Under 45 CFR 46.101(b), the federally approved Categories of Exemption are listed below.
- Research conducted in established or commonly accepted educational settings involving normal educational practices, such as: (a) research on regular and special education instructional strategies; (b) research on the 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: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) any disclosure of the human subjects’ responses outside the research reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 if: (a) the human subjects are elected or appointed public officials, or candidates for public office, or (b) 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 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.
- 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: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies: (a) if wholesome foods without additives are consumed, or (b) if a food is consumed that contains a food ingredient or 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 U.S. 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.
Under 45 CFR 46.101(b), the following are required for exempt research:
a) deception of subjects is not an element of the research;
b) all subjects are over the age of eighteen;
c) the activity does not expose the subject to discomfort or harassment beyond levels encountered in daily life;
d) subjects are not fetuses, pregnant women, human in vitro fertilization, children, or individuals involuntarily confined or detained in penal institutions.
Exempting an activity from review does not absolve the investigator(s) of the activity from ensuring that the welfare of subjects in the activity is protected and that methods used and information provided to gain subject consent are appropriate to the activity.