Prisoner Research

Relevant Policy/Procedure

• IRB Policy 2.15 Research lnvolving Special Populations
• See all  IRB policies/procedures

This checklist is used when the Principal Investigator thinks that a participant may become a "prisoner" or a "prisoner" will become involved in a research protocol at Fred Hutch.

Based on the definition taken from 45 CFR 46:302-306, subpart 46.303, "a prisoner is 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."

If a previously enrolled research participant becomes a prisoner and the research protocol was not reviewed and approved by the IRB in accordance with the requirements of 45 CFR part 46, subpart C, the PI must immediately notify the IRB of this event. All research interactions and interventions with, and obtaining identifiable private information about, the now-incarcerated prisoner-participant, must stop until the requirements of subpart C has been approved. If the Principal Investigator asserts that it is in the best interests of the research participant to remain in the research study while incarcerated, he/she must provide rationale to continue with the treatment/intervention to the IRB. See below for specific instructions and the required attachments to be submitted.

If the Principal Investigator does not seek or obtain IRB approval to include prisoners in the study, the now incarcerated participant can no longer be involved in the study until such time as the participant is released from their status as a prisoner. When the participant is no longer considered a prisoner, 45 CFR 46.303(c) is no longer invoked and the participant may be reintegrated into the research project and resume participation consistent with the IRB approved research. If during the participant's period of incarceration the IRB approved modifications to the research which required re-consent of currently enrolled participants; upon release, if the participant will resume participation they must be re-consented using the most current consent form(s) before resuming participation.

For research involving prisoners, the definition of minimal risk (45 CFR 46.303(d)) differs from the definition of minimal risk for research involving non-prisoners. "Minimal Risk is 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."

• Investigator Prisoner Certification Checklist
  
• Modification Supplement

Instructions

All Clinical Research Division documents must first be routed through the Protocol Office, LM-230.

If prisoners will be engaged in an epidemiological study, please contact the IRO for additional submission requirements.

For New Applications

If the protocol involved is a New Application being submitted for IRB review, append the Investigator Prisoner Certification Checklist along with the New Application form.

• Submission Instructions: Prepare an Investigator Prisoner Certification Checklist. The following information must be explicit and all applicable attachments included.
  • Name of the principal investigator requesting the inclusion of the prisoner
  • Check one of the four categories (A-D)
  • Provide responses to questions 1-6
  • Provide all IRB documents such as the Protocol, Consent/Assent Form(s), questionnaires etc

For Ongoing Studies

If the protocol has been on-going at Fred Hutch, please append both the Investigator Prisoner Certification Checklist and Research Modification Form.

• Submission Instructions: Prepare an Investigator Prisoner Certification Checklist and a Protocol Modification Form, if applicable. The following information must be explicit and all applicable attachments included.
  • IR File Number and Protocol Number (if applicable) of the already approved application
  • Name of the principal investigator requesting the inclusion of the prisoner
  • Check one of the four categories (A-D)
  • Provide responses to questions 1-6
  • Provide all of the most currently approved IRB documents such as th Protocol, Consent/Assent Form(s), questionnaires etc.
  • A completed Research Modification Form, requesting to include a prisoner
    

Please note that all requests to include "prisoners" will undergo Full Review.