Levels of Review
Non-human Subjects Research
If a project meets the definition of research, but does not include a human subject, it falls under a category of review called “not human subjects research.” The IRB can complete a formal review of projects like this through the eProtocol form, which provides the researcher a determination letter. While the IRB makes this determination optional, some Departments or organizations require that research conducted with their support complete this step.
Exempt
Human subjects research activities that fall under a list of categories that are identified as particularly low risk are considered exempt from Common Rule regulation (the rules governing IRB review and approval). For research to qualify as exempt, it must meet the definition of “minimal risk” and fit within one or more of the Exempt research categories.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Exempt Category 1:
Research into educational practices: Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or assessment of educators who provide instruction such as:
- research on regular and special education instructional strategies; or
- research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods
Examples
- A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, researchers will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
- A study comparing two curricula that are currently being implemented in a school. Researchers will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
- A study comparing driver’s education curricula offered by area driving schools. The researcher will observe classes and compare group driving test scores at the end of the courses.
Exempt Category 2:
Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
Examples
- A study involving a survey regarding workplace satisfaction at area firms.
- An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
- A study involving interviews with college seniors (age 18 and older) about their plans after graduation.
- A study involving focus groups with expectant mothers regarding their perceptions of parenting education.
Exempt Category 3:
Benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses or audiovisual recording if the subject prospectively agrees. The interventions must be brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator must have no reason to think the subjects will find the interventions offensive or embarrassing.
Examples
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A study that involves asking subjects to play an online game that takes 30 minutes to complete.
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A study that involves asking subjects to solve puzzles under various noise conditions that don’t present a risk of harm or pain. Study procedures take about 2 hours.
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Healthy adult subjects are asked to take part in two 2 hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software.
Exempt Category 4:
Secondary research uses of identifiable private information or identifiable biospecimens.
Examples
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A research study of treatment outcomes for a certain drug that involves the review of patient charts at a medical facility.
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A student will be given access to data from her faculty advisor’s health survey research project. The data consists of coded survey responses, and the advisor will retain a key that would link the data to identifiers. The student will extract the information she needs for her project without including any identifying information and without retaining the code.
Expedited
Human subjects research that is minimal risk but does not fall under an exempt category, may be considered for Expedited review if all the research activities can be included in several specific categories.
Full Board
Human subjects research that does not fit under an Exempt or Expedited category, or presents greater than minimal risk to subjects is reviewed by the full IRB at a regular monthly meeting.