Exempt Criteria 45 CFR 46.104(d)(3)
(i)Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met*:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make a determination of exemption **
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
*Clarification: The University of Pittsburgh IRB requires review for exempt determination of all human subjects research meeting any of the 3 criteria above.
**This determination is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.
Additional Requirements and Considerations
- This exemption applies only to adult subjects.
- Adults with decisional impairment cannot be purposefully included
- Studies with interventions involving children do not meet the exempt criteria.
- Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.
- Behavioral interventions must be brief in duration (a few minutes or hours). Although there is no specific amount of time that is defined as brief, OHRP guidance suggests the intervention must be brief in nature, even if subsequent data collection takes longer.
- Interventions may not be harmful, painful or distressing. Risk to subjects is low.
- Interventions must be unlikely to have significant emotional discomfort or adverse lasting impact
- Study content and procedures must not be offensive or embarrassing to subjects
- Medical interventions and procedures are not permissible in this exemption
- Physical (bodily) tasks and physical exercise should not be included in this exempt category.
- Deception can only be used if the subject prospectively agrees to the use of deception. Subjects must be informed prior to initiating the intervention that they will be unaware of, or misled regarding the true nature or purpose of the research. They will also be told whether further information will be provided at the conclusion of the research activities. Researchers should consider de-briefing subjects.
- Research procedures in this exempt category should generally be limited to:
- communication or interpersonal contact with the subject,
- the performance of a cognitive, intellectual, educational or behavioral task, or
- manipulation of the subject’s physical, sensory, social, or emotional environment
- Data collection in this exempt category is limited to:
- verbal (oral) or written responses by the subject
- data entry by the subject
- observation of the subject
- audiovisual recording
- This category does not include the use of activites monitors, i.e FitBit, actiwatch, pedometer, activity tracking apps, etc.
Privacy and Confidentiality:
- Anonymous means that no one can identify the subject at any time.
- Recorded Anonymously means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
- Coded means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
- Data should typically be recorded anonymously or at least coded.
- When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.
- Sensitive information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.
- Certain research that does not meet the requirements for this exemption may be eligible for expedited review.
- Additional guidance has been provided by the Office for Human Research Protections Revised Common Rule video series