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Category 3 - Benign Behavioral Interventions

The Regulatory Citation and How It Applies:

“Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

A.  The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; 
B.  Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
C. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review.” [§46.104(d)(3)]

Limited Review

Limited IRB requires the IRB to determine that there are adequate provisions for protecting privacy and confidentiality.  Limited Review is carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB.  
The activities allowed under this exemption do not require limited review if:
  • The information is recorded anonymously (Part A).
  • The information is recorded with identifiers but the research would not place the participant at risk (Part B).
Research under Exemption Category 3 involving identifiable (Part C), sensitive information can be conducted with a Limited Review.
 

Definitions

Anonymous (Part A)
No one – other participants, researchers, PI, etc. - can know if someone even participated in the research.
  • No identifiers can be connected to the data, either directly or through a coding system.
  • Video/audio recordings and photographs are not considered anonymous.
  • Multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would be identifiable and would not be considered anonymous.
Identifiable (Parts B and C) allows for data to be collected with identifying information (e.g., the researcher has a key linking respondents' names to coded identifiers).
Risk of Disclosure (Part B) means that the research can be exempt only when there are no significant detrimental consequences to the participant if identifiable information were disclosed outside of the research. Whether consequences would be significant and detrimental depends in part on context. For example, including a question about sexual identity in an interview study that investigates adults’ plans to change careers could be non-controversial (and exempt) in some locales but highly sensitive (and therefore non-exempt) in other places.
Category 3 exemption only allows for certain types of data collection methods.  The only data collection methods allowed under this exemption category are verbal or written responses (e.g., surveys or interviews, test responses, data entry), observation, or audiovisual recordings.  Data cannot be collected via physical procedures such as blood pressure monitoring, EEG, activity trackers (e.g., Fitbit), eye trackers, or blood draws. 
 
A behavioral intervention involves the performance of a cognitive, intellectual, educational, or behavioral task or the manipulation of the participant’s physical, sensory, social, or emotional environment. Because medical interventions are not behavioral interventions, studies that include medical tests, medical procedures, and/or the use of medical devices are not eligible for exemption under category 3. 
Benign behavioral interventions are 
  • brief in duration
  • harmless
  • painless
  • not physically invasive
  • not likely to have a significant adverse lasting impact on the participant
  • the investigator has no reason to think the participants will find the interventions offensive or embarrassing.

Brief in duration means no more than a few hours in a single day.

SPECIAL INFORMATION

EXCEPTION: This exemption does not apply to research with children.  Research involving prisoners as direct participants (prisoners are sought as participants) is not allowed; prisoners may be allowed in this research only if they are included as incidental participants.
 
HIPAA:  Because this exemption will allow surveys, interviews, and focus groups with a patient population, HIPAA regulations could apply.  HIPAA does NOT allow for the waiver of documentation of HIPAA authorization; therefore, research conducted in person (e.g., interviews and focus groups) will require written HIPAA authorization from the participants.  For those studies that are conducted remotely (e.g., online survey), you must complete a Waiver of HIPAA Authorization to explain why you cannot obtain written HIPAA authorization.
DECEPTION:  This exemption does not permit the use of deception unless participants are told prior to their participation that they will be unaware of or misled about the nature or purposes of the research and they agree to participate. Debriefing is encouraged.

EXAMPLES

Examples of Research Exempt Under Category 3 NOT Requiring Limited Review:
Part A (anonymous):
  • A study asking nurses to watch a one-minute video on handwashing and then mail in an anonymous survey about their handwashing practices over the following week.
  • Research involving the placement of a diabetes education pamphlet in a clinic and asking patients in the waiting room to complete a pre-/post test after reviewing the pamphlet to determine increase in diabetes knowledge.  Participants placed completed pre/post surveys in an envelope in a locked, slotted box in the waiting room when done. No identifiable data was collected.
Part B (identifiable, no risk from disclosure):
  • A study asking graduate students to browse a popular social networking site and then time their efforts to solve a complex word puzzle.
  • Randomly assigning diners to be provided either a suggested tip or no suggested tip after their meal, and are then provided a survey regarding their experiences.  Participants are told about the study and informed that certain aspects of the study will be revealed to them only at the conclusion of the survey. 
  • Healthy adult participants are asked to take part in two 1-hour-long assessments of memory, attention and information processing speed before and after 1 hour of cognitive enhancement exercise using specially designed computer software. The procedures are conducted during a single visit, and subjects are encouraged to take breaks when desired.
  • A study involving interviews with college seniors (age 18 and older) about their career plans after reviewing a documentary on job growth in various sectors. The researcher will record their date of birth and give the participant an algorithm to create a unique code (e.g., the last 4 digits of your cell phone number plus the first four letters of your mother’s maiden name).
Part C (limited review required):
  • A group of expectant mothers are asked to screen educational material regarding post-partum depression and are interviewed regarding their understanding of post-partum depression.
  • Participants are given a diabetes education pamphlet and asked to perform video-recorded testing based on their recollection of the information provided.
Examples of Research NOT Exempt Under Category 3:
  • A study involving the videotaping of pedestrians’ behavior when the timing of a public Walk/Don’t Walk is manipulated.  This involves a benign behavioral intervention; however, participants could not prospectively agree.  
  • A study involving a month-long music intervention at a retirement home with a pre-test and then a follow up survey a month after the intervention ended.  The study is a benign behavioral intervention but is not brief in duration.
  • Recordings of blood pressure and pulse are obtained along with the collection of a saliva specimen for the measure of cortisol level from adult subjects in a study linking physiological arousal to cognitive performance on a standard series of computer games.  The procedures last 75 minutes. The data collection methods described in this research are not allowable under Exemption Category 3.
  • College students take part in a study involving computer simulation of an online dating app in which each student is ultimately rejected by a prospective date who is in fact a member of the study team.  The students are asked to agree to the research and are told that aspects of the research goals and methods are being withheld from them until after their participation. This study could involve embarrassment for the participant and is, therefore, disallowed under Exemption 3.

FAQs Regarding Category 3 Exemption

Category 3 – What if I’m not sure if it’s an intervention?
Contact the OIRB (934-3789) to speak to an OIRB representative who can help you decide.