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 subjects 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 .111(a)(7).
*Benign behavioral interventions can be defined as 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.
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.
**Limited IRB Review requires that the IRB determines that the following criteria for IRB approval at .117(a)(7) is satisfied; When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.