1. a) Applications for IRB review shall be submitted to the Department electronically unless otherwise requested by the IRB.
2. b) Applications involving human subjects research shall include the following documentation:

3. 1) A proposal including, but not limited to, the following:

   1. A) The names and curriculum vitae of the principal investigator and co-principal investigators;
   2. B) An abstract of the project;
   3. C) A full description of the project's purpose, methodology, protocol and duration;
   4. 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;
   5. E) The procedures for obtaining informed consent and the informed consent forms;
   6. F) The questionnaires, testing and measurement instruments;
   7. G) Letters, scripts, posters, notices, flyers, written materials and advertisements to be used for subject recruitment;
   8. 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;
   9. I) Proof that each investigator has completed required training in the protection of human research subjects; and
   10. J) The Department resources to be used;
   11. 2) Identification of funding resources for the research proposal;
   12. 3) Any certifications and assurances regarding the protection of human research subjects, privacy and confidentiality that are required by law or regulation; and
   13. 4) Any other information necessary to the IRB review procedure.
4. 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)