IRB Exemption Categories

It is important to remember that the investigator may not determine on his/her own that the proposed research is exempt from further review.  An application must be submitted to the Institutional Review Board (IRB).

Research Activities that may be Exempt from Further Review

Research involving children¹, fetuses, prisoners, mentally disabled persons, or other adult subjects of diminished autonomy is subject to special restrictions. For adult subjects of undiminished autonomy, capable of making a truly voluntary and uncoerced decision whether or not to participate as subjects in research, the categories of research exempt from further review requirements are:

• Research conducted in established or commonly accepted educational settings involving normal educational practices, such as:
  • research on regular and special education instructional strategies; or
  • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement)  survey procedures, interview procedures or observation of public behavior, unless:
  • information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
  • 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.
• Research involving Benign Behavioral Interventions through verbal, written responses, (including data entry or audiovisual recording) from adult subjects who prospectively agrees and one of the following met:
  • Recorded information cannot readily identify the subject (directly or indirectly/linked);
  • Any disclosure of responses outside of research would not reasonably place subject at risk (criminal, liability, financial, employability, educational advancement, reputation); or
  • The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily ascertained, directly or indirectly through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required.
• 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 by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
• Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, 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.
• 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 or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Footnotes

1. When the human subjects are children, only five of the above categories apply. Exemption 2 (for research involving survey or interview procedures or observations of public behavior), does not apply to research with children, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed. ↩︎