Determining if a Project is Exempt, Expedited, or Requiring Full Board Review
There are three levels of IRB review: Exempt, Expedited, and Full Board Review. Please read about all three before making a determination about your specific project.
If you are still unsure about a specific project, contact the IRB Chair for assistance.
Research that is classified as Exempt will not require any further review after the initial approval and only needs to be reviewed by the chair of the IRB.
Categories of Research that qualify as Exempt:
1. Research conducted in established or commonly accepted
educational settings, involving normal educational practices, such as (i)
research on regular and special education strategies, or (ii) research on the
effectiveness of or the comparison among instructional techniques, curricula, or
classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures [if minors are involved, Full Board review is required], interview procedures [if minors are involved, Full Board review is required], 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' responses 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.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is NOT already Exempt under #2 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 confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, or pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of [Federal] Department or Agency heads and 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) 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.
Research that is classified as Expedited only needs to be reviewed by the chair or by a qualified member of the IRB that has been designated by the chair. It is, however, subject to annual review.
A research project is appropriate for Expedited review if it involves only minimal risk, but is not classified as Exempt. Minimal risk is defined as risk that is not greater than what one encounters in ordinary daily life or during the performance of routine physical or psychological examinations or tests.
If your project involves more than minimal risk to participants as defined previously, your project requires a Full Board review. Protocols involving any of the following will also require Full Board review:
1. Minor subjects (children 17 years of age or younger)
2. Special populations (prisoners, pregnant women, individuals with disabilities)
3. The use of video- or audiotape to record subjects
4. Asking questions that may be highly embarrassing or compromising (e.g., sexual behavior, sexual orientation, alcohol consumption, illegal drug use, medical conditions, violations of the law, personal finances, problems in the workplace, etc.)
5. Exposing subjects to graphically violent or pornographic materials
6. Inflicting physical pain upon, attaching electrodes to, or injecting any substance into subjects
7. Creating high levels of stress, fear, discomfort, or tension
8. Threatening subjects in any way
9. Causing subjects to violate laws or official university regulations
10. Providing some subjects with benefits denied to others (this includes payments or rewards for participation, e.g., offering extra credit to participants, etc.)
11. Causing physical or mental exhaustion or engaging subjects in intense exercise
12. Placing individuals in confining physical settings or attaching other devices
13. Exposing subjects to extreme conditions (e.g., bright lights, loud noise, intense pressure, strong odors, complete darkness, extreme heat or cold, sudden movement, etc.)
14. Leaving subjects alone for periods of time longer than 20 minutes
15. Taking hair samples or nail clippings from subjects
16. Taking human tissue samples, drawing blood, or sampling any other bodily fluid
This page was last updated by Ryan Martin, September 10, 2008