Research that Qualifies for Exemption from Federal Regulations for the Protection of Human Subjects - Code of Federal Regulations, Title 45 CFR 46.101
45 CFR 46.101 (b)(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
45 CFR 46.101 (b)(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures 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.
45 CFR 46.101 (b)(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 (b)(2) of this section, 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 the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
45 CFR 46.101 (b)(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)(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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
45 CFR 46.101 (b)(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.
Exemptions at 46.101(b)(1) and (b)(3) through (b)(6) are applicable to research studies that use children as subjects. The exemption at 46.101(b)(2) regarding educational tests is also applicable to research involving children as subjects. However, the exemption at 46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research involving children as subjects, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed (45 CFR 46.401 (b)).
Exempt studies do not require continued IRB monitoring. However, any revisions made to exempt research must be approved by the IRB before their implementation. The principal investigator may not begin the research study until he/she receives written confirmation that the research meets exemption criteria.
The following research activities do not qualify for exemption: