If not, they’re a prisoner.
The IRB has special composition requirements when reviewing prisoner research. The majority of the IRB Committee shall have no association with the prison(s) involved and at least one reviewer shall be a prisoner representative with appropriate background and experience to serve in that capacity. These requirements must be met for all types of review (initial review, major modifications, and continuing review unless no subjects have enrolled, in which case the study can be reviewed as expected category 8).
Research involving prisoners does not qualify for exempt status review, and can only be reviewed using expedited procedures under one of the following conditions:
- For research involving interaction with prisoners, the study involves no greater than minimal risk to the population being studied. In these cases, the prisoner rep must be involved in the initial review, and also in the review of all modifications and continuing reviews.
- For research not involving interaction with prisoners, but uses identifiable private information about them, the study involves no greater than minimal risk. The prisoner rep may participate in the review of these studies but is not required to do so. However, if the prisoner rep reviews the initial submission, he or she must also review subsequent modifications or continuing reviews.
When reviewing prisoner research, the IRB must make seven specific findings, which our IRB uses a checklist to document. The findings are summarized here; see the policy for the complete descriptions:
- The research falls into one of the following categories
- A study of possible causes, effects, and processes of incarceration and of criminal behavior (must be minimal risk)
- A study of prisons as institutional structures or of prisoners as incarcerated persons (must be minimal risk)
- Research on conditions particularly effecting prisoners as a class (requires HHS consultation and approval)
- Research on practices which have the intent and reasonable probability of improving the health or well-being of the subject (requires HHS consultation and approval in some cases)
- Certain epidemiological research
- Any possible advantages accruing to the prisoner are not of such a magnitude as to possibly impair the prisoner’s ability to weigh the risks of the research against the value of such advantages.
- The risks involved are commensurate with those that would be accepted by nonprisoner volunteers.
- Procedures for selecting prisoner subjects are fair and immune from arbitrary intervention by prison authorities or prisoners.
- The study information is presented in language understandable to the subject population.
- Adequate assurance exists that the parole board will not take into account a person’s research participation in making decisions, and each prisoner is informed that participation will have no effect on parole decisions.
- If the IRB finds a need for follow-up exam or care of participants, adequate provision has been made for such follow-up.
Note that if a previously enrolled subject becomes a prisoner during participation, the study is now subject to the prisoner regulations if the subject is to remain in the study. The investigator should notify the IRB immediately of this change in the subject’s status and indicate whether the subject will be dropped from the study or continue participation. If the latter, the study must be re-reviewed under the prisoner requirements. No more interaction can occur and no more identifiable private information about the subject may be obtained until the study is re-reviewed.