Categories of Research Exempt from Committee Review
45 CFR 46 101(b)

1. Instructional Research in Educational Settings
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(a) research on regular and special education instructional strategies, or
(b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

This category may be applied to research involving children.

2. Surveys/Interviews; Standardized Education Tests; Observation of Public Behavior
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 could reasonably place employability, or reputation.

Surveys on sensitive or personal topics that may cause stress to study participants are not exempt from IRB review.

This section pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity. This section is not applicable to survey or interview research involving children.

3. Public Officials; Surveys/Interviews; Educational Tests; Observation of Public Behavior
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior 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.

4. Existing Data; Records Review; Pathological Specimens
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 in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

To qualify for this exemption ALL of the data, documents, records, or specimens must be in existence before the project begins.

Records considered private based on federal and state statute, including medical records and education records, require written release by the study subject or by the custodian of the record. Researchers are cautioned that review of private records involving access to and/or recording of identifiable information is not exempt from IRB Review and requires written consent of the study subject. Review of existing public records do not require prior consent of subjects.

Pathological or diagnostic specimens that are considered waste and are destined to be destroyed can be used in research and are considered exempt from IRB review if there are no patient identifiers linked to the specimen and if the data is not intended to be used in the diagnosis or treatment of a patient. (If either of these conditions apply, consent of the research subject and IRB review is required.) Specimens retrieved as extra during a clinical procedure require IRB review and written consent from the subject.

Inclusion of fetal tissue in the pathological specimens category of exempt research is prohibited by regulation.

5. Public Service Programs; Demonstration Projects
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 of 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.

6. Taste Testing and Food Quality Evaluation
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 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.

This category may be applied to children; however, College policy requires written parental consent to include children in taste testing studies.