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IRB Application: Vulnerable Populations
Section 5
FORM V. Research Involving Prisoners
There are special federal regulations which govern research involving prisoners enrolled as subjects. Subpart C of 45 Code of Federal Regulation (CFR) 46 applies whenever any human subject is a prisoner. A prisoner is defined as a person who is involuntarily confined/detained in a penal institution. If it is unclear if a person is deemed a “prisoner,” contact the Office of Research Integrity (ORI) at 859-257-9428 for help in making determination.
In order for the IRB to approve a study where prisoners are recruited, or to issue approval for a subject to continue participation when (s)he has become a prisoner during the course of the research, there are seven conditions that must be met and the research must fit into one of four categories. In order for the IRB to consider approval for prisoner participation in your study, Complete Form V and include it in your application submission. For your convenience, the IRB/ORI has provided a template of specific prisoner-related elements that should be included in the informed consent process and/or informed consent document: [WORD] [RTF]
If you are proposing research involving prisoners, please mark the appropriate selection in the space provided on the General Information Sheet [Section 1, Form A].
Note: If the study is HHS funded, or funding by HHS is sought, a certification report must be submitted to OHRP. The Office of Research Integrity will prepare and submit the certification report to OHRP. An approved certification letter from OHRP must be received before a research study can commence. The IRB will forward OHRP & IRB approval materials to the Principal Investigator.Specific DHHS epidemiology research may be eligible for a waiver. See Section 3 of Form V, or contact ORI at 859-257–9428 for further information.
Please note, per Kentucky Administrative Regulation (501 KAR 10:090) which sets forth requirements for delivery of medical services in jails, inmates are not permitted to participate in medical research (i.e. drug, device, biologic clinical trials). This state law does not apply to inmates of federal prisons. For assistance with applying state law to your research, contact ORI at 859-257-9428.