Smathers Libraries Assessment and User Experience

IRB-02 Links

• IRB-02 Forms
• Informed Consent Instruction & Procedures
• Investigator Information & Guidelines

Automated Determination Tools for Nonhuman and Exempt Research, and for non-medical Quality Improvement Projects

• University of Florida faculty, staff, and students may use the above linked forms to see if their research qualifies for an automatic determination of nonhuman research, exempt research, or non-medical quality improvement project status. 
• If the project meets the requirements, (1) UF's Division of Research Operations & Services system will email a determination approval to the Principal Investigator and other contacts immediately after submitting the form; and (2) you do not need to submit your project to the IRB for review and approval. 
• Note:  you still need to comply with any other applicable requirements at UF.

All research involving human subjects are subject to IRB review. There are exemptions from requirements for the Code of Federal Regulations (CFR), but any and all research that meets these exemptions must still be submitted to IRB review and oversight. 

Exemptions

• Research conducted in established educational settings, and involving instructional techniques or classroom management methods
• Educational tests, surveys, interviews or observations of public behavior
• Benign behavioral interventions
• Secondary Research involving the access of identifiable data

For a full and complete explanation of each exemption click here

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.