Introduction to Exempt Review
The Code of Federal Regulations, Title 45 CFR Part 46, identifies several different categories
of minimal risk research as being exempt from Federal Policy for the Protection
of Human Research Subjects.
Prior scientific review by a School or Departmental review committee is not required.
Applications that do not meet the criteria for exempt review will be recommended
for either an expedited review or for review by a convened IRB committee. Please
make selections carefully; if an exempt submission is determined by the IRB not
to meet this criteria, you will be asked to withdraw the application and submit
a NEW STUDY.
The IRB does not actually approve an exempt study but instead makes a determination
that the project meets at least one of the federal exempt categories criteria. Therefore,
annual review is not required and no expiration date will be listed on your approval
letter. It is also very important that you close-out your project when completed
or if you leave the university. Faculty mentors are responsible for oversight of
student projects and should ensure exempt studies are completed and closed-out in
OSIRIS before the student leaves the university.
IRB Determination That This Study Is Either Not Research or Does Not Involve Human
The federal regulations include a very specific definition for what constitutes
“research” (45 CFR 46.102(d)) and for what is meant by a “human
subject” (45 CFR 46.102(f)). Often investigators will require that
a formal determination from the IRB be made that their project either is not research
and/or does not involve human subjects (e.g., as may be required by a student’s
doctoral dissertation committee, a funding agency, or a journal editor). Note that
many specimen studies, medical record reviews, and projects involving existing documents
or records may actually meet the “no human subjects” criteria. The IRB
will not provide a formal written determination after the project has been initiated.
Note that many specimen studies, medical record reviews, and projects involving
existing documents or records may actually meet the “no human subjects”
criteria. If you do not submit the Not Research or Does Not Involve Human Subjects
application but your project meets this criteria, the IRB will issue this determination
in writing during its review.
The IRB provides a consultation service to the research community and we strongly
encourage you contact the IRB with any questions or concerns. Email us at
firstname.lastname@example.org to schedule a consultation with a member of the IRB staff.
Since OSIRIS is internet-based, we can view your study before it is even submitted
for review. This allows us to perform a pre-review if needed before the PI actually
submits the project for review. We recommend that you make an appointment but same
day appointments are certainly possible. If you are student or plan on conducting
research in a foreign country, you are strongly encouraged to schedule a consultation
early in your planning stage.
To facilitate our efficiency, and to optimize service, we encourage investigators
to utilize e-mail for all queries. Messages will be reviewed frequently by the IRB
staff, who will respond either by e-mail or phone, depending on the nature of the
question. If you have worked with an IRB staff previously, feel free to contact
that person directly if you have questions about your existing project they reviewed
or as a resource for future projects. Click on the “Contact Us” link
for a complete listing of IRB staff.
The IRB has developed guidance documents and application forms for the most commonly
requested exemptions as noted below. The exempt forms are also available under the
IRB Forms section. You will be required to download one of the exempt forms, save
to your computer, complete and then upload the form in question E2.0 in OSIRIS.
If you are unsure which form to complete, contact an IRB staff member or email us
OSIRIS - Online Submission for Institutional Reviews
Instruction Sheet for Exempt Applications
If you have any questions, email the support team at email@example.com.