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.
If your Exempt study is archived, you can continue conducting research activities as the IRB has made the determination that your project met one of required exempt categories. The only caveat is that no changes can be made to the application. If a change is needed, you will need to submit a NEW Exempt application.
IRB Determination That This Study Is Either Not Research or Does Not Involve Human Subjects
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.
Exempt Application Forms
The IRB has developed guidance documents and application forms for the most commonly requested exemptions as noted below. 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 at email@example.com.
- Educational Strategies, Curricula, or Classroom Management Methods
- Tests, Surveys, Interviews, or Observations of Public Behavior
- Existing Data or Research Records (not applicable for medical record reviews)
- Retrospective Medical Record Review
- Research with Biological Specimens
- Request for an Exception to Informed Consent Requirements:Studies Using In Vitro Diagnostic Devices with Specimens that are NOT Individually Identifiable
- Determination that Research Does Not Involve Human Subjects or Is Not Research
If you have any questions, email firstname.lastname@example.org