Subject: Special Categories of Research: Prisoners

Procedure:

1. Investigator Responsibilities.
   1. The Investigator shall describe the target population for the research and provide justification for inclusion of prisoners. If the subject population has an increased potential to become prisoners, and the Investigator shall be interacting, intervening, or collecting identifiable private information during the incarceration, the Investigator may choose to have the research reviewed initially by the IRB and Secretary of DHHS for prisoner participation.
   2. The Investigators shall obtain and provide documentation of approval from the detention or correctional facility involved (i.e., prisons, jails, workhouses, etc.) to the IRB.
   3. The Investigator shall provide any additional documents or materials required for certification to the Secretary of DHHS (through Office for Human Research Protections (OHRP),) for federally funded research involving prisoners.
   4. The Investigator shall not screen, recruit, or enroll any individual involuntarily confined or detained in a penal institution without IRB approval as set forth in IRB Policy VIII.B^[1].
   5. The Investigator shall promptly notify the IRB in writing when a research subject becomes a prisoner after enrollment in research activities. If the research was not reviewed and approved as set forth in IRB Policy VIII.B ¹ all research activities with the now incarcerated prisoner-subject must cease until the requirements as set forth in IRB Policy VIII.B ¹ have been satisfied. However, the subject may continue to participate in the research if the Investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated until all requirements as set forth in IRB Policy VIII.B ¹ are satisfied.
2. IRB Committee Responsibilities.
   1. The IRB will review the proposed research taking into consideration all applicable IRB Policies and Procedures. The IRB will verify that the Committee reviewing the research involving a prisoner has at least one member who is a prisoner or prisoner representative in attendance for all types of review by the convened IRB, including initial review, continuing review, and review of amendments.
   2. The IRB will review and approve research involving prisoners as a target population as set forth in IRB Policy VIII.B. ¹
   3. The IRB will document the discussion in its determination that all seven criteria for approval have been met.
   4. The IRB will inform the Investigator that no prisoner subjects can be enrolled or involved until receipt of a letter from OHRP that acknowledges the prisoner certification and the Secretary's determination that the proposed research is as set forth in Sections II, III of IRB Policy VIII.B. ¹
   5. The IRB will re- review the research when a subject becomes a prisoner as set forth in IRB Policies III.F^[2], and VIII.B. ¹ The IRB will permit the subject to continue to participate in the research if the Investigator asserts that it is in the best interests of the subject to remain in the research study while incarcerated until all requirements in IRB Policy VIII.B ¹ are satisfied.
3. IRB Administration Responsibilities
   1. The Administrator of the IRB will ensure that all appropriate documentation will be provided to OHRP for certification.
4. IRB Specialist Responsibilities.
   1. The Specialist will notify the IRB Committee reviewing the research involving a prisoner to ensure it has at least one member who is a prisoner or prisoner representative in attendance for all types of review by the convened IRB, including initial review, continuing review, and review of amendments.
   2. The Specialist will provide documents to assist the Administrator of the IRB in preparation of the certification letter.

^[1] IRB Policy VIII.B

^[2] IRB Policies III.F