Applying for an IRB Exemption
Applicants requesting an IRB exemption should note that “exempt” doesn’t mean the IRB won’t review the application at all, nor does it mean the applicant is free from all obligations of human subjections requirements, such as informed consent, or in some cases, the human subjects protection training. It basically means the project is exempt from an expedited or full review by the IRB.
Based on federal guidance on exemptions and Texas State UPPS 02.02.03, the Texas State IRB, not the individual performing the research or project in question, decides whether a project is exempt from an expedited or full review. The exemption application module has been provided to ease, and hopefully hasten, that process.
The six federal categories of exempt research, can be found at CFR 45, part 46, Sec.(b).
Applicants requesting an exemption based on one of these categories will need to cite the category and provide a brief explanation of how it applies to their research project.
The Texas State IRB does not have the authority or intent to modify or add to the categories of exempt research in the federal regulation. However, there are some applications submitted to the IRB that may not qualify as “research,” or have such a limited scope that they pose slight, if any, risk to participants and thus may not be subject to an expedited or full review by the IRB. The Texas State IRB may also designate these projects as exempt.
Conversely, some projects, while technically exempt under the federal regulations, may be found to pose some risks to human participants and the IRB may choose to perform at least an expedited review of these and require further action from the applicant.
So, in summary, in some instances, when granting exempt status, the IRB may make recommendations to the applicant, require human subjects protection training, suggest training on an informed consent preparation module or some similar action designed to protect the safety of the human subjects in the project.
If, after applying for exemption, the applicant’s project is found to be not exempt, the applicant will be required to take the human subjects protection training and the IRB will request additional standard IRB documentation. We will make all possible efforts to place the applicant's request into the currently-scheduled IRB review cycle.
Return to the IRB Exemption Request Module
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