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What process is followed for an exempt review?

If your research meets criteria that qualify for an exempt review, you must submit an application for exemption. To apply for an exempt review, the Principal Investigator must submit a complete application to Research Compliance Office through the eProtocol system. This includes all supporting documentation such as:

  • Protocol
  • Consent forms
  • Surveys or interview questions
  • Test forms
  • Subject screening forms
  • Recruitment materials (posters, phone scripts, etc.)
  • Letters of agreement, or other supporting documentation to assure the IRB that appropriate coordination has been done with outside organizations or institutions (clearances to perform research or distribute surveys, etc., at any facility or institution where the research will be conducted).

Do I need to let the IRB know if my exempt study changes?

Yes. If your exempt study changes you must notify the administrative office of the IRB for confirmation that the change has not changed the exempt determination status.

To apply for exempt verification, e-mail all documents to either the umksssirb@umkc.edu or umkcahsirb@umkc.edu. The attachments must be complete and consistent.

Wait for written IRB approval before beginning data collection.

Sponsorship: For student research applications, the Principal Investigator must be UMKC faculty.

Does your research or project qualify for an “Exempt” determination?

Some research projects using human participants raise no substantial risk to subjects. To qualify for an exempt review process, your research must involve no more than minimal risk (summarized as no greater risk than that encountered in everyday life) and fall under one of the following categories:

  1. Research conducted in established or commonly accepted educational settings, involving normal education practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

    NOTE: Research in this category may include minors. However, if the research introduces instructional strategies that are not commonly used and well accepted or adds assessment procedures that are not routinely used, it does not fit in this category.

  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior unless:

    • (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and 
    • (ii) any disclosure of the human subjects’ response outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

    NOTE: Surveys or interviews with children are never exempt. In addition, observations of the public behavior of children are not exempt if the observer participates in the activities being observed.

  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under (#2) of this section, is exempt if:

    • (i) the human subjects are elected or appointed public officials or candidates for public office; OR
    • (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter.

       

  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded in such a manner that subjects cannot be identified, either directly or through identifiers linked to the subjects.

    NOTE: Please note that to qualify for this category all data, documents, records, or specimens to be used in the research must be in existence at the time of IRB review and must have been collected for purposes other than the proposed research.

  5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads which are designed to study, evaluate, or otherwise examine:

    • (i) Public benefit or service programs;
    • (ii) procedures for obtaining benefits or services under these programs;
    • (iii) possible changes in or alternatives to those programs or procedures; OR
    • (iv) possible changes in methods or levels of payment for benefits or services under those programs.

       

  6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Are there conditions that prohibit the use of an exempt review? Yes. Examples include research or studies that:

  • Involve more than minimal risk to the participant.
  • Place identified participants at risk of criminal or civil liability or economical or social damage.
  • Involve prisoners, pregnant women, fetuses, neonates, (or others requiring special protections).
  • Some research involving children. For example, an exempt process is prohibited if the investigator participates in proposed research activities with children.
  • Use surveys or interviews that pose questions of a very personal and/or sensitive behavior.