Although the IRB currently reviews all research involving human participants, federal regulations provide that certain research activities may be eligible for a determination of “exempt” status.
How does the principal investigator apply for Exempt Status?
A principal investigator may request exemption from review by submitting an Application for Exemption IRB Review form. The IRB must be given an opportunity to make such a determination before research can begin. Note: exemption from IRB review does not grant exemption from other federal regulations such as HIPPA requirements for authorization when the research includes an individual’s private health records. If the research does include records that are covered under HIPPA or other federal regulations, then the principal investigator must seek permission from each individual to release these records.
Is the Research Exempt?
- The research is not going to contribute to the general knowledge of a subject area (i.e., it will not be published, presented, or otherwise disseminated outside of the institution in which it is being used).
- The research is being conducted strictly for the improvement, evaluation, or fulfillment of the responsibilities of an institution, department, or office that falls under the regulations of these federal guidelines. The information gathered may not be disseminated to increase the general knowledge of a particular subject area.
- The research does not exceed minimal risk to the human participants. Minimal risk means that the probability and magnitude of harm or discomfort 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.
- The research would qualify for expedited review if it meets the criteria for regulated research (see IRB: Expedited or Full Board Review).