Research methods utilizing observations to analyze unprompted behavior in a public or private setting. Examples may include ethnography, participant observation and internet research.
- The submission is first confirmed as covered research with living human subjects or their identifiable, private information.
- Then, eligibility for exemption is determined.
- If review takes place under expedited procedures or by the full board, these Criteria for Approval will need to be met in addition to any applicable state or local laws and University/HRRC policies.
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.
Researchers are advised to address the following in their materials
- A clear description about observations that will take place, along with:
- The nature of the behavior being evaluated
- How information will be recorded and analyzed
- What (if anything) will be shared about the study with those being observed, including debriefing (information offered after the observation(s) take place), and recruitment materials
- What expectations of privacy would the observed participant reasonably have?
- Will the researcher be in any way involved in the activities being observed?
- Does the observation occur in a commonly accepted PUBLIC space?
- If observing behavior occurring in a PRIVATE space, address how ethical access will be obtained to that private location and what will be communicated to participants or their guardian/legally authorized representative, about the observations taking place.
Deception Research <link>
Reviewers will also be interested in assessing
- Whether the PI is qualified to conduct the methods described
- Potential discomfort to those being observed (e.g. public restroom behaviors monitored from a public hallway, or upon reading research publications)
- Factors unique to internet research:
- How participation of minors will be addressed
- Reliability and validity of the data collected vs. any potential risk
- Whether there is a reasonable expectation of privacy by participants using a site under observation
- Screen shots of recruitment pages may be requested
Level of Review Distinctions
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
Exemption Criteria for Observation-based Research
Observations of public behavior (exempt cat. 2)
- Identifiers may be recorded but disclosure MUST NOT reasonably place the subject at risk of harm OR
- No identifiers recorded
- Okay for minors IF the researcher doesn't participate in the activities being observed
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Expedited Criteria for Observation-based Research
Recordings made for research purposes (voice, video, digital, or image) (expedited cat. 6)
- MUST be minimal risk (procedures may be managed to minimal risk)
Research on individual or group characteristics or behavior (expedited cat. 7)
- May include research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior
- MUST be minimal risk (may be managed to minimal risk)
Observations that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.