Illinois Administrative Code (Last Updated: March 27, 2024) |
TITLE77. PUBLIC HEALTH |
PART1005. COLLECTION, DISCLOSURE, AND CONFIDENTIALITY OF HEALTH STATISTICS; INSTITUTIONAL REVIEW BOARD |
SUBPARTB. INSTITUTIONAL REVIEW BOARD |
§1005.150. Institutional Review Board Applications
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a) Applications for IRB review shall be submitted to the Department electronically unless otherwise requested by the IRB.
b) Applications involving human subjects research shall include the following documentation:
1) A proposal including, but not limited to, the following:
A) The names and curriculum vitae of the principal investigator and co-principal investigators;
B) An abstract of the project;
C) A full description of the project's purpose, methodology, protocol and duration;
D) The number of subjects, the amount of time required for each subject's participation, and a detailed description of the interaction with the subjects;
E) The procedures for obtaining informed consent and the informed consent forms;
F) The questionnaires, testing and measurement instruments;
G) Letters, scripts, posters, notices, flyers, written materials and advertisements to be used for subject recruitment;
H) A duly executed unaffiliated investigator agreement for each investigator who is not an employee or who is not working on behalf of the Department;
I) Proof that each investigator has completed required training in the protection of human research subjects; and
J) The Department resources to be used;
2) Identification of funding resources for the research proposal;
3) Any certifications and assurances regarding the protection of human research subjects, privacy and confidentiality that are required by law or regulation; and
4) Any other information necessary to the IRB review procedure.
c) The IRB will review the application, in accordance with Section
1005.110 and 45 CFR 46.
(Source: Added at 38 Ill. Reg. 19251, effective September 10, 2014)