Ill. Admin. Code tit. 20, § 1580.40 - Institutional Review Board Procedures
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.
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.
Notes
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