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).
- 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 interaction-based methods typically occur from a breach of confidentiality, rather than study procedures themselves.
Researchers are advised to address the following criteria for approving their materials
Clearly discuss the sensitivity of the information being obtained
- ANY information collected about an individual's health (including mental health), academic standing (grades, discipline), sexual preferences, and illicit behaviors (drug use, crimes, substance abuse, violent behavior) is considered sensitive, but may also include other topics specific to the target population
- The collection of some personal identification numbers is considered sensitive (e.g. social security numbers, medical record numbers)
- More on Identifiable vs. De-identified Data
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
- Includes an evaluation of whether a private or public space is appropriate to carry out the research
- Consideration of contact methods including mailers, phone calls, social media/networking
An evaluation of risk given the level of sensitivity and identifiability: is it minimal?
- Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests
- An adequate data security plan may be required in order manage the risk of a study to minimal
- More about Minimizing Risk
Whether there is potential to include secondary participants as subjects (private information obtained about someone without their consent)
Reviewers will also be interested in assessing
- Whether the PI is qualified to conduct the methods described
- Validation of instruments, including for the target population, unless piloting new tools (quantitative)
- Adequate description of research purpose and goals (qualitative)
- Appropriate physical space or resources utilized
Level of Review Distinctions
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.
Exemption Criteria for Interaction-based Research
Education Research (exempt cat. 1)
- Must be conducted in an educational setting
- Must involve normal educational practices (determined by local context)
- Okay for minors
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)
- Participants must be adults
- Material is non-sensitive (may be identifiable)
- Material is sensitive but not identifiable
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)
- Must not include a prompt or intervention to which the participant is responding
- Okay for minors
Observations of Public Behavior (exempt cat. 2)
- Okay for minors if researcher does not participate in activities being observed
De-identified Data (exempt cat. 4)
- Must not have identifiers or links recorded
DHHS sponsored (funded) or approved projects (exempt cat. 5)
- To study, evaluate or examine public benefit or service programs
- Must not involve significant physical invasions or intrusions upon the privacy of participants
- Okay for minors
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 Interaction-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)
Interactions that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.