Research methods utilizing observations to analyze unprompted behavior in a public or private setting. Examples may include ethnography, participant observation and internet research.
Harms that occur from observation-based methods are typically those resulting from the identifiability of the participant within the research context or to individual behaviors recorded; however, harms may persist long after observation is concluded once a participant reads accounts of their behavior as noted by the researcher, despite having provided consent or de-identified measures taken.
Deception Research <link>
Observation-based research is narrowly eligible for exemption and is otherwise reviewed under expedited procedures or by the full board. Protocols involving mixed methods may be eligible under multiple categories; the most protective standard will be applied.
More on Levels of Review
Observations of public behavior (exempt cat. 2)
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)
Observations that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.