Federal regulations stipulate that certain research activities may be considered exempt from regulatory requirements under the Common Rule (45 CFR 46), if approved by the IRB and confirmed in writing to the Principal Investigator (PI). These activities must fall into one of the eight predefined Exempt categories set forth by the Office of Human Research Protections (OHRP).
Researchers may believe that “exempt” review means that they do not need to submit a protocol to the IRB. However, studies that are categorized as “exempt” are only exempt from federal regulations stipulated in the Common Rule (45 CFR 46). In other words, this type of research is still subject to state, city, and institutional policies. At Teachers College (TC), all human subjects research must be submitted to the IRB for review.
Researchers new to the Institutional Review Board (IRB) may be unfamiliar with the different activities within each Exempt category. This post will provide examples of research that typically falls under Exempt Review - Category 3.
Category 3 indicates that protocols may be categorized as exempt if the research poses no more than minimal risk to participants and involves “benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal, written responses, including data entry or audiovisual recording if the adult subject prospectively agrees to the intervention and information collection.” The research must also meet one of the following restrictions below:
- Recorded information cannot readily identify the subject (direct or indirect identifiers linked to the subjects); OR
- Any disclosure of the human subjects’ responses outside of the research would NOT reasonably place subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.
But what exactly is a “benign behavioral intervention”? Federal regulations stipulate that “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.”
Additionally, “if the research involves deceiving the subjects regarding the nature or purpose 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 [they] will be unaware of or misled regarding the nature or purpose of the research.”
“Benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal, written responses, including data entry or audiovisual recording” - Exempt Review, Category 3
Below are a few scenarios that we will examine under the requirements of Category 3.
Example A: A researcher plans to measure participants’ physiological stress while they play a board game in which they compete against players to achieve a goal defined by the game. During the consenting process, participants are fully informed that the game may include elements of deception as part of the typical board game rules. Individuals are also informed of their role in deceiving other players, and the possibility that players may try to deceive them. The researcher plans to have the participants wear non-invasive sensors that measure heart rate and sweat. This data will be collected during a 10 minute baseline session and then throughout the game for a total of 20 minutes. No identifying information will be collected.
- Is it Exempt Category 3? Although this study includes some elements of Category 3, it ultimately does not meet the criteria. Researchers are required to
- Gain prospective consent
- Debrief participants about purpose of a study “if the research involves deceiving the subjects regarding the nature or purpose of the research”
While the gameplay involves deception, the researcher does intend to deceive participants as to the true nature of the study. Though the researcher is doing their due diligence to fully inform the participants of all elements included in the gameplay, the deception involved is not the kind described in Exempt Category 3. The study fails to meet criteria for Exempt Category 3 as it collects data using a device (the non-invasive sensor). Under Category 3, the data may be collected by means of “1) verbal (oral) or written responses by the subject, 2) data entry by the subject, or 3) observation of the subject” (OHRP).
Exceptions: If the researcher removed the sensor and instead, 1) had participants periodically check and report their pulse throughout the study and 2) observed participants’ emotional and physical states, the study may qualify as Exempt Category 3. Additionally, the board games activities must be deemed unlikely to cause significant offense or embarrassment to the participants in order to qualify for a Category 3 Exemption.
Example B: Adults competent to consent are asked to participate in a research study examining the influence of different types of instrumental music on their ability to focus while solving math problems. Participants are randomly assigned to listen to various types of music (e.g., classical, jazz, and soft rock) while solving math problems for 1 hour. After data collection ended, participants were rated on the speed and accuracy of their problem-solving. No identifying information was collected about the participants.
- Is it Exempt Category 3? Yes, the researcher’s data collection only involved adult subjects and a behavioral intervention that was “brief in duration, harmless, painless, and not physically invasive.” Although the subjects might feel embarrassed or distressed if they could not complete the math problems, this is not likely to have a “significant impact” on the subjects. Additionally, the study meets criteria that it be “brief” in duration; according to federal guidelines, this can be anywhere from “a few minutes to a few hours” (OHRP).
Example C: A researcher wants to study the eye-tracking movements of speed-readers. Adult participants must meet the inclusion criteria of reading 400 words per minute and pass a reading comprehension test. Participants who pass these assessments will place their head on a chin rest in front of a monitor and speed-read a series of passages. The participants’ eye movements across the passage will be recorded by a digital camera. Digital software will be applied to the eye recordings to track which words participants focused on when speed-reading. The total time for the study will take approximately 45 minutes.
- Is it Exempt Category 3? Yes, the intervention does not require the participants to undergo invasive procedures or wear sensors, which would disqualify the study from Exempt Category 3. Additionally, the participants will be providing their written responses to the reading comprehension tests, meeting the requirement that data be collected via “1) verbal (oral) or written responses by the subject.” The use of video recordings is in compliance with the limitation that information collection be through an “audiovisual recording.” Finally, the time for the study meets requirements that the intervention is “brief.”
For more examples of benign behavioral research, please review this guidance offered by the federal Office for Human Research Protections (OHRP). Research activities may fall into one or more Exempt categories depending on a variety of factors, including the study population, researcher expertise, coinciding events, etc. TC IRB administrators will always review research on a case-by-case basis.