Benign Behavioral Interventions

What are Benign Behavioral Interventions?

A Benign Behavioral Intervention (BBI) is a new category of IRB review in which the research interactions with adult participants are deemed “harmless.” BBIs are designated as exempt studies, meaning that they only undergo initial review and do not need to be annually re-approved. View a sample BBI Cayuse submission.

In order to be classified as a BBI, a research study must fulfill the following criteria:

Participants

• participants are exclusively adults who have adequate decision-making capacity to agree to participate
  • participants can include members of vulnerable populations if:
    • their vulnerability does not impact their ability to consent
    • the research could not be considered inherently offensive or harmful to the population at hand
    • the members of a vulnerable population are only included incidentally, not exclusively

Research

• research is brief in duration – should be a maximum of a few hours on a single day
• participation is harmless and painless
  
• the intervention does not introduce risks of harm, physical or emotional discomfort, offense or embarrassment
• can only include the following procedures:
  • communication or interpersonal contact with participants
  • performance of a cognitive, intellectual, educational or behavioral task
  • manipulation of participants’ physical, sensory, social or emotional environment (e.g., manipulating a keyboard, doing a puzzle or walking while listening to music)
• BBI cannot include:
  • interventions that are physically invasive or could be harmful or painful
  • introduction or administration of instruments, substances or energy onto or into the body
• can only include deception if participants agree to participate following disclosure of the fact that they will be unaware of or misled regarding the nature or purpose of the research

Data Collection

• data collection is limited to only be
  • verbal or written responses (including data entry)
  • observation of the participant, including audio and/or visual recording
• requires prospective agreement forms to participate (i.e., researchers would need to submit a prospective agreement script, and study must be appropriate for prospective agreement as opposed to explicit consent via a signed consent form)

Privacy Protections

• at least one of the following privacy protections must be met:
  • the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, either directly or through identifiers linked to the participants
  • the information obtained is recorded by the investigator in such a manner that the identity of the participants can be readily ascertained, either directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §__.111(a)(7).
  • any disclosure of the participants’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, educational advancement or reputation