The Regulatory Citation and How It Applies:
“Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subject,
(ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.” (§46.101(b)(2))
Category 2 exemption criteria allows for both anonymously collected data (i) and data collected with identifiers (ii).
Anonymous (Part i)
- Required if your survey or questionnaire involves questions of sensitive nature
- No identifiers can be connected to the data, either directly or through a coding system.
- Video/audio recordings and photographs are considered to be identifiable; therefore, any data collection that involves these activities would not be considered anonymous.
- Multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.
Identifable (Part ii)
- Allows for data to be collected with identifying information (e.g., the researcher has a key linking respondents' names to coded identifiers), but the information is so innocuous that, in the event of disclosure outside of the research, there would be no detrimental consequences to the subject.
Public behavior refers to behavior taking place in a publicly accessible location in which the subject does not have an expectation of privacy (e.g., a public plaza or park, a street, a building lobby, a government building). If subjects have a reasonable expectation of privacy (e.g., medical exam room, private office) at the location where the researcher is conducting the observation, the project may not be considered exempt.
EXCEPTION: This exemption is narrowed in scope by 45 CFR 46 Subpart D’s additional protections for research involving children. Where children will be involved as research subjects, the use of survey or interview procedures is eliminated from this exemption, and so is any research involving the investigators participating in the activity being observed. OHRP has also stated that observing a classroom does not constitute public behavior and is not permitted for this exempt category.
Anonymous survey or questionnaire content may contain some sensitive questions as long as exposure to the questions themselves does not cause harm. For example, an anonymous questionnaire about sexually transmitted disease history may be acceptable, but questions regarding sexual abuse will not. In the latter, mere exposure to the question may experience trauma recounting emotional or disturbing events in their lives; therefore, risks to the participant will need a higher level of review.
Examples of Research Exempt under Category 2:
- A study involving an anonymous survey regarding workplace satisfaction at area firms.
- An observational study of children playing in a public park; the researcher takes notes of what occurs, recording sex, race, and length of activity of children, but does not interact with subjects.
- A study involving interviews with college seniors (age 19 and older) about their plans after graduation. The researcher will record their date of birth and give the participant an algorithm to create a unique code (e.g., the last 4 digits of your cell phone number+the first four letters of your mother’s maiden name). This could be identifiable, but the answers to questions asked would present no risks to subjects if divulged outside the research.
- A study involving focus groups with expectant mothers regarding their perceptions of car seat designs.
- A study involving an anonymous survey of college seniors regarding recreational drug use.
Examples of Research NOT Exempt under Category 2:
- A study involving audio-recorded interviews where the researcher is examining how being diagnosed with fibromyalgia affects parenting. No names or other identifying information will be collected. The study is not considered anonymous because the interviews will be audio-recorded, and medical information is generally deemed sensitive information.
- An anonymous survey given to inmates of the local county jail. Research involving prisoners cannot receive exemption under any category.
- Research involving interviews with the underage children about their TV habits. Research involving the survey of minors does not qualify for Category 2 exemption.
- An observational study where a researcher pretends to fall and records helping behavior in children in a public park. Observational research involving children does not qualify for Category 2 exemption in cases where the researcher will interact with participants.