Institutional Review Board Applications

Section 1005.150  Institutional Review Board Applications 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.