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. Highlighting each of the categories below will bring up a table listing basic criteria, as well as the appropriate IRB exempt application form.

"Exempt" Research Categories:

• Evaluation of 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
• Medical record review with certified honest broker
• Medical record review by investigator who is part of the UPMC/covered entity workforce
• Research with biological specimens
• Studies Using In Vitro Diagnostic Devices with Specimens that are Not Individually Identifiable
• Data coordinating center or similar ancillary center

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” (see 45 CFR 46.102(d)) and for what is meant by a “human subject” (see 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: The IRB will not provide a formal written determination after the project has been initiated.

The following application will permit the IRB to make this determination:

      • "Request for a Determination that Planned Activity does not Involve Human          Subjects Research"

Note that many specimen studies, medical record reviews, and projects involving existing documents or records may actually meet the ‘no human subjects’ criteria. Please utilize the appropriate “specimen,” “medical record” or “existing data” form, and if appropriate, the ‘no human subjects’ determination will be made automatically by the IRB staff during its review.

General characteristics of all exempt research include the following:

• Private identifiable information cannot be recorded by the investigator or members of the research team if the possibility exists that release of that information could affect the individual’s reputation, employability, or financial status
• Research participants do not sign a consent form but should be informed about the nature of the study via the use of an “introductory script”
• Prior scientific review by a School or Departmental review committee is not required

The review process differs as well. Investigators who believe that their research fits an exempt category must submit a completed application to the IRB (see submission requirements). This is reviewed by the ‘exempt review team’ who determine whether it meets the federal criteria for an exemption, or meet the criteria for “no human subjects” or “not research”. Applications that do not fall into any of those 3 categories will be recommended for either an expedited review (i.e., review by the IRB Chair or designee) – if they meet those specific requirements, or will be recommended for review by one of the weekly convened IRB committees. Please make selections carefully; if an exempt submission is determined by the IRB to require an expedited review, the investigators must submit a new “expedited review” application.

Last Update: November 1, 2007

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