Exempt Review
The regulations for the protection of human subjects define categories of “exemptions.” This means that if the involvement of human subjects will only be in one or more of the exempt categories, the research activities are exempt from the regulations. For studies that may be eligible for exemption if a limited IRB determination is made, the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB will also be assigned to make the limited IRB review determination. At MSU, the investigator may not make the determination of exempt status; the MSU IRB staff, chair, or committee members make the exempt determination.
New Study Submission
The investigator submits a New Study submission through the Click(TM) Research Compliance System, including sufficient supporting documents to make an exempt determination. See the What & How to Submit - Exemption for more information about the submission process.
An IRB administrator will be assigned the study to review. The assigned IRB coordinator will review the submission to determine if the defined project meets the exemption criteria. Clarifications may be requested by the IRB coordinator.
The IRB coordinator may also consult or refer the research study to the IRB chair or members who will make the determination of whether the research meets the exemption criteria. The IRB chair or member may also make the exempt determination when assigned to review expedited or full review research studies.
For studies that may be eligible for exemption if a limited IRB determination is made, the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB will also be assigned to make the limited IRB review determination.
If the research study is determined to meet the criteria for exempt status, the exempt determination letter will be accessible from Click. Please note that an Exempt Determination Letter must be received before any human subject research can begin.
Exempt Categories
To be classified as exempt, the research must meet certain criteria. See the Exempt Categories for the criteria.
Continuing Renewed Approval
Exempt projects do not need to be renewed.
Changes to Limited IRB Review Exempt Research
When a study is determined exempt under a category that involves limited IRB review under the Revised Common Rule (2018 Requirements), certain changes must be submitted as Modifications for IRB review and approval before initiation of those changes.
For Exemption Category (2)(iii) and 3(iii), any proposed change to the provisions to protect the privacy of subjects and to maintain the confidentiality of data, or that may impact those provisions, must be submitted as a Modification for IRB review and approval before initiation of the changes.
Changes to All Exempt Research
With the exception of studies determined exempt under a category that requires limited IRB review as described above, in general, investigators are not required to submit changes to the IRB office once a research study is designated as exempt as long as those changes do not affect the exempt category or criteria for exempt determination (changing from exempt status to expedited or full review, changing exempt category) or that may substantially change the focus of the research study such as a change in hypothesis or study design. If new external funding is obtained for an active human research project that had been determined exempt, a new exempt application will be required, with limited exceptions. This applies to all studies determined exempt.
If the project is modified to add additional sites for the research, please note that you may not begin the research at those sites until you receive the appropriate approvals/permissions from the sites.
Change in Funding
If new external funding is obtained for an active human research project that had been determined exempt, a new initial IRB submission will be required, with limited exceptions.
Reportable Events
If issues should arise during the conduct of the research, such as unanticipated problems that may involve risks to subjects or others, or any problem that may increase the risk to the human subjects and change the category of review, notify the IRB office promptly. Any complaints from participants that may change the level of review from exempt to expedited or full review must be reported to the IRB. Please report new information through the project’s workspace and contact the IRB office with any urgent events. Please visit the Reportable Events page for more information, including timelines.
Personnel Changes
After determination of the exempt status, the PI is responsible for maintaining records of personnel changes and appropriate training. The PI is not required to notify the IRB of personnel changes on exempt research. However, he or she may wish to submit personnel changes to the IRB for recordkeeping purposes (e.g. communication with the Graduate School) and may submit such requests by submitting a Modification request. If there is a change in PI, the new PI must confirm acceptance of the PI Assurance form and the previous PI must submit the Supplemental Form to Change the Principal Investigator with the Modification request.
Closure
When a study is determined exempt under a category that requires limited IRB review under the Revised Common Rule (2018 Requirements), a study closure must be submitted to the MSU IRB. See HRPP Manual 8-9 “Closure” to determine when a study can be closed.
For exemptions that do not require a limited IRB review, investigators are not required to notify the IRB office when the research study is complete. However, the PI can choose to notify the IRB office when the project is complete and is especially recommended when the PI leaves the university.
For More Information
See HRPP Manual 8-1, Exemptions.