Investigators may apply to the University Committee on Activities Involving Human Subjects (UCAIHS) for Exempt status if their research falls within certain categories of research considered very low risk under Federal regulation.
The designation of Approved as Exempt may only be made by the UCAIHS, not by the investigator. A full application must be submitted in order for the Committee to determine whether a project should be granted Exempt status.
If granted Exempt status, a project will no longer be under UCAIHS oversight as long as no changes are made to the protocol as Approved as Exempt. If changes are planned, those changes must be submitted to the UCAIHS for review and approval prior to being initiated.
Exempt Research Categories
Categories of research which are exempt include:
- identifiers are not recorded by the PI; or
- there is neither a risk of harm to subjects nor information sought concerning sensitive aspects of the subject's behavior (this does not apply to research involving surveys and interviews with children); or
- there is neither a risk of harm to subjects nor observation of sensitive aspects of the subject's behavior (this does not apply to research with children when the investigator(s) participate in the activities being observed); or
- subjects are public officals or candidates for public office; or
- Federal statute(s) require(s) without exception that confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
- wholesome foods without additives are consumed; or
- a food is consumed that contains a food ingredient at or below the level found to be safe for use by the Food and Drug Administration (FDA) or the Food Safety and Inspection Service of the US Department of Agriculture; or
- a food contains an agricultural chemical or environmental contaminant at or below the level found to be safe for use.
- The study of normal educational practices in commonly accepted educational settings. This includes research of:
Note: The fact that the research takes place in the school does not necessarily mean that Exempt status is appropriate. Activities introduced for the purpose of a study do not constitute normal educational practice.
- regular and special education instructional strategies;
- the effectiveness of or the comparison of instructional techniques, curricula or classroom management methods.
- The use of educational tests, surveys, interviews, or observation of public behavior where:
- The collection or study of existing data (all work with subjects have been completed), documents, records, pathological or diagnostic specimens, where publicly available or where the information is private but identifiers are not recorded by the PI.
- Taste and food quality evaluation and consumer acceptance studies if:
Note: Research (except some projects using existing data) is not eligible for Exempt status if it involves:
- minors (under 18 years of age) except in cases of studies of normal educational practice or collection/study of existing data
- institutionalized mentally disabled people.