Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 34
Effective Date: 10/8/2021

Policy

The CSS IRB does not currently review research involving prisoners. If this were to change, procedures consistent with the requirements of Subpart C of 45 CFR 46 will be developed.

If a subject were to become incarcerated while participating in a study that has not been approved for inclusion of prisoners, the IRB must be notified immediately so that the IRB can determine whether the subject may continue in the research, whether additional safeguards are needed, and to make the determinations required by the regulations.

Research involving prisoners that is under the oversight of an external IRB must comply with the requirements of that IRB and applicable policies and law.

Research with Prisoners

Research that proposes to involve prisoners as subjects requires special protections under the federal regulations because these individuals may not be free to make voluntary decisions about participation and may be subject to coercion or undue influence.  The Office for Human Research Protections (OHRP) provides the following guidance:

“Prisoner" is defined by HHS regulations at 45 CFR part 46.303(c) as "any individual involuntarily confined or detained in a penal institution.  The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing."

Because the ethical requirements for a study that targets or includes prisoners as subjects can involve additional protections or safeguards, the IRB review process is often more stringent and lengthier.  In addition, if IRB approval is granted, this approval may need to be certified at the federal level by the Office for Human Research Protections (OHRP).

One particularly important note:  The regulations and standards for research involving prisoners are not limited only to those studies that target prisoners but can apply whenever any human subject in a research protocol becomes a prisoner at any time during the study.

What should be done when a subject becomes a prisoner after enrollment in a study which was not reviewed and approved by the IRB in accordance with the requirements of subpart C (research involving prisoners)?

If appropriate, in a section for vulnerable participants include justification for inclusion of vulnerable participants and recruitment strategy. Include safeguards for protecting vulnerable populations. Please refer to OHRP guidelines when choosing the study population. Note that these regulations apply if any participants are members of the designated population, even if it is not the target population (e.g., if a participant becomes a prisoner during the study).

When a previously enrolled research subject becomes a prisoner and the relevant research protocol was NOT reviewed and approved by the institutional review board (IRB) in accordance with the requirements of HHS regulations at 45 CFR part 46, subpart C, the principal investigator should promptly notify the IRB of this event.  All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-subject must cease until the requirements of subpart C have been satisfied with respect to the relevant protocol.

If a participant becomes incarcerated (or otherwise meets the definition of prisoner noted above) during the course of an IRB approved research study, STOP all research-related interactions and data collection with that subject and contact the CSS IRB immediately for guidance.  OHRP allows for only one exception to this rule and that exception must be determined by the IRB Chair.

NOTE: OHRP has allowed one important exception.  In special circumstances in which the principal investigator asserts that it is in the best interests 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 until the requirements of subpart C are satisfied. (OHRP – Prisoner Involvement in Research (2003))

In addition, an adolescent detained in a juvenile detention facility IS considered a prisoner. Therefore, in most cases, the requirements of both Subpart C and Subpart D must be met.

If a study is being developed that may relate to prisoners or prison settings or involves participants that may become prisoners during the course of the research, contact the CSS IRB for guidance.

Resources

Metropolitan State University of Denver -

https://www.msudenver.edu/irb/guidance/vulnerablepopulations/researchwithprisoners/

Allina Health HRPP/IRB SOP Version 04/20/2020 -

https://www.allinahealth.org/-/media/allina-health/files/for-medical-professionals/research/allina-researc h-administration-home/hrpp-irb-sop-manual.pdf

Office for Human Research Protection  (OHRP) – Prisoner Involvement in Research (2003)

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/prisoner-research-ohrp-guidance-2003/ind ex.html

Children’s Hospital of Philadelphia(CHOP) When Study Subjects become Prisoners after Enrolling in a Clinical Research Study https://irb.research.chop.edu/prisoners

NIH Protocol Template for Behavioral and Social Sciences Research – Inclusion/Exclusion Criteria https://www.nccih.nih.gov/grants/toolbox

This is a new policy per the 2018 Common Rule Requirements.