Guidance for Research involving Prisoners as Human Subjects

The federal regulations (45 CFR 46) specifically address research involving prisoners as human subjects in Subpart C and place numerous responsibilities both on the IRB and the principal investigator.  The Rutgers University IRB defines a prisoner as the following:

Individuals who are involuntarily confined or detained in a penal institution; other similar institutions (such as mental health institutions for criminals); sites for the detention of individuals pending arraignment, trial, or sentencing; or individuals on parole or probation.

It is vital to note that all research protocols that are conducted or funded by DHHS (e.g. NIH, NIMH, etc.) and involve prisoners as research subjects are required to be certified by the federal Office for Human Research Protections (OHRP). This is completed by the Rutgers IRB first conducting its own review, and then forwarding its review determination to (OHRP) for federal certification of Rutgers' IRB review. This process may take as long as 6 months to complete, and no work involving human subjects may commence until OHRP has certified the Rutgers IRB review. Appropriately preparing for this type of review can greatly decrease the review and federal certification time.

Please note that only projects that are conducted or funded by DHHS require OHRP certification of review. All other protocols that involve prisoners, and are not DHHS funded or not funded at all, will be reviewed by the Rutgers University IRB per the procedures outlined here and elsewhere on this web site.

To expedite the review process, it is highly recommended that the principal investigator educate themselves about compliance and ethical issues specific to research involving prisoners, and complete the Prisoner Checklist provided below (this checklist must be provided along with the protocol at the time of IRB review). The regulations require numerous additional determinations and considerations that both the IRB and the investigator must document, and so completeness of the protocol application greatly helps to expedite the process.  The following information below will assist principal investigators in addressing the ethical considerations for research involving prisoners:

Informed Consent Process:

It is vital to keep in mind that informed consent is not just a form, but an interactive process between the subject and the researcher.  This process must accurately convey to the subject what they will be involved in, that they can withdraw at any time without penalty, and who to contact in the future about questions pertaining to the research or their rights.  This information must be written in lay language, and devoid of any discipline specific jargon.

Additionally, all consent documents presented to prisoners or other incarcerated individuals (including minors) must include the following statement in the Consent Form:

Do not tell us any information about past or future crimes that are unknown to the authorities as we cannot guarantee confidentiality of that information.  Additionally, I [the researcher] must report to the authorities information you tell me about harming yourself or other people, or any plans you have to escape.

The consent form must also be written at a sixth grade reading level in order to ensure comprehension by the incarcerated subjects. 

National Institute of Justice Sponsored Research:

If the National Institute of Justice (NIJ) is the sponsor of the research, the PI will need to enter into a Privacy Statement with NIJ in order to ensure that appropriate procedures exist to ensure the protection of prisoners' privacy.  Additionally, the following regulations offer protections for research subjects that must be complied with for research sponsored by NIJ:

• 42 USC3789g (MSWord) This document outlines the terms of the Privacy Statement
• 28 CFR 22 (PDF) This document outlines the requirements for the storage and transfer of research data.
• 28 CFR 46 (PDF) This document contains generally the same requirements for the protection of human subjects as 45 CFR 46, which Rutgers complies with under the terms of its Federalwide Assurance (FWA00003913).

Guidance Information and the Prisoner Checklist for Investigators:

The following guidance has been posted on this web site, as cited, to assist investigators in writing a protocol application that addresses the numerous ethical and regulatory issues of research involving prisoners. 

• OHRP IRB Guidebook Chapter #6 Guidance from the IRB Guidebook, 1993.

Please note that this document is to serve only as a guide providing ethical considerations for research involving prisoners. Many of the regulatory requirements have been revised, expanded, and in certain cases waived, since the time this guidance was published by OHRP.

• General Areas of Non-Compliance Involving Prisoner Conducted Research (.pdf )
• Guidance Summary Table of Requirements for Prisoner Conducted Research (.pdf):
• Prisoner Checklist for Investigators (MSWord. Must be submitted along with protocol at the time of initial, amendment, and continuing review); 
• New Jersey Administrative Code (NJAC) 10A: Research involving prisoners in New Jersey State Prisons. (.pdf).

Please contact Michelle Gibel, CIM, IRB Administrator, for assistance in completing the application and for guidance on prisoner research related issues:

_________________________________________________

Michelle Gibel, CIM
IRB Administrator
Rutgers University Office of Research and Sponsored Programs
Email: gibel@orsp.rutgers.edu
Office:732-932-0150 x.2104
Fax: 732-932-0163
Mail: 3 Rutgers Plaza, ASB III
New Brunswick, NJ 08901

 

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