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IRB Oversight Decision Tree
IRB Exemption Screening Checklist
Please read the descriptions below for the three types of review that are conducted by the IRB. Most of the projects being done on campus will fall within one of the 6 Exemption Categories, so be sure to review these descriptions to assist you in determining which type of application to submit.
If you still have questions after reviewing this information, please contact the IRB at firstname.lastname@example.org or at 470/578-2268 for assistance.
1. Exempt Review - research involves no more than minimal risk to participants. Exempt review consists of an initial IRB review, and following classification as exempt, the study is exempted from continuing annual IRB oversight. Please note that all future proposed revisions to an exempted study must be reviewed by the IRB prior to implementation to ensure the study remains exempt. A study is classified as exempt when it falls under one or more of the six categories of exempt research (see below).
2. Expedited Review - conducted when a project involves no more than minimal risk to participants but the project cannot be classified as exempt. Initial review consists of review by the IRB chair and one or more IRB members. The study is subject to continuing oversight by the IRB on an annual basis.
3. Full Board Review - conducted when a project involves more than minimal risk to participants, and initial review includes all members of the IRB. The study is subject to continuing oversight by the IRB on an annual basis. Investigators (and faculty advisors, if applicable) are required to attend the IRB meeting at which the study will be reviewed.
IRB Exemption Categories
Category 1: Educational Purposes Only
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. The research is not FDA regulated and does not involve prisoners as participants.
Category 2: Educational Tests, Surveys, Interviews, Public Observation
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. If the research involves children as participants, the procedures are limited to educational tests and observation of public behavior where the investigators do not participate in the activities being observed. Research is not FDA regulated and does not involve prisoners as participants.
Category 3: Elected or Public Officials
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 public 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. Research is not FDA regulated and does not involve prisoners as participants.
Category 4: Research with Existing Data
Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research is not FDA regulated and does not involve prisoners as participants.
Category 5: Public Benefit or Service Programs
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 programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
Category 6: Taste Tests
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 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. The research does not involve prisoners as participants.