"Behavioral interventions" means that clinical or medical procedures, such as blood draws, even if low risk, are not included in exemption 3.
A "benign" intervention may include ordinary, mild, transient forms of discomfort, such as the stress associated with completing a timed cognitive task, anxiety about performance, and boredom. In assessing whether the research might reasonably be offensive or embarrassing to subjects, the researcher should consider the characteristics of the subject population (e.g. are there particular cultural norms that may be active?) and the research context (e.g. how private is the setting?).
"Brief in duration" is intended to refer to the intervention as opposed to the intervention and the data collection activities together. Thus, the data collection activities could proceed over a longer period of time.
Data may only be collected using verbal or written responses or audiovisual recording, which excludes data collection by Fitbit, heart rate monitors, or any other devices placed on the subjects' bodies.
A subject's "prospective agreement" must be meaningful, but it is not the same as a requirement for explicit informed consent. For example, individuals who are simply made aware that research data will be collected as they voluntarily complete a computer task may be understood as having agreed to participate.
(These notes are based on the SACHRP Committee 2017 "Recommendations on Benign Behavioral Interventions.")
Like Exemption 2(iii) above, limited IRB review for Exemption 3(i)(C) must determine that the privacy of subjects and confidentiality of data are adequately protected. U-M also requires for Exemption 3(i)(C) that any informed consent document(s) and/or recruitment materials are submitted with the application. Please use the Exempt consent template available through the IRBMED Specialty Informed Consent Templates webpage; the Standard consent template is not appropriate.
- U-MIC presentations
- HRPP Exemption Changes webpage
- Exemption 3 Tip Sheet ("References and Resources" heading)
- Limited IRB review ("Exemption review paths" heading)
2018 Exemption 3 resembles a retired U-M Flexibility Initiative "Exemption 2A."
Pre-2018 Federal Exemption 3 was rarely, if ever, used at U-M.