University of Nebraska Kearney

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UNK
Yellow Hand

Exempt

Exempt review is used for studies presenting less-than-minimal risk to non-vulnerable subjects.

No research is exempt from review; however, research falling into the Exempt category may be exempt from continuing oversight.  Research activities in which the only involvement of human subjects is in one or more of the following categories qualify for review under the Exempt category: 

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

2. Research involving the use of educational tests (e.g. cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) data obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects' responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation. 

Note: When videotaping and/or photography is used for data collection, the research no longer meets the exempt requirements. This is because information is recorded in such a manner that participants can be identified. Audio taping, if used to facilitate accurate record keeping and will be erased following transcription, may qualify for Exempt review. If the recording will be used for purposes that would make the recording part of the reporting process it would not be Exempt. 

3. Research involving survey or interview procedures, except where all of the following conditions exist:  

  • responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the participants;  
  • the participant’s responses, if they became known outside the research, could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant’s financial standing or employability;  
  • the research deals with sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol. 
  • All research involving survey or interview procedures is Exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office. 

4. Research involving the collection or study of existing information, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the investigator cannot identify the participants. 

5. Research and demonstration projects that are conducted by or subject to the approval of supporting agencies, and which are designed to study, evaluate, or otherwise examine: 

  • public benefit or service programs;  
  • procedures for obtaining benefits or services under those programs;  
  • possible changes in or alternatives to those programs or procedures; or  
  • 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, 

  • if wholesome foods without additives are consumed or  
  • 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 and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. 

Note that even if research falls into one of the general categories that is normally exempt, it is not exempt if it involves sensitive topics (e.g., recreational drug use, sexual practices, use of alcohol by minors, criminal behavior) or vulnerable participants (e.g., children, victims, mentally disabled persons).  If you are planning on recruiting subjects from one of these groups, read the information provided on this web site. 

Exempt protocols are first reviewed by the IRB director.  If corrections are suggested, these should be made and the corrected protocol re-submitted to the IRB. No research activities, such as contacting research participants, may be started until you are notified that your project has received IRB approval.