Categories of Research Exempt from Further Institutional Review Board Review
An application must be submitted to the committee for approval of exempt status for projects which meet these criteria (see application form). The requirements summarized below are from federal legislation 45 CFR.
- 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 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 the 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 subject at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
N.B.: Exemption number 2 for research involving survey or interview procedures or observations of public behavior does not apply to research involving minors, except for research involving observation of public behavior when the investigator(s) does not participate in the activities being observed.
- 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 number (2) if:
- the human subjects are elected or appointed public officials or candidates for public office; (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if those 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.
- Research activities involving fetuses, pregnant women, human in vitro fertilization, prisoners, or children as subjects are subject to special regulations. Children are defined in the HHS regulations as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” 45 CFR 46.402(a).