Exemptions

Certain categories of low-risk research are eligible for an exemption from full review by the UCSC IRB. IRB approval for exempt research does not need to be renewed annually. Decisions about whether studies are exempt must be made by a designated member of the IRB, rather than by the investigator.

Research in which the only involvement of human subjects is in one of the categories listed below qualifies for an exemption from full review provided that the researcher submits and obtains IRB approval of an Exemption Request form.

No research is exempt if any of the targeted populations consists of any persons who are:

• Legally incompetent;
• Significantly mentally ill or impaired; or
• Vulnerable to extraordinary institutional coercion, such as prisoners, residents of 24-hour skilled nursing facilities, or anyone who is involuntarily confined.

Submitting a Request for an Exemption

To obtain and exemption, you must submit a Exemption Request form to the IRB (available on the forms page). Make sure to include on the form enough information about your research to justify the exemption. If your study is determined to be exempt, the UCSC IRB will not further review your project other than confirming that the request for the exemption is granted.

PLEASE NOTE: all procedures for all subjects in a project must be exempt in order for the project to be exempt from full Committee review. 

Exemption Categories

1. Research conducted in established or commonly accepted educational settings that involves 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 institutional techniques, curricula, or classroom management methods.

2. 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 subject; and
(b) any disclosure (including accidental 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.

EXCEPTION: This exemption does not apply to research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

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 Exemption #2 if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statues(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, (a) if these sources are publicly available; or (b) 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.
(Existing means existing before the research is proposed to an IRB).

5. 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 alternative to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without additives are consumed or if a food is consumed that contains a food ingredient at or below the level, and for the 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.

Changes in exempt projects

Investigators should consult with ORCA whenever questions arise about whether planned changes to an exempt study might make that study nonexempt human subjects research.