Federal guidelines and the Davidson College IRB policy permit certain types of research to proceed without IRB approval. The determination as to whether any particular research project qualifies as "exempted" must be made by at least one IRB member. Investigators may not self-determine that his or her own research protocol qualifies for exemption from IRB review. Investigators who believe their research projects should be classified as "exempted" (see categories below) must submit an IRB Application for Exempt Research (DOC) to the IRB, paying special attention to the submission checklist on the last page of the protocol application to ensure that the protocol submission is complete. A Notification of Approval of Exemption Request signed by the IRB Chair or Vice Chair must be received in response to the submission before research can begin.
IRB Exemption Categories (Exempt Status Decision Tree)
Research activities in which the only involvement of human subjects will be in one or more of the following categories may be given a determination of exemption. If your research involves children (under age 18), exemption categories are limited*.
1. Title 45, Code of Federal Regulations 46.101(b)(1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(i) research on regular and special education instructional strategies, OR
(ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
2. Title 45, Code of Federal Regulations 46.101 (b)(2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND
(ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Title 45, Code of Federal Regulations 46.101 (b)(3): 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 category 2, if:
(i) the human subjects are elected or appointed officials or candidates for public office; OR
(ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Title 45, Code of Federal Regulations 46.101 (b)(4): 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.
[NOTE: Exemption Category #5 does not apply to Davidson College and, therefore, is omitted from this list.]
6. Title 45, Code of Federal Regulations 46.101 (b)(6): Taste and food quality evaluation and consumer acceptance studies,
(i) if wholesome foods without additives are consumed; OR
(ii) if a food is consumed which contains a food ingredient at or below the level and for a use 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.
*Limitations on Exemptions
Research involving minor children may be exempt only as it applies to categories 1, 3, 4, and 6 above. Research involving minors which fall under category 2 may be exempt for educational tests and observation (when the investigator does not participate in the activities being observed). Research involving survey or interview procedures may not be exempted for minors.