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 2.

Category 2 indicates that protocols may be exempt from IRB review if the research “only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording).” However, not all research that meets this description can be considered Exempt, as exemption may depend on the types of identifiers included with the data. Identifiers can be both direct identifiers (e.g., name, address, social security number, patient ID) or indirect identifiers (e.g., a code that links data back to the subject, a combination of non-direct identifiers that can be used to deduce a participant’s identity). The research must meet one of the following restrictions below: 

1. Recorded information cannot readily identify the subject (directly or indirect identifiers linked to the subjects); OR
2. 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; OR
3. The information is obtained 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.

“Interactions involving educational tests...survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording)” - Exempt Review, Category 2

Below are a few scenarios that may be exempt from review based on Category 2.

Example A: A researcher stands on a public street and asks adult pedestrians to participate in a five-minute interview about their thoughts on a public works project. He takes an audio-recording of the interview but does not record any identifying information about the participants. He plans to transcribe the interviews for analysis by computer-assisted qualitative data analysis software. Once transcriptions are complete, the researcher plans to destroy the audio recordings of the interviews, leaving only the transcription texts for analysis.

• Is it Exempt Category 2? Yes, the researcher’s data collection only involves interview procedures. Additionally, the audio recordings meet the criteria that “recorded information cannot readily identify the subject,” as the researcher does not plan to collect identifiers.

Example B: A student researcher plans to conduct individual interviews with professors and then administer surveys to the professors at different points during the year. During the interview, she will collect participants’ perceptions of the COVID-19 pandemic’s impact on their students’ ability to participate in class. These interviews will not be recorded, and no identifying information will be collected. The surveys will be administered at three different time points during the academic year. The participants will report on their stress levels and teaching strategies.

• Is it Exempt Category 2? As the researcher will not be recording or collecting identifying information during the individual interview process, the interviews would meet criteria for exempt Category 2. In order to conduct a follow-up survey with these same individuals, the researcher may have to create a coding system to link the surveys together. So long as the information collected in the surveys does not pose significant detrimental consequences to the study participants, the surveys may still be categorized as Exempt Category 2. These study activities are reviewed on a case-by-case basis by the IRB.
• Exceptions: Any collection of students’ grades or educational records may be protected by Family Education Rights and Privacy Act (FERPA), and thus does not fall under Exempt Category 2.

Example C: In a now infamous study known as the Tearoom Trade Study, a researcher collected data on anonymous male sexual behavior in public restrooms. He also interviewed some of the men who participated in these activities, including gathering their demographic information. He meticulously protected the identities of the participants, keeping their data confidential. At times, however, he did not disclose to the participants that he was a researcher. He also intentionally deceived participants when he went to their homes to conduct follow-up research, failing to gain informed consent. 

• Is it Exempt Category 2? This study is regarded as a textbook example of researcher ethical violations. Though the study confronted assumptions and stereotypes of the day (the 1960s), the sexual acts recorded were illegal; in many cases, disclosure of these acts would have been harmful to the subjects' social standing and put them at risk of criminal liability. The parameters of the study do not meet the requirement that the “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.” Additionally, the study included a number of ethically concerning elements, such as the deception, contested nature of public bathrooms as “public spaces,” and lack of informed consent.

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.

— Kailee Kodama Muscente, M.A.