IRB Exempt Research
Projects that qualify for exemption under the federal regulations are reviewed by the IRB through the Exemption Certification application process. If the IRB determines that the project is eligible for exemption and that the research protocol includes appropriate protections for the human subjects, the project is exempt further review for three years as long as there are no changes to the research protocol.
Research activities are exempt when the project involves not greater than minimal risk and when the only involvement of human subjects falls within one or more of the following categories. Research involving greater than minimal risk or involving any activities that fall outside these categories must be reviewed by the IRB through expedited or full review procedures.
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special educational instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- 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. PLEASE NOTE: Subpart D amends this exemption, in part: If the subjects are children, research involving interview or survey procedures and research involving observations of public behavior in which the researcher(s) participate in the activities being observed are not exempt.
- 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 (b) of this section, if: 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 involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, 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 identifiers linked to the subjects. PLEASE NOTE: According to the Office for Human Research Protections (OHRP), “to qualify for this exemption the data, documents, records, or specimens must be in existence before the project begins. The principle behind this policy is that the rights of individuals should be respected; subjects must consent to participation in research.”
- 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.
- 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.