Exemption from IRB Review

Certain research activities may be exempt from IRB review, if approved by the IRB Chair and confirmed in writing to the Principal Investigator. The IRB follows the criteria listed in Federal Regulations 45 CFR 46.101(b) and 21CRF 56.104 when granting exemption to research protocols. The criteria for exemption are as follows:

Research may be exempt from review when the only involvement of human subjects in the research falls into one of the following categories:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
      45 CFR 46.101(b)(1)
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless:
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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.
      45 CFR 46.101(b)(2)
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not otherwise exempt if:
    1. The human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
      45 CFR 46.101(b)(3)
  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 by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. 45 CFR 46.101(b)(4)
  5. 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:
    1. Public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
      45 CFR 46.101(b)(5)
  6. Taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed or
    2. 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.
      45 CFR 46.101(b)(6)