Surveys, interviews, questionnaires, and observational research are common methods for collecting information in social and behavioral research.
Because these activities may appear straightforward or involve minimal risk, researchers sometimes assume that they automatically qualify for exempt research.
However, that is not always the case.
Certain research involving educational tests, survey procedures, interview procedures, and the observation of public behavior may qualify under Exempt Category 2, but the study must meet the applicable regulatory criteria.
Understanding how Category 2 works can help researchers better prepare their IRB submissions and avoid assuming that a survey or interview study is automatically exempt.
What Is Exempt Category 2?
Exempt Category 2 covers certain research involving:
- Educational tests
- Survey procedures
- Interview procedures
- Observation of public behavior
The category may apply when the research meets one of the criteria established under the federal regulations.
The type of information being collected and the potential consequences of disclosure are important considerations when determining whether a study qualifies.
Educational Tests
Category 2 may apply to research involving educational tests.
Educational tests can include activities designed to measure knowledge, aptitude, achievement, intellectual ability, or similar educational characteristics.
However, researchers should clearly describe how the test will be used and what information will be collected.
The IRB may need to consider whether participants can be identified directly or indirectly and whether disclosure of their responses could reasonably place them at risk.
Survey Procedures
Survey research is one of the most common types of research considered under Category 2.
A survey may ask participants about a wide range of topics, including:
- Experiences
- Opinions
- Behaviors
- Attitudes
- Demographic information
- Professional experiences
- Educational experiences
But not every survey automatically qualifies as exempt.
One important consideration is whether the information collected could identify participants.
Another consideration is whether disclosure of participants’ responses could reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, educational advancement, or reputation.
For example, a survey that collects opinions about a general topic without identifying participants may present different considerations than a survey collecting identifiable information about illegal behavior, workplace concerns, or highly sensitive personal experiences.
The content of the survey and the way information is collected and stored are both important.
Interview Procedures
Interview research may also fall under Category 2.
Interviews can range from brief structured questionnaires to in-depth conversations about personal or professional experiences.
Researchers should clearly describe:
- Who will be interviewed
- What topics will be discussed
- Whether interviews will be recorded
- Whether participants will be identifiable
- How recordings and transcripts will be stored
- Who will have access to the information
As with surveys, the sensitivity of the information and the potential consequences of disclosure may affect whether the study qualifies for an exemption.
An interview involving identifiable information is not automatically ineligible for Category 2. However, additional requirements may apply, including limited IRB review in certain circumstances.
Observation of Public Behavior
Category 2 can also apply to certain research involving the observation of public behavior.
Researchers should carefully consider whether the activity being observed is truly public and whether participants have a reasonable expectation of privacy.
The specific research procedures are also important.
For research involving children, the regulations place additional limitations on the use of Category 2.
While certain research involving educational tests or observation of public behavior may qualify, the exemption does not apply to survey or interview procedures involving children. There are also limitations related to an investigator participating in the activities being observed.
Because of these additional protections, researchers should clearly describe the participant population and the observational procedures when children are involved.
Identifiable and Sensitive Information
Category 2 does not necessarily require all information to be anonymous. However, the presence of identifiable information can affect how the exemption criteria are applied.
Researchers should consider:
- Will names or contact information be collected?
- Can participants be identified through combinations of demographic information?
- Will responses be linked to identifiable individuals?
- Could disclosure of responses create risks for participants?
- How will the information be stored and protected?
A study involving identifiable and potentially sensitive information may still qualify for Category 2 under the applicable provisions, but limited IRB review may be required to evaluate privacy and confidentiality protections.
What Is Limited IRB Review Under Category 2?
Certain Category 2 studies involving identifiable information may require limited IRB review.
During limited IRB review, the IRB evaluates whether there are adequate provisions to protect participant privacy and maintain the confidentiality of research data.
This is especially important when the disclosure of participant responses could create risks.
Researchers should provide a clear description of:
- How identifiable information will be collected
- Where data will be stored
- Who will have access
- Whether information will be encrypted or otherwise secured
- How long information will be retained
- Whether identifiers will eventually be removed
Providing this information during the initial submission can help the IRB evaluate the proposed protections.
Can Survey Research Involving Children Be Exempt?
This is an area where researchers should be particularly careful.
The Category 2 exemption for survey procedures and interview procedures does not apply to research involving children.
Certain research involving educational tests may qualify, and certain observations of public behavior may qualify when the applicable requirements are met.
For observational research involving children, the investigator generally cannot participate in the activities being observed for the Category 2 exemption to apply.
Researchers conducting survey or interview research with children should not assume that Category 2 applies simply because the study involves minimal risk.
Common Misunderstandings About Category 2
“My study is just a survey, so it is automatically exempt.”
Not necessarily.
The subject matter, participant population, identifiability of the information, and potential risks associated with disclosure can all affect the determination.
“Anonymous surveys are always exempt.”
Not always.
Although anonymous data collection may support an exemption determination in some circumstances, the study must still meet the requirements of the applicable exemption category.
“If I collect names, my study cannot be exempt.”
Not necessarily.
Some research involving identifiable information may still qualify under Category 2, although limited IRB review may be required when the applicable criteria are met.
“All minimal-risk interview studies are exempt.”
Not necessarily.
Minimal risk alone does not determine whether a study qualifies for an exemption. The study must fit within a specific exemption category and meet the applicable criteria.
Preparing Your Category 2 Submission
When submitting survey, interview, or observational research, provide the IRB with a complete picture of what participants will experience.
Your submission should generally include:
- The purpose of the research
- A description of the participant population
- Recruitment materials
- All surveys or questionnaires
- Interview guides or discussion questions
- Observation procedures
- Consent or information sheets, when applicable
- A description of the information being collected
- Whether participants can be identified
- A description of privacy and confidentiality protections
- Data storage and security procedures
The IRB cannot fully evaluate the research based on a general statement that participants will complete a survey or participate in an interview. The actual questions and procedures are important.
Understanding Exempt Category 2
Category 2 provides an exemption pathway for many common forms of social and behavioral research, including certain survey research, interviews, educational testing, and observation of public behavior.
However, qualification depends on the specific details of the study.
Researchers should carefully consider the information being collected, whether participants can be identified, the sensitivity of the research topic, the potential consequences of disclosure, and whether children will be involved.
For a broader overview of all eight exemption categories, visit our guide to Understanding Exempt Research.
You can also explore our resources on survey research and IRB review to learn more about preparing surveys and questionnaires for submission.
Disclaimer: This article provides general educational information and is not a substitute for an IRB’s review or determination regarding a specific research study.