There is a large variety of instruments and tests, from simple puzzles given to children to complex picture tests given to adults using computers. The primary consideration for these tests is first, the risk they present to the participant, and second, whether the data collected from the participant poses any risk to the participant. On one end, if a participant is able to access the test anonymously online and/or the content of the test is benign, the test functions similarly to an anonymous survey and should qualify for exemption. As anonymity decreases and risk increases, so does the requirement for consent. The Board will want to know:
- Where and how will the intervention be presented?
- Who will present the intervention? Is the intervention presented online or in person?
- What data are collected (including identifiers)?
- Is the intervention a singular event or part of a longitudinal event? Is the intervention connected to other data?
- How are the results stored and reported?
Exempt studies are not under the same obligation to obtain consent from participants (though the Board often asks researchers to provide information about the study to participants using a Study Notification). Educational Tests (cognitive, diagnostic, aptitude, achievement) can be exempted if one the following are true:
- the information is recorded by the investigator in such a manner that the identity of the participant cannot be readily ascertained directly or through identifiers linked to the subject, the investigator does not contact the subjects, and the investigator will not re-identify the subjects.
- any disclosure of the participant’s responses outside the research would not reasonably place the participant at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
- if the participant is identifiable, there are adequate measures to protect privacy and confidentiality.
In addition, prisoners taking educational tests cannot be exempted. If the educational test involves a minor, the investigator cannot participate in the educational testing and the minor’s identity cannot be recorded.
If the protocol qualifies for exemption, the Board does not require researchers to obtain consent from participants. If the protocol does not qualify for exemption, it doesn’t mean that the study can’t proceed. If consent is an obstacle for conducting the study, the Board may consider waiving consent but otherwise for instruments and educational tests that don’t meet the exemption qualifications, the Board will require that the researcher obtain consent from participants.
If the instrument is not considered an “educational test,” it may be considered a “benign behavioral intervention.” A benign behavioral intervention:
- is a collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording
- brief in duration
- harmless, painless, not physically invasive
- is not likely to have a significant adverse lasting impact on the subjects
- and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing
- does not involve deception unless the participant prospectively agrees to the possibility of being unaware or misled regarding the nature or purposes of the research
- does not include prisoners or minors.
Examples include having the subjects play an online game, solving puzzles under various noise conditions, or deciding how to allocate a nominal amount of received cash between themselves and someone else.
An exempt benign intervention must include a prospective agreement to participate and one of the following must be true:
- 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;
- 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
- 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.
If the protocol qualifies for exemption, the Board does not require researchers to obtain consent from participants. If the protocol does not qualify for exemption, it doesn’t mean that the study can’t proceed. If consent is an obstacle for conducting the study, the Board may consider waiving consent but otherwise for instruments and educational tests that don’t meet the exemption qualifications, the Board will require that the researcher obtain consent from participants.
- Describe an instrument or test by creating a Data Source in the Data Source section.
- Upload the instrument or test in the Data Source Upload.
- If you need permission to conduct the test, upload any files that document permission in the Permissions section.
- If you have more than one Data Source and the sources are linked, the Associate Data Sources with Data Sources is the section where you can demonstrate and describe this relationship.
- The Associate Data Sources with Participant Groups is the section where you can demonstrate the relationship between Participant Groups and Data Sources (if you have more than one of both).