The College of Idaho has determined that research meeting the conditions outlined below is exempt from continuing IRB review. Projects that qualify as exempt must complete the Exempt status form and submit it to the chair of the IRB or a designee prior to the beginning of research. Ongoing review is not required once a determination of exemption is made, unless the research is changed so that it no longer meets the exemption criteria.
There are 6 categories of Exempt Research
To qualify for Category 1 (no age limitations on participants; no restrictions on research methods):
Your research project must involve collecting data in an educational setting to study normal educational practices for the purpose of evaluating instructional strategies (e.g., research comparing those used in normal and special education), instructional techniques, curricula, or classroom management methods.
To qualify for Category 2 (participants must be adults – legal age of adulthood varies by location)
Several types of research projects may fall under this category.
- Studies involving the collection of data using standardized educational tests (e.g., a subtest of an IQ or achievement test);
- Studies involving the observation of public behavior;
- Studies involving the administration of surveys or interviews as long as one of the following conditions is met:
- participation will be completely anonymous OR
- participation is not anonymous, HOWEVER the information that will be gathered would not place participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation;
- Studies involving focus groups as long as the data that is collected (or topics discussed) would be unlikely to place participants at risk (see (c) above).
To qualify for Category 3:
Your research project must meet certain exceptions with respect to the possibility of risk in items c) and d) of the previous category.These exceptions involve participants running for public office and other special groups.
To qualify for Category 4:
Your research project must use existing data or records that are either available to the public (e.g., court records) or data that have been stripped of any direct identifiers (e.g., names, addresses, telephone numbers, social security numbers) and any indirect identifiers (e.g., codes that can be used to link data to participants).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 requirement is that the rights of individuals should be respected; subjects should provide permission for their individually identifiable information to be used for research purposes.
To qualify for Category 5:
This category is limited to very specific types of research or demonstration projects that are conducted by or subject to the approval of federal Department or Agency heads.The following criteria must be satisfied to invoke the exemption under this category:
- the program under study must deliver 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 or demonstration project must be conducted pursuant to specific federal statutory authority;
- there must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB); and
- the project must not involve significant physical invasions or intrusions upon the privacy of participants.
This exemption is for projects conducted by or subject to approval of Federal agencies, and is most appropriately invoked with authorization or concurrence by the funding agency.
To qualify for Category 6:
This category covers taste and food quality evaluations 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 a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
None of the abovecategories apply to Food and Drug Administration (FDA) regulated research.
The Following can NOT be Exempt
- research involving prisoners;
- surveys or interviews of children;
- observation of children when the investigator will interact with them;
- data obtained from adults through administration of educational tests, survey procedures, interview procedures, or by observation of public behavior IF the information is recorded in such a way that the identity of individuals can be identified either directly or through identifiers linked to the individuals AND disclosure of participants’ responses could reasonably place them at risk of criminal or civil liability or be damaging to an individual’s financial standing, employability, or reputation;
- observation of behavior that takes place in settings in which participants have a reasonable expectation of privacy;
- research techniques which expose participants to discomfort or harassment beyond levels encountered in daily life (i.e., greater than minimal risk);
- deception of research participants; and
- research that involves a test article regulated by the FDA unless the research meets the criteria for exemption described in 45 CFR 46.101(b)(6).