The Regulatory Citation and How It Applies:

“Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:(i) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subject,

(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subject, 
(ii) 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.
(iii) 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 §46.111(a)(7).” [§46.104(d)(2)]

Category 2 exemption criteria allow for both anonymously collected data (i) and data collected with identifiers (ii and iii).  This difference is the difference between data being collected anonymously vs. confidentially.

Limited Review

Limited IRB requires the IRB to determine that there are adequate provisions for protecting privacy and confidentiality.  Limited Review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.  

The activities allowed under this exemption do not require limited review if:

• The information is recorded anonymously (Part i).
• The information is recorded with identifiers but the research would not place the participant at risk (Part ii).

Research under exemption 2 involving identifiable, sensitive information must be conducted with a Limited Review.

Anonymous (Part i)

No one – other participants, researchers, PI, etc. - can know if someone even participated in the research.

• No identifiers can be connected to the data, either directly or through a coding system.
• Online surveys cannot collect URLs, IP addresses, email addresses
• In-person surveys cannot be returned in a manner where researchers can see who participated (e.g., handing a survey back to the investigator is NOT anonymous, but having all participants put the survey in an envelope at the front of the room is).
• Video/audio recordings and photographs are not considered anonymous.
• Interviews/focus groups are inherently not 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.

Identifiable (Parts ii and iii) allows for data to be collected with identifying information (e.g., the researcher has a key linking respondents' names to coded identifiers, the survey hosting site collects URLs or IP addresses that are available to the researcher).

Risk of Disclosure (Part ii) means that the research can be exempt only when there are no significant detrimental consequences to the participant if identifiable information were disclosed outside of the research. Whether consequences would be significant and detrimental depends in part on context. For example, including a question about sexual identity in an interview study that investigates adults’ plans to change careers could be non-controversial (and exempt) in some locales but highly sensitive (and therefore non-exempt) in other places.

Sensitive topics include, but are not limited to, questions about sexual activity, drug use, political/ religious affiliations or opinions, medical diagnosis, illegal activity, or other questions whose answers could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.  Sensitive topics may be included in Exempt Category 2 research 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 under Exempt review, but questions regarding sexual abuse will require Expedited or Convened review.  In the latter, a participant’s mere exposure to the question may elicit stress recounting emotional or disturbing events in their lives.  In this case, your project will need a higher level of review.

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 is not exempt.

The addition of the term “only” specifically disallows the implementation of interventions under this exemption.  Many studies involving interviews, surveys, or focus groups ask subjects to engage in some type of intervention or activity in connection with the questions or discussion.  Typically, the intervention occurs prior to the testing or between pre/post-tests.  The purpose of an intervention is to determine how an activity changes the participant or their performance. Many activities considered to be "tasks" do not meet this definition of "intervention."  In general, asking subjects to physically manipulate an object, play a game, complete a specific physical action, read, write, look at visual stimuli, listen to auditory stimuli, or imagine something would be considered interventions only if the intent of the activities were to change subjects or to compare results across different activities, physical stimuli, visual stimuli, auditory stimuli, etc.

The following activities are considered interventions: