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Criteria for exempt and expedited review

Exempt

Research that falls under this category must be reviewed by the IRB, but will be exempted from further IRB review and no additional review will be required for the project unless there are changes in the research protocol. However, before a proposal is exempted from further IRB review, the IRB may request additional information about the proposal, and/or may require changes in the consent form, participant recruitment methods, or other aspects of the procedure. The following are exemption categories:

  1. 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.
  1. 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.
  1. 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 paragraph (b)(2) of this section, if:
  • the human subjects are elected or appointed public officials or candidates for public office; or
  • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  1. 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.

  2. 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.
  1. 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.

Expedited

Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

The categories in this list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects = financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research involving human subjects.