PRISONERS
SECTION 1.
For studies involving prisoners or people at risk of becoming involuntarily detained during the research (e.g., subjects with substance abuse history), respond to the following items.
For research involving prisoners, the definition of minimal risk refers to the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Select the category below that best represents your research and explain why your research meets the criteria.
Prisoner Categories
- Category 1: My research involves the study of possible causes, effects, processes of incarceration, and of criminal behavior. (Processes of incarceration can be interpreted broadly to include substance abuse research, halfway houses, counseling techniques, criminal behavior, etc.)
- Category 2: My research involves the study of prisons as institutional structures, or of prisoners as incarcerated persons. (This category is usually used fairly narrowly – i.e., looking at prisoner diet, conditions of prison, etc.)
- Category 3: My research involves the study of conditions particularly affecting prisoners as a class. (This category is rarely used – e.g., vaccine trials, research on hepatitis, social and psychological problems such as alcoholism, drug addiction, sexual assaults. Minimal risk studies should not go under this category.)
- Category 4: My research involves the study of practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. (Rare for research involving placebo or control groups to fall in this category because of the difficulty in justifying improvement of the health or well-being of the subject being given a placebo or in a control group.) Note: Contact the Office of Research Integrity at (859) 257-9428 for more information.
- Epidemiologic Research Involving Prisoners [See also SECTION 3 below]
Due to programming limitations, you will just need to enter 'N/A' in the text box below.
Enter information.
SECTION 2.
When an IRB is reviewing a protocol in which a prisoner will be a subject, the IRB must find and document justification that six additional conditions are met. Describe in the space provided how each condition applies to your research.
NOTE: If your study only involves epidemiologic research, you may insert "N/A" in each of the text boxes in this section (Section 2). Your response to Section 3 will determine appropriateness for "N/A" answers here.
Condition 1. Advantages acquired through participation in the research, when compared to the prisoners’ current situation, are not so great that they impair their ability to weigh risks.
Describe the possible advantages that can be expected for prisoner participants:
Enter information.
Condition 2. Risks are the same as those that would be accepted by non-prisoners.
Describe the possible risks that can be expected for prisoner participants and justify that they are the same as for non-prisoners:
Enter information.
Condition 3. Procedures for selection are fair to all prisoners and are immune from intervention by prison authorities in prisons; control subjects must be randomly selected.
- a) Describe how prisoners will be selected for participation: Enter information.
- b) Describe what measures will be taken to prevent intervention by prison authorities in the selection process: Enter information.
Condition 4. Parole boards cannot take into consideration a prisoner’s participation in research. Informed consent must state that participation will not impact parole.
Describe what measures are in place to ensure parole boards are not influenced by prisoners’ participation in research, and how prisoners will be told their participation (or refusal or withdrawal from) will not impact parole:
Enter information.
Condition 5. For studies that require follow-up, provisions are made, including consideration for the length of individual sentences; informed consent must reflect provisions for follow-up.
Describe what provisions have been made for follow-up and how this information will be relayed to the prisoner participants:
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Condition 6. Information about the study is presented in a language understandable to prisoners.
Describe what efforts have been made to present information about the study in a language understandable to the prisoner population:
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SECTION 3. Epidemiologic Research Involving Prisoners
Only complete if applicable:
Effective June 20, 2003, DHHS adopted a policy that allows waiver of the requirement for documenting applicability of a category (as found in Section 1 of this form) for certain epidemiologic research involving prisoners. This waiver applies to epidemiologic research on prisoners that presents no more than minimal risk and no more than inconvenience to the prisoner-subjects.
- Check this box if your research meets all three criteria listed below, then provide justification in the space provided.
- I request a waiver for meeting the category conditions under Section 1 of this form.
- My research involves epidemiologic research intended to describe the prevalence/incidence of a disease by identifying all cases, or to study potential risk factor associations for a disease; and
- Prisoners are not the sole focus of my research.
Justify how the research presents no more than minimal risk and no more than inconvenience to the subjects: Enter information.
SECTION 4. Prisoners are not the targeted population
Only complete if applicable:
Although prisoners may not be the target population for your research, a subject could become a prisoner during the course of the study (particularly if studying a subject population at high-risk of incarceration).
Note: If you did not receive IRB approval for the involvement of prisoners, and a subject becomes a prisoner during the study, all research activities involving the now-incarcerated participant must cease until IRB approval has been issued for their continuation in the research. If you need IRB approval for a prisoner subject to continue participation in your research, select and complete the applicable category from Section 1, complete Section 2, and this section, then submit for IRB review.
In special circumstances where it is in the best interest of the subject to remain in the research study while incarcerated, the IRB Chairperson may determine that the subject may continue to participate in the research prior to satisfying the requirements of Subpart C. However, subsequent IRB review and approval of this completed form is required.
- Prisoners are not a target population for my research, but a subject became a prisoner during the study, and I am seeking IRB approval so the subject can continue participation in the research.
Explain the importance of continuing to intervene, interact, or collect identifiable private information during the participant’s incarceration:
Enter information.
SECTION 5. Kentucky (KY) Department of Corrections (DoC) Approval
Review the following conditions and determine whether any apply to your study:
- active recruitment of participants from a correctional facility (prison, jail, or community corrections institution);
- active recruitment of individuals under community supervision from a state probation and parole office.
If any of the above conditions apply to your research, refer to the Kentucky Department of Corrections Policy and Procedures, Management Information and Research (Chapter 5) for information about submitting a proposal for DoC approval of research including the DoC approved Research Consent and Research Agreement (5.1.G.1). If the Department of Corrections is directly involved in your research as a sponsor or otherwise, contact the Office of Legal Counsel at 859-257-2936 and ask to be connected with a research attorney for additional information.
