Excluded Projects

Not all projects involving human subjects or biospecimens require IRB review and oversight.  However, the Office of Human Research Protection discourages individuals planning projects involving human subjects from making this determination themselves.  Lawrence has developed a process for researchers to quickly determine if their project is excluded by completing the short Request to Determine Exclusion from IRB Review form that can be found under the Forms and Templates tab to the left.  Once you have submitted the form the IRB will get back to you within 3 business days with a determination.

Projects Requiring IRB Review

If your research requires IRB review, your project will be reviewed in one of three ways depending on the way you plan to engage human subjects: 1) Exempt Review, 2) Expedited Review, and 3) Full Review.

While exempt and expedited review usually takes less than a week, a full review will require two weeks or perhaps more.  It is common that even exempt and expedited projects require some minor changes before they are approved.  Thus it is very important to submit your protocol well in advance (and no less than two weeks) of your planned start date.

1. Exempt Review

Projects that present only minimal risk to their subjects and that do not involve deception or human subjects that are not able to provide informed consent may not require ongoing IRB oversight.  These projects are called "exempt" because they are exempted from continuing oversight, not because they are exempt from IRB review.  Most student projects are determined to be exempt from further IRB oversight.  Exempt research is defined under 45 CFR 46.104.  Exempt projects will be reviewed by the Chair of the IRB, and usually takes 3 to 5 business days.

2. Expedited Review

Research involving no more than minimal risk to human subjects, but that is not among the specific categories of research defined as exempt under 45 CFR 46.104 is given expedited review.  These projects are typically sent by the IRB Chair after initial review to one of the IRB members for formal reviewed in lieu of sending it to the full board. Some student projects fall under this category.  Expedited review typically takes 5 to 10 business days.

3. Full Review

Any project that MAY present greater than minimal risk or that involves subjects who MAY not be able to provide informed consent must be reviewed by the full board. After initial review, the IRB Chair convenes the full IRB to discuss the risks vs. benefits of the research and to assure that the protocol is compliant with federal regulations.  Research involving children must be reviewed by the full IRB.  Many international projects require full IRB review because of the challenges involved in obtaining informed consent in different languages and cultural contexts.  Research with at-risk populations or involving topics that may harm subjects if they become known (e.g. drug abuse, sexual behavior, criminal activity, health problems, etc.) usually requires full IRB review.  Full IRB review will take at least two weeks. 

What is minimal risk?

“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” (45 CFR 46.102)