Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 1005 - COLLECTION, DISCLOSURE, AND CONFIDENTIALITY OF HEALTH STATISTICS; INSTITUTIONAL REVIEW BOARD › Subpart B - INSTITUTIONAL REVIEW BOARD › Section 1005.110 - Institutional Review Board Procedures

Current through Register Vol. 48, No. 28, July 12, 2024
a) The IRB review of applications that are
				deemed not exempt or not eligible for expedited review will occur at convened
				meetings subject to the Open Meetings Act. IRB meetings will 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 non-scientific
				areas.
b) The IRB has the authority
				to approve or disapprove, require modification to, or observe research, and to
				suspend or terminate approval (see Section
				1005.130
				). Reliance on another institution's IRB or an independent IRB for review of
				research shall be documented by a written agreement that is available for
				review by federal Office of Human Research Protections upon request.
c) The IRB will provide written notification
				to researchers of approval or disapproval of, or required modifications to,
				proposed research.
d) The IRB Chair
				will review all research applications involving human subjects to determine
				whether the application involves exempt research.
e) The IRB has the authority to allow repeat
				release of designated limited data sets that are not from a HIPAA covered
				program without individualized IRB review.
f) Requests for approval of disclosure of
				health data and approval of research that involves no more than minimal risk to
				human subjects and their privacy and confidentiality are eligible for an
				expedited review procedure. Research projects that are eligible for expedited
				review include those projects found in the list of research categories
				published as eligible for expedited review by the Department of Health and
				Human Services ( 45 CFR 46 ) and previously approved projects for which minor
				changes are proposed during the period for which the IRB has already given
				approval, when those projects or changes involve minimal risk.
g) If a request is eligible for an expedited
				review procedure, the review may be carried out by the IRB Chair or by one or
				more experienced reviewers designated by the Chair from among members of the
				IRB.
h) In reviewing the request
				under an expedited review procedure, the reviewers may approve, but not
				disapprove, the research application. A research application may be disapproved
				only after review in accordance with the non-expedited review procedure.
				Research applications that have been reviewed under, but not approved through,
				the expedited review procedure will be subject to further IRB review at a
				convened meeting.
i) Prior to
				approval, the IRB will determine that all of the following requirements are
				satisfied:
1) Risks to subjects shall be
				minimized; researchers shall use procedures that are consistent with sound
				research design and do not unnecessarily expose subjects to risk;
2) Risks to subjects shall 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 shall be
				equitable;
4) Unless otherwise
				authorized or permitted by law or regulation, informed consent shall be
				obtained and appropriately documented from 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 to be 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 or permitted by law or regulation, the following
				elements of informed consent shall 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 shall make any necessary
				provisions for data monitoring to ensure the safety of subjects;
6) The privacy of subjects and
				confidentiality of data shall be assured;
7) When the research involves subjects likely
				to be vulnerable to coercion or undue influence, additional safeguards shall be
				included to protect the rights and welfare of these subjects.