Human Subjects Protection
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IRB Exemption criteria

 Exempt Review – Exempt research is research with human subjects. However, it is "exempt" from the provisions stated in 45 CFR 46, Subpart A (Common Rule). An exempt research project does not require ongoing review from the IRB unless the project is amended in such a way that it no longer meets the exemption criteria. (However, institutional policy may have different requirements for obtaining consent as well as continuing review of exempted protocols. Student investigators should consult with their IRB regarding these matters.) The IRB is required to determine if a research project falls under one of the following six exempt categories listed in the federal regulations (45 CFR 46.101(b)):

 

  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 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, 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.
  3. 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 (2) if:
    1. The human subjects are elected or appointed public officials or candidates for public office, OR
    2. The research is conducted for the Department of Justice under Federal statute 42 U.S.C. 3789g, or for the National Center for Education Statistics under Federal statute 20 U.S.C. 12213-1, which provide certain legal protections and requirements for confidentiality 
  4. Research involving the collection or study of existing data, documents, records, 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 department or agency heads, and which are designed to study, evaluate, or otherwise examine:
    1. Public benefit or service programs, OR
    2. Procedures for obtaining benefits or services under those programs, OR
    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.
  6. Taste and food quality evaluation and consumer acceptance studies, if:
    1. Wholesome foods without additives are consumed, OR
    2. 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 U.S. Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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Last Updated: 6/5/14