Prisoner Certification Checklist for Investigator

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 FHCRC.

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.

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 (Word, 33KB)
• Modification Form (Word, 44KB) updated August 07, 2009

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 James Riddle, IRO Assistant Director at 667-6501 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)
  • On a separate attachment, provide responses to questions 1-6
  • Provide all IRB documents such as the Protocol, Consent/Assent Form(s), questionnaires etc. (For specific instructions and number of copies required for full review submission
  • Provide two (2) copies of any grant proposal(s) funded by the Department of Health and Human Services (HHS)

For Ongoing Studies

If the protocol has been on-going at FHCRC, please append both the Investigator Prisoner Certification Checklist and Protocol 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)
  • On a separate attachment, provide responses to questions 1-6
  • Provide all of the most currently approved IRB documents such as the Protocol, Consent/Assent Form(s), questionnaires etc.
  • Provide two (2) copies of any grant proposal(s) funded by the Department of Health and Human Services (HHS)
  • A completed Protocol Modification Form, requesting to include a prisoner

The IRB now requires ONLY the ORIGINAL DOCUMENTS, including the two copies of any grant proposal(s) as noted in Item F above.

To select a box, double click on the and select "checked" in the "default value" box and click "ok". Use the "track changes" feature to identify changes on one copy, and include a "clean copy" of the document(s). Materials would include the protocol, consent form(s), letters of approach, etc.

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