Reference for Determining Exempt Categories (from 45 CFR 46.101)
The federally approved categories for exempt level research are listed below. If your research falls into more than one of these categories, please check all the categories your research applies to. If your research does not fall into any of these categories, you may need to complete an expedited/full board application for your proposal.
Instructional Strategies in Educational Settings: this includes 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.
Surveys/Interviews; Standardized Educational Tests; Observations of Public Behavior: These are exempt from federal policies, unless both of the following conditions exist:
- Responses are recorded in such a manner that the participants can be identified, directly or through identifiers linked to the subjects
- The subject’s responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation
Public Officials -- Surveys/Interviews; Observations of Public Behavior: If all of the preceding conditions exist, your proposal may still be considered exempt if you meet either of the following conditions:
- The human subjects are elected or appointed public officials or candidates for public office
Existing Data; Records Review; Specimens: Research involving these sources is exempt 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.
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:
- Public benefit or service programs
- Procedures for obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures
- Possible changes in methods or levels of payment for benefits or services under those programs
Taste Testing and Food Quality Evaluation: Proposal under this category are exempt if:
- Wholesome foods without additives are consumed
- 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