Exempt Review Categories
Investigators are eligible for an exempt IRB review if the only involvement of human subjects in your proposed study is in one or more of the following categories listed below. If any part of your study requires a higher level of review, then an expedited/full review application should be submitted.
- Be sure to consider if your study is subject to more stringent requirements imposed by other organizations, such as the Food and Drug Administration, the National Institutes of Health, other sponsors, or state or local governments before submitting an exempt review application.
The following categories of research are currently approved for exemption:
Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, research on the effectiveness of the comparison among instructional techniques, curricular, or classroom management methods.
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) IF (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects OR (ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection IF (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects AND (ii) Any disclosure of the human subjects' responses outside of research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
Secondary research (study of existing data including documents, records, or biospecimens) for which consent is not required; AND IF (i) The identifiable private information or identifiable biospecimens are publicly available; OR (ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; OR (iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated for the purposes of "health care operations" or "research" or for "public health activities and purposes;" OR (iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities.
Research and demonstration projects which are conducted by or subject to the approval of appropriate Federal Department of Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; OR (ii) procedures for obtaining benefits or services under those programs; OR (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.
Taste and food quality evaluation and consumer acceptance studies if the food has been found to be safe by the FDA or other food safety agency.