The purpose of this information is to provide guidance for Exemption Category 3 of human subjects research regulations (45 CFR 46) and provide examples of “benign behavioral interventions” at The University of Texas at Dallas (UTD).
Exemption Category 3
(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 the determination required by §46.111(a)(7).
(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.
To qualify for the Category 3 Exemption, studies must include the following:
- Adult participants. All participants must be adults with the ability to prospectively consent to study procedures.
- Behavioral Intervention. Interventions are limited to:
- Communication or interpersonal contact with the participant;
- Performance of a cognitive, intellectual, educational or behavioral task; or
- Manipulation of the subject’s physical, sensory, social, or emotional environment.
A behavioral intervention does not involve physical tasks or physical manipulations (do not involve introduction or administration of instruments, substances, or energy onto or into the body) and are not harmful, painful, or distressing to participants.
- Data Collection Activities. Collection of data must be limited to
- verbal or written responses by the subject;
- data entry by the subject; or
- observation of the subject.
- Data Collection Limits. Collection of data can not involve:
- Application of sensors to the body (e.g., Fitbit, blood pressure monitor, EEG); or
- Collection of biospecimens.
- Benign Intervention. To be considered “benign” an intervention is not expected to cause physical or emotional harm, persistent discomfort or be embarrassing or offensive to the participant.
- Brief intervention. Interventions should be brief in duration. For an intervention to be considered ‘brief’, it should occur on a single day and should last a few minutes to a few hours.
- Prospective Agreement. Participants must provide prospective consent to the experimental procedures. If deception is involved, the participant must be notified that they will be unaware of or misled regarding the nature or purpose of the research. In such cases, investigators are encouraged to debrief participants after experimental procedures have ended.
- Privacy Protections. At least one of the following must be met:
- No information collected can identify a participant (directly or indirectly);
- 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
- 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.
|Exemption Category||Study Example||Exempt? Y / N||Explanation|
|#3||Participants view facial photos of individuals and answer questions about the emotions expressed in each photo. Experimental procedures are clearly described by investigators and subjects prospectively agree to participate. No identifying information is collected.||Yes||Experimental procedures are benign as they are unlikely to cause harm or discomfort to participants. No identifying information is collected from participants.Participants provide prospective agreement.|
|#3||Participants play an online decision-making game paired with virtual partners. Investigators tell participants that there are certain aspects of the study they will not be made aware of until after the intervention is complete. Participants are not told that their ‘partners’ are members of the research team and are misled about the purpose of the study.||Yes||Experimental procedures are unlikely to cause harm, discomfort, or embarrassment.Participants provide prospective agreement to the study with the knowledge that deception is used. No sensitive data is collected.|
|#3||Participants complete an anonymous survey about healthcare and are asked questions about their medical history. The purpose of the study and the intervention is clearly described and subjects prospectively agree to participate.||Yes||Medical history can include sensitive information; however, this is collected anonymously. Subjects provide prospective agreement to participate. Study is not likely to cause significant adverse impact.|
|#3||Participants will be asked to watch a series of 3 videos. Subjects have their blood pressure and pulse recorded after each video and will answer a brief demographic survey. Overall duration of the experimental procedures is 30 minutes.||No||The intervention is brief but the study involves collection of blood pressure and pulse. Exemption category 3 does not allow medical interventions, even if they are minimal risk. Study data would involve more than oral or written responses.|
|#3||Investigators videotape pedestrian behavior when a “Walk/Don’t Walk” sign is manipulated for research purposes.||No||Exemption 3 does not apply to studies where subjects are not aware they are participating in research (prospective agreement is required).|
|#3||First grade students are asked complete an activity related to reading assessment.||No||Exemption 3 is limited to research with adults.|
|#3||Participants are asked to complete daily journal entries for 1 month to record diet and sleep habits. They are asked to wear a Fitbit to record heart rate and exercise data.||No||Activities are spread out over the course of a month and are not brief in duration. Study data would involve more than oral or written responses because a Fitbit is being used.|