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. 28, July 12, 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:
1) Risks to
			 subjects must be minimized; researchers must use procedures that are consistent
			 with sound research design and do not unnecessarily expose subjects to
			 risk;
2) Risks to subjects must be
			 reasonable in relation to the expected benefits to subjects and the knowledge
			 that may reasonably be expected to result from the research;
3) The selection of subjects must be
			 equitable;
4) Unless otherwise
			 authorized by law or regulation, informed consent must be obtained and
			 appropriately documented for each participating subject or the subject's
			 legally authorized representative. When the IRB determines that the research
			 project must include procedures for obtaining informed consent, the IRB shall
			 ensure that informed consent is obtained under circumstances and through
			 procedures that adhere to all applicable laws and regulations, and minimize any
			 coercion or undue influence upon the subject or representative. Unless
			 otherwise authorized by law or regulation, the following elements of informed
			 consent must be provided to each human subject:
A) An explanation of the purposes of, and
			 procedures involved in, the research and the expected duration of the subject's
			 participation;
B) A description of
			 any reasonably foreseeable risks or discomforts to the subject;
C) A description of any benefits to the
			 subject or to others that may reasonably be expected from the
			 research;
D) A statement describing
			 how the confidentiality of records identifying the subject will be
			 maintained;
E) Information
			 regarding who should be contacted for answers to questions about the research
			 and research subjects' rights and in the event of a research-related injury to
			 the subject;
F) A statement that
			 participation is voluntary, refusal to participate will involve no penalty or
			 loss of benefits to which the subject is otherwise entitled, and the subject
			 may discontinue participation at any time without penalty or loss of those
			 benefits; and
G) Any additional
			 information that the IRB determines would further protect the rights and
			 welfare of the subject;
5) The research must make any necessary
			 provisions for data monitoring to ensure the safety of subjects;
6) There are adequate provisions for assuring
			 the privacy of subjects and confidentiality of data;
7) When the research involves subjects likely
			 to be vulnerable to coercion or undue influence, additional safeguards must be
			 included to protect the rights and welfare of these subjects; and
8) The research must comply with applicable
			 laws and regulations.