Review Categories

Proposals are exempt from federal regulations NOT from IRB review.  Exempt research poses no more than minimal risks (risk level similar to what is encountered in everyday activities) to subjects and proper procedures are used to implement ethical principles for the protection of human subjects. The IRB staff determines whether a research project will undergo an exempt review. As necessary, the chair or designee will consult with other IRB members when making this decision.

The following types of research may fall into the exempt category:

• Anonymous survey/interview procedures or observation (without intervention) of public behavior;
• Survey/interviews in which the participant cannot be linked and information obtained is innocuous. Disclosure of this information would NOT reasonably place the participant at risk of criminal or civil liability or be damaging to the participants? financial standing, employability or reputation; and/or
• A project using existing data or pathological specimens providing the information is recorded anonymously.

The expedited review category is used for certain types of research involving no more than minimal risk, as well as for minor changes to research previously approved by the full committee during the period for which approval has been authorized. Proposals can be reviewed by one or more members of the University's IRB. Reviewers may refer the proposal to the full committee. The following types of research may fall into the expedited review category (See 45CFR46 for a more detailed description of OHRP Expedited Categories):

• Surveys which can be linked to participant and may request "sensitive" information;
• Blood draws; Non-stressful research on individuals or group behavior;
• A project using existing data or pathological specimens if the information recorded can be linked to participant
• Recording of data using non-invasive procedures; and/or
• Surveys which can be linked to participant and may request "sensitive" information.

Any research not covered under the exempt or expedited review categories is referred to the IRB for full committee review. The PI will be invited to attend the IRB committee meeting. The committee will either: (i) approve the research as written or pending specific minor changes; (ii) require modifications to secure approval; or (iii) table the research. The committee will notify the principal investigator in writing about the committee's decision. The following types of research may fall into the full committee review category:

• Invasive medical treatments;
• Physical or psychological risk;
• Special populations (minors, pregnant women, prisoners, incompetent participants); and/or
• Criteria for exempt or expedited review are not met.

Not Human Subject's Research: Any project that does not meet the definition of research usually are Quality Improvement Projects

• It has been determined that this project does not meet the definition of research under 45 CFR 46.102(d). IRB review is not required
• This project does not involve human subjects under 45 CFR 46.102(f). IRB review is not required.