Illinois Administrative Code
Title 20 - CORRECTIONS, CRIMINAL JUSTICE, AND LAW ENFORCEMENT
Part 1580 - PROTECTION OF HUMAN SUBJECTS IN RESEARCH CONDUCTED BY THE AUTHORITY
Section 1580.40 - Institutional Review Board Procedures
Current through Register Vol. 48, No. 52, December 27, 2024
a) The general counsel of the Authority shall review all research applications involving human subjects to determine whether the application involves exempt research. If the general counsel determines that the research is exempt, the general counsel shall provide notice of, and justification for, this determination to the IRB members and the executive director of the Authority. If the general counsel does not receive any notice of disagreement with a determination of exempt status from IRB members within 10 working days after the mailing date of the notice, then the determination that the research is exempt will be considered approved by the IRB. If the general counsel receives notice of disagreement with a determination of exempt status from any IRB member, the research will be considered non-exempt and subject to IRB review and approval under this Part. Research projects determined to be exempt are not subject to further IRB review and approval. A determination by the IRB that a research project is exempt is subject to override by the executive director of the Authority.
b) All research applications involving human subjects that do not involve exempt research shall be reviewed by the IRB, in accordance with this Part. The IRB review of research applications must occur at meetings subject to the Open Meetings Act [5 ILCS 120 ]. IRB meetings must include a majority of IRB members who are present at the meeting in person or by electronic means, including at least one member whose expertise is in nonscientific areas. Minutes covering all activities will be taken and made available to the Authority.
c) The IRB shall operate in accordance with all applicable laws and regulations. The IRB has the authority to approve or disapprove, require modification to, or observe research. The IRB must provide written notification to the executive director of the Authority and researchers of approval or disapproval of, or required modifications to, proposed research.
d) The IRB may approve research applications involving human subjects if the IRB has determined that all of the following requirements are satisfied:
e) The IRB may deny requests to conduct the research for reasons including, but not limited to, that the risks posed to human subjects are too great and for noncompliance with applicable laws and regulations. A notice of disapproval must include the reasons for denial in sufficient detail that allows the researcher to respond. The researcher must be given the opportunity to respond to the denial in person or in writing to the IRB.
f) Research subject to this Part must have the approval of a majority of IRB members present at the meeting before data collection may begin.