Although the category is called "exempt," this type of research does require the principle investigator to submit a CUHSR application. Only CUSHR can make the determination if a human subject research protocol is exempt from a full review and thus exempt from all the federal regulations regarding human subjects in research. The exempt review process is less rigorous than an expedited or full-committee review. To qualify, research must fall into one of eight (8) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous, publicly-available or de-identified data, or the conduction of very benign behavioral research experiments. The exempt human subjects research must still be conducted in a manner that meets general ethical guidelines such as:
Some of the following factors that may raise questions in the review whether a protocol is exempt or not:
The following are the eight categories exempt research specified by the Department of Health and Human services 45 CFR 46.104
Category 1 Exemption: Normal Educational Practices and Settings
Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2 Exemption: Anonymous Education tests, Surveys, Interviews or Observations
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
Category 3 Exemption: Benign behavioral interventions
Category 4 Exemption: Secondary Research for which consent is not required
Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
Category 5 Exemption: Public Benefit or Service Program
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, 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 programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
Category 6 Exemption: Taste and Food Evaluation and Acceptance Studies
Taste and food quality evaluation and consumer acceptance studies:
Category 7 Exemption: Storage or maintenance for secondary research for which broad consent is required
Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
Category 8 Exemption: Secondary research for which broad consent is required
Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: