(3)  When a Subject Becomes a Prisoner

(a)  When a previously enrolled human subject becomes a prisoner and the relevant research protocol was not reviewed and approved by the IRB in accordance with the requirements of subparagraphs 7.b.(1) and (2) of this section, the principal investigator shall promptly notify the IRB.

(b)  If the principal investigator asserts to the IRB that it is in the best interest of the prisoner-subject to continue to participate in the research while a prisoner, the IRB Chair may determine that the prisoner-subject may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the IO and DoD Component office review the IRB’s approval to change the research protocol. Otherwise, the IRB Chair shall require that all research interactions and interventions with the prisoner-subject (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol.

(c)  The convened IRB, upon receipt of notification that a previously enrolled human subject has become a prisoner, shall promptly re-review the research protocol to ensure that the rights and wellbeing of the human subject, now a prisoner, are not in jeopardy. The IRB should consult with a subject matter expert having the expertise of a prisoner representative if the IRB reviewing the research protocol does not have a prisoner representative. If the prisoner-subject can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-subject’s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human subjects from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-subject to continue to participate in the research. This approval is limited to the individual prisoner-subject and does not allow recruitment of prisoners as subjects.

(d)  This type of request for change in the research protocol cannot be reviewed and approved by the IRB using expedited review procedures. The research involving human subjects does not have to meet one of the six allowable categories of research as described in subparagraph 7.b.(2) of this enclosure.

(e)  If the research involving human subjects is conducted by a non-DoD institution, the non-DoD institution shall promptly report all decisions in this matter to the HRPO. If the research is conducted by a DoD institution, the IRB shall promptly report all decisions in this matter to the IO and to the DoD Component office conducting the reviews identified in paragraph 3.b. of this enclosure. For all DoD-conducted or -supported research involving human subjects, the applicable DoD Component office conducting the reviews identified in paragraphs 3.b. or 4.c. of this enclosure must concur with the IRB before the human subject can continue to participate while a



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