Exempt Categories
Unless otherwise required by federal department/agency, research activities in which the only involvement of human subjects in research procedures will be in one or more of the following categories are exempt:
Exempt 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices
In order to meet this category, the research cannot adversely impact the students’ ability to learn required material and cannot adversely impact the assessment of educators who provide instruction.
Exempt 2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior
Subcategories:
(i) Information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained
(ii) Disclosure of subjects’ responses outside the research would not reasonably place the subjects at risk
(iii) LIMITED IRB REVIEW REQUIRED - Information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained and disclosure or the responses outside the research could reasonably place the subjects at risk.
Exempt 3. Research involving benign behavioral interventions in conjunction with the collection of information from subjects
Subcategories:
(i)(A) Information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained
(i)(B) Information collection and disclosure of subjects’ responses outside the research would not reasonably place the subjects at risk
(i)(C) LIMITED IRB REVIEW REQUIRED - Information is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained and disclosure of the responses outside the research could reasonably place the subjects at risk.
NOTE: If deception is to be employed when using this Exempt category, the subject must give prospective authorization for the deception. When appropriate, there is an adequate plan to debrief subjects about the true nature and purpose of the research after completing all study activities.
Exempt 4. Secondary research uses of identifiable private information or identifiable biospecimens
Subcategories:
(i) The information or biospecimens are publicly available
(ii) The information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, the investigator does not contact the subjects, and the investigator will not re-identify subjects
(iii) The research use of identifiable health information is regulated under HIPAA. (NOT ABLE TO BE USED AT UCSD)
(iv) The research is conducted by or on behalf of a federal department or agency using government-generated or government collected information obtained for non-research purposes that will be maintained according to certain federal privacy standards
Exempt 5. Federal demonstration projects
Requirements:
- Must be designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs
- Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision
- The research or demonstration project must be published on this list prior to commencing the research involving human subjects
Exempt 6. Taste and food quality evaluation and consumer acceptance studies
Subcategories:
(i) If wholesome foods without additives are consumed
(ii) 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
Limited Review
For exempt categories that require limited IRB review, the IRB must conduct a limited IRB review to make the determination required by the exemption.
Exempt Category Flexibility
When certain criteria are met (e.g. project does not include use of federal funds), a research project that would not otherwise qualify for exempt review through the DHHS or FDA exempt categories may be granted exempt status through OIA’s flexibility initiatives. These initiatives serve to reduce administrative burden on OIA and our researchers while still ensuring the same level of protection for those who participate in research using commensurate protections. For a full listing of our Exempt flexibility initiatives, see our Exempt worksheet.