Research methods utilizing interactions to obtain study information may consist of surveys, questionnaires, interviews, focus groups, and tests (that do not include a prompt or measured response to an intervention).
Harms that occur from interaction-based methods typically occur from a breach of confidentiality, rather than study procedures themselves.
Clearly discuss the sensitivity of the information being obtained
The identifiability (both to the researcher and to others outside of the research context) of individuals to their responses and to participation in the research study
An evaluation of risk given the level of sensitivity and identifiability: is it minimal?
Whether there is potential to include secondary participants as subjects (private information obtained about someone without their consent)
Researchers often request assistance in determining whether their interaction-based research is eligible for exemption or if it will be reviewed under expedited procedures or by the full board. Protocols may be eligible under multiple categories; the most protective standard will be applied.
Education Research (exempt cat. 1)
Factors that may preclude exemption: greater than minimal risk (would not constitute normal practice); radically new instructional strategies or randomization of subjects (these methods deviate from normal educational practices).
Surveys, Interviews, Focus Groups (exempt cat. 2)
Identifiable means directly or through links to the subject.
Disclosure of individual responses to sensitive material would reasonably place participants at harm.
Audio or visual recordings <LINK to Recordings>
Educational Tests (exempt cat. 2)
Observations of Public Behavior (exempt cat. 2)
De-identified Data (exempt cat. 4)
DHHS sponsored (funded) or approved projects (exempt cat. 5)
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Recordings made for research purposes (voice, video, digital, or image) (expedited cat. 6)
Research on individual or group characteristics or behavior (expedited cat. 7)
Interactions that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.