Worksheet for Consideration of Exempt Research
Does the study meet the following criteria?
YES
NO
Research conducted in established or commonly accepted educational settings, involving normal educational practices such as: research on regular or special educational instructional strategies, or the relative effectiveness of instructional techniques, curricula, or classroom management techniques. 45CFR46.104(d)(1)
YES
NO
Research involving the collection or study of existing data, documents, and records. Existing data means that all the data, documents or records are in existence prior to IRB review. And, these sources are publicly available or the information is recorded by the investigator in such a manner that subjects cannot be identified either directly or through identifiers linked to the subjects.
YES
NO
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. The information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects, nor, if identified, place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation. 45CFR46.104(d)(3i)(A-C)
If you answered yes to at least one item above, the protocol will potentially qualify for exempt approval.
The IRB makes the final determination of exempt status during review of applications.
However, does this study involve:
|
YES
|
NO
|
Interactions, surveys, or interviews involving minors?
|
|
YES
|
NO
|
Pregnant women, prisoners, children or other vulnerable populations?
|
|
YES
|
NO
|
Any procedures that may cause a subject either physical or psychological discomfort or are perceived as harassment above and beyond what the person would experience in daily life?
|
|
YES
|
NO
|
Deception?
|
If you answer yes to any of these four items, the protocol
may not qualify for exempt approval.
45CFR46.104(b2)
Please answer the following questions to the best of your ability:
|
YES
|
NO
|
Is the probability of the harm or discomfort anticipated in the proposed research greater than that encountered ordinarily in daily life or during the performance of routine physical or psychological examinations or tests?
|
|
YES
|
NO
|
Is the magnitude of the harm or discomfort anticipated in the proposed research greater than that encountered ordinarily in daily life or during the performance of routine physical or psychological examinations or tests?
|
If you answer yes to either question above, the study
will not qualify for exempt approval.
45CFR46.104(d)(3i)