Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
If you are unsure whether your project is “exempt”, start by asking the following questions:
- Does the project meet the definition of “research”?
- Does the project meet the definition of a “human subject”, such as involving collecting data about living individuals, either through interaction or intervention, or use of identifiable private information or identifiable biospecimens?
If you can say “yes” to both these questions, then your project is considered human subjects research requiring IRB review. The next step is to submit an ORahs protocol application and determine whether your project could be exempt:
- Could my project fall into one of the exemption categories of research?
Below is a quick user reference guide for the exempt categories of research that the UC Santa Barbara Human Subjects Committee reviews:
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Exempt Category 1 - Educational Practices Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: a) research on regular and special education instructional strategies; or b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (45 CFR 46 104 (d)(1)) |
This category does not apply to surveys, interviews, questionnaires, or focus groups which are covered under exempt category 2. The study cannot adversely impact the students’ opportunity to learn required curriculum.
Examples include: A study comparing two curricula being implemented at a school with observation and analysis of class evaluations. A study about professional development workshops. A study evaluating the effectiveness of a commonly accepted math curriculum. A study involving a cooking class in a grocery store. |
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Exempt Category 2 - Educational Tests, Interviews, Surveys, Observation of Public Behavior Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, if at least one of the following is met: a) information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; b) 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; or c) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and if the IRB conducts a limited review for provisions for protecting privacy and maintaining confidentiality (45 CFR 46 104 (d)(2)) |
This category does not apply to interviews or surveys with minors. This category only applies to observation of public behavior involving children if the study team does not participate in the activities being observed. Observations must be of public behavior in a public setting (i.e., park, intersection, parking lot, lobby, etc.) Examples include: An observational study of a pedestrian street crossing where the researcher takes notes of age, gender, clothing of pedestrians. A focus group involving college students and their STEM experiences. An online anonymous survey studying various types of social media use. |
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Exempt Category 3 - Benign Behavioral Interventions with Adults Research involving benign behavioral interventions in conjunction with the collection of information through verbal or written responses or audiovisual recordings if at least one of the following criteria is met: a) information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; b) 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; or c) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and if the IRB conducts a limited review for provisions for protecting privacy and maintaining confidentiality. (45 CFR 46 104 (d)(3)) |
This category does not include minors. Benign behavioral interventions must be brief in duration, harmless, painless and not physically invasive and there is no reason to think the interventions will be offensive or embarrassing. Interventions should not have a last significant adverse impact on the participants. Research involving deception is allowed if the participant is prospectively informed, and agrees to, that they will be unaware of, or misled regarding the nature or purpose of the research. Examples include: A random assignment of participants to take a test under various noise conditions. A study involving randomly assigning participants to various experimental conditions where they decide how to allocate cash between themselves and others. |
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Exempt Category 4 - Secondary Uses of Identifiable Private Information or Identifiable Biospecimens Secondary research for which consent is not required if at least one of the following criteria is met: a) The sources are publicly available; or b) the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects and the investigator does not contact or re-identify the subjects; or c) the research is collected by or on behalf of the federal government using goverment generated or collected information obtained for non-research activities. (45 CFR 46 104 (d)(4)) |
Many projects involving the secondary use of data/specimens do not meet the definition of a “human subject”. This category does not apply to data protected under HIPAA due to UC’s hybrid entity status. This category covers re-using identifiable data collected for some other primary purpose or initial activity, or in other words the data must not be collected for the purpose of the specific proposed study. If access to the data is “limited” or “restricted” then the data set is not likely publicly available. This category covers data analysis from online repositories where users may pay a “user fee” or needs to register to access the data.
Examples include: A study involving secondary research of audio archives in a public library. An analysis of biospecimens from an IRB-approved biorepository. A study involving review of national census data that contains zip codes. |
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Exempt Category 5 - Public Service Projects 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 the following: a) public benefit or service programs; or b) procedures for obtaining benefits or services under those programs; c) possible changes in or alternatives to those programs or procedures; or d) possible changes in methods or levels of payment for benefits or services under those programs. (45 CFR 46 104 (d)(5)) |
This category is limited to programs designated by a federal department head, such as the Secretary of Health and Human Services. The federal entity conducting or sponsoring the research must publish a list of projects that are covered under this exemption on a publically available website prior to commencing the research involving human subjects. This category is rarely applicable to research at UC Santa Barbara.
Examples include: The US Department of Social Security Administration is charged by Congress with providing periodic reports about the effectiveness of access to benefits under the program and SSA contracts with a researcher to collect data for the report. |
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Exempt Category 6 - Taste and Food Quality Evaluation and Consumer Acceptance Studies Taste and food quality evaluation and consumer acceptance studies, if: a) wholesome foods without additives are consumed; or b) 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.
(45 CFR 46 104 (d)(6)) |
This category is rarely applicable to research at UC Santa Barbara.
Examples include: A study involving consumer acceptance of various brands of frozen meals. A study involving a taste-testing of fruit varieties that do not contain additives to determine consumer preference. A study involving taste-testing of various pork products that have been given feed with a chemical additive, if the researcher can document the additive was at or below the levels approved by the USDA. |