INSTITUTIONAL REVIEW BOARD
Federalwide Assurance (FWA): FWA00012669
The IRB Handbook and Submission Forms
The IRB's Handbook for Research with Human Subjects is required reading for UI&U learners, faculty, and staff who are planning a research project that requires IRB approval. The Handbook will introduce you to national criteria for research with human subjects, including informed consent, protected populations, and analysis of risks and benefits. The Handbook also provides detailed instructions on how to prepare an IRB application and the IRB review process.
Decision trees, developed by the Office of Human Research Protections (OHRP) may help you determine what type of IRB review is appropriate for your proposed project. Access the decision trees via the link below.
The Handbook describes how to obtain approval of changes and amendments to your approved study, how to report unanticipated events, and how to obtain a renewal of IRB approval if you have not completed your study within twelve (12) months after the initial IRB approval. You may also request a print copy of the Handbook by contacting the IRB Coordinator.
Some research studies may be exempt from IRB review. Eligible studies must meet specific criteria for exemption from IRB review. Form 626 Claim for Exemption from IRB Review should be submitted, along with a summary of theestudy, as specified on Form 626, to the IRB Coordinator for a determination of eligibility for exemption. The Coordinator will notify researchers whether their studies are exempt via e-mail. Information about the review for exemption from IRB review is available in the revised IRB Handbook.
Form 627 Expedited IRB Review and Form 540 IRB Application and Research Proposal Outline need to be submitted to the IRB Coordinator for studies eligible for expedited review. Studies eligible for expedited review must meet specific criteria. These criteria are available in the IRB Handbook.
Criteria for studies eligible for full review are available in the IRB Handbook.
Access IRB Decision Trees online.
Access IRB Evaluation Worksheet
IRB members use the evaluation worksheet when reviewing proposals. Use the worksheet to evaluate your proposal before submitting it to the IRB. Faculty need to use it to evaluate a learner's proposal before approving it for submission to the IRB.
- IRB Evaluation Worksheet (Word doc)
Access IRB submission forms:
The IRB requires the use of the appropriate format for submitting applications and research proposals for IRB review and approval. Form 540 is the official IRB application and research proposal submission form. Any IRB applications submitted on discontinued forms will be returned to the researcher. Form 540 is available in MSWord format. You can access the form, save it to your computer, insert your information, and then print it or submit it electronically. Submission via e-mail attachment is preferred. The informed consent form outline (Form 495) is also available in MSWord to facilitate electronic submission.
Instructors who assign and supervise learners conducting class-related research projects may submit Form 618 Instructor Class Project Application for IRB review and approval. Results from class-related research projects eligible for Form 618 must be for class-grading purposes only. These projects are not to be used for culminating studies nor to be published or used in professional presentations outside the class environment. Form 620 Class Project Consent Form may be submitted for class-related research projects.
Learners who will conduct class-related research projects, such as independent studies, surveys, questionnaires, or interviews, that will not be used for culminating studies nor published or used in professional presentations outside the class environment may submit Form 619 Learner Application for Class Project for IRB review and approval. An informed consent form template for class projects is available in Form 620.
Researchers whose research projects are not completed within twelve (12) months are required to submit a progress report in order to receive a renewal of IRB approval. The IRB Coordinator will notify researchers via e-mail two months prior to the IRB approval expiration date and will attach Form 628 IRB Continuing Review / Amendments Questionnaire. All forms are also available in the Forms Directory.
Find out more:
Ethical Practice in Research
Informed Consent
CITI Course in the Protection of Human Research Subjects
Other Resources
