UK Office of Research Integrity

IRB Application: Vulnerable Populations

Section 5
FORM V.   Research Involving Prisoners

For studies involving *prisoners, or for studies recruiting subjects at risk of becoming involuntarily confined/ detained in a penal institution or other type of incarceration during the research (i.e., subjects with substance abuse history), complete "Form V" and include it with your IRB application submission. 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:
"An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)]. Note: Probation and parole are usually NOT considered as incarceration.

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.

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].

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]

Note: If you will receive or are seeking Department of Health and Human Services (HHS) funding for this study, a certification letter must be submitted to the Office for Human Research Protections (OHRP). The research cannot be initiated until OHRP issues approval. The Office of Research Integrity (ORI) will prepare and submit the certification report to OHRP. The IRB will forward OHRP & IRB approval materials to the Principal Investigator. Contact ORI at 859-257-9428 for more information.

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, under the Kentucky Administrative Regulation (501 KAR 3:090(14)) applicable to county jails (not federal prisons), 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, or Katherine Adams, Legal Counsel, at 859-257-2936.

According to the Commission of the KY Dept. of Corrections (DOC), In KY, prisoners may be housed in community corrections centers if they have the proper custody. If an offender with a monitoring device is serving home incarceration, he/she is an inmate and their home is an extension of their incarceration. However, if the offender is on parole with a monitoring device, they are not considered an inmate. Be aware that residential treatment programs may house BOTH individuals who are completing substance abuse programs that remain under state custody considered as prisoners, as well as parolees completing treatment.

 

 

 

 

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