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 1005.100 - Institutional Review Board Authority, Role and Composition

Current through Register Vol. 48, No. 28, July 12, 2024
a) The IRB is established by the authority of
				the Department to protect the health and lives of the people of the State and
				to fulfill its duty to comply with all applicable requirements of 45 CFR 46 and
				21 CFR 50 and 56 .
b) An IRB
				approved by the Director shall review requests for health data disclosure for
				which IRB review is required by statute or rule, and proposals for research
				involving human subjects that is conducted by the Department or individuals
				working on behalf of the Department.
c) The Director may require that proposals
				submitted to the Department that have been approved by another IRB be subject
				to review and approval of the Department's IRB.
d) The IRB shall be qualified through the
				experience, expertise and diversity of its members, including race, gender,
				cultural backgrounds and sensitivity to community perspectives. The IRB shall
				review proposed research in light of existing Department commitments, existing
				laws, regulations and guidelines, and standards of professional conduct and
				practice. The IRB will include persons with expertise in these areas.
e) The IRB chairperson will solicit
				recommendations for IRB membership from Department Deputy Directors, IRB
				members, and, as needed, from other Department staff, and professional and
				human services agencies and organizations. Individuals who wish to be
				considered for IRB membership shall indicate their interest by contacting the
				IRB chairperson. The Director will consider the candidates and make formal
				appointments to fulfill the specific requirements of the IRB composition as
				required in this Section and 45 CFR 46.
f) The Director will appoint the IRB members,
				alternate IRB members, IRB Chair, and IRB Vice-Chairs. The IRB will consist of
				at least five members with varying backgrounds. Composition of the IRB will
				reflect the anticipated scope and complexity of review activities, the types of
				populations involved, and the size and availability of Department
				resources.
g) IRB Membership
1) The IRB will not consist entirely of men
				or entirely of women.
2) The IRB
				will not consist solely of members of one profession.
3) The IRB will include at least one member
				whose primary concerns are in scientific areas.
4) The IRB will include at least one member
				who is a non-scientist.
5) The IRB
				will include at least one member who is not otherwise affiliated with, or part
				of the immediate family of, a person who is affiliated with the Department. The
				non-scientist and the member who is not affiliated with the Department may be
				the same individual.
6) An IRB
				member shall not participate in the initial or continuing review of any project
				in which the member has a conflict of interest, except to provide information
				requested by the IRB
.
The IRB Chair shall ensure that IRB members
				with a conflict of interest are not present during IRB votes subject to their
				conflict of interest.
7) The IRB
				may invite individuals with special expertise to assist in the review of issues
				requiring expertise beyond or in addition to that available on the IRB. These
				individuals may not vote with the IRB.