Exempt Categories 2 and 3 Examples

Below are some examples of research that are exempt from IRB review under category 2.

• Research consists of an online survey of sexual behaviors; responses cannot be linked to respondents at any time, directly or indirectly. This is exempt because data are collected anonymously.
• Researchers conduct a focus group about consumer products – participants’ names, addresses and phone numbers are collected. This is exempt because data are not sensitive.
• Researchers conduct a survey about illegal activities – a code is used to link survey data back to individual respondents. This is exempt, but limited IRB review is required, because data are sensitive (risk of criminal liability) and identifiable.
• Research consists of behavioral observation at a public park. This is exempt because the behavior occurs where no special permission is required to observe.

Below are some examples of research that are not exempt from IRB review under category 2.

• Research consists of observation of attorneys and clients at a law practice. This is not exempt because the behavior occurs where there is a reasonable expectation of privacy.
• Research consists of a focus group conducted with children. This is not exempt under category 2 because research with minors is limited to educational tests or observation without interaction.
• Participants complete a questionnaire before and after a counseling intervention. This is not exempt because the study involves an intervention that is distinct from the data collection method.
• A study involves saliva collection and blood draw. This is not exempt because the collection of biospecimens is not permitted under exempt category 2.
• Investigators conduct a survey that links responses to respondents’ financial information. Linking data with other personally identifiable information is not permitted under exempt category 2.
• A longitudinal survey with previously recruited participants that will link current survey responses to survey responses provided ten years ago. Linking current data with data provided in the past is not permitted under exempt category 2.

Below are some examples of research that are exempt from IRB review under category 3.

• Subjects who play video games regularly, play a violent video game and complete a written test. The investigator describes the study procedures and intervention and subjects prospectively agree to participate. This research is exempt because there is benign behavioral intervention (subjects are unlikely to be offended), collection of non-sensitive information through written responses and prospective agreement.
• Subjects prospectively agree to memorize and recall a list of words while being distracted – responses are audio-recorded. Subjects are told they will be unaware or misled regarding the nature or purpose of the study. The investigator conceals details of the distraction. While limited IRB review is required, this research is exempt because there is benign behavioral intervention (subjects are unlikely to be embarrassed), prospective agreement, collection of non-sensitive information via audio recording and concealment with notice.
• Subjects are given educational materials with the intention of changing their behavior (e.g., smoking cessation), and then report sensitive health history via an anonymous survey. The investigator describes the study procedures and intervention and subjects prospectively agree to participate. This research is exempt because there is benign behavioral intervention (not likely to pose a significant lasting adverse impact), prospective agreement and sensitive data is collected anonymously via survey.
• Teams of adult volunteers prospectively agree to engage in brief cooperative activities and then verbally report their progress. This research is exempt because there is brief benign behavioral intervention, prospective agreement and non-sensitive data is collected anonymously via verbal responses.
• Subjects prospectively agree to play an economic game and complete a written survey about negative attitudes toward their employer. The survey includes dates and employment history that could be used to re-identify respondents. While limited IRB review is required, this research is exempt because there is benign harmless behavioral intervention, prospective agreement and sensitive identifiable information via written responses.

Below are some examples of research that are not exempt from IRB review under category 3.

• Subjects prospectively agree to give an impromptu speech and complete a math task aloud while being rushed. Deception is involved in the form of frowning judges. Subjects are not told they will be unaware or misled regarding the nature or purpose of the study. This is not exempt because the behavioral intervention is not benign because the subjects could be embarrassed – without debriefing, the intervention could pose a significant lasting adverse impact. The use of deception without notice is also not allowed.
• Investigators videotape pedestrian behavior when a “Walk/Don’t Walk” sign is manipulated for research purposes. This is not exempt because exempt category 3 does not apply to studies where subjects are not aware that they are participating in research.
• Benign behavioral intervention is followed by verbal responses from children. This is not exempt because category 3 is limited to research with adults.
• Subjects undergo electroencephalogram (EEG) while presented with visual stimuli on a computer screen. The study collects data via activity trackers (e.g., Fitbit) and eye trackers. This is not exempt because data may not be collected via physical procedures.
• Researchers conduct an online survey with embedded intervention (health scenarios) links responses to respondents’ criminal records. This is not exempt because linking data with other personally-identifiable information is not permitted under exempt category 3.