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
question #2 above, if: i) The human subjects are elected or appointed public officials or candidates
for public office; or ii) Federal statues(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research and thereafter.
• The research does not involve prisoners as participants.
• The research is not FDA-regulated.
4. Research involving the collection or study of existing data, documents, records, 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 links to the subjects. The data must already exist for a study
that fall into this category. IF the data are not now in existence (e.g. they are yet to be collected), the
study may not be exempted.
• The data, documents, records, and specimens exist at the time the research is proposed.
• The research does not involve prisoners as participants.
• The research is not FDA-regulated.
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:
i) Public benefit or service program; ii) Procedures for obtaining benefits or services under those
programs; iii) 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 program.
• The program under study delivers a public benefit (e.g., financial or medical benefits as
provided under the Social Security Act) or service (e.g., social, supportive, or nutrition
services as provided under the Older Americans Act).
• The research is conducted pursuant to specific federal statutory authority.
• There is no statutory requirement that an IRB review the research.
• The research does not involve significant physical invasions or intrusions upon the privacy of
participants.
• The federal funding agency concurs that this exemption category applies.
• The research does not involve prisoners as participants.
• The research is not FDA-regulated.
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 that contains a food ingredient at 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 US Department of Agriculture.
• The research does not involve prisoners as participants.
Research proposals that do not meet the criteria for an exempt review may qualify for an expedited
review, or will be presented before a full convened board. Protocols that meet the criteria for an
exempt review will be so reported and documented at the next IRB meeting.
