Guide :: Education :: Exempt :: Normal Educational Practice
Normal Educational Practice
What is normal educational practice? According to CFR 45 part 46.101.b(1), “research conducted in established or commonly accepted educational settings, involving normal educational practices…” can be considered exempt. The regulations define normal educational practice as “(i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.” In order to qualify for exemption, a protocol must also demonstrate that participants will not be at greater than minimal risk when they participate. Protocols qualifying as normal educational practice are not exempt from following the ethical principals set forth in the Belmont Report such as respect for persons.
Research exempted as normal educational practice is often conducted in public-school settings which may demand that specific steps be followed in order to comply with additional state and federal laws. Although the definition in the regulations is fairly straightforward, it can create a conflict with other regulations that the IRB is obligated to follow as well, such as Subpart D of CFR 45 part 46, FERPA, and PPRA. For example, Subpart D of CFR 45 part 46 specifically deals with children as a vulnerable population and most protocols that qualify for normal educational practice deal with children. If the Board determines that a research project does not qualify for exemption as normal educational practice, then the extra protections for minors under Subpart D apply.
If a protocol does qualify as normal educational practice, the Board generally requests that parents are at least notified about the study via a letter home. For more information, please see Consents. One aspect that you should also consider is that if a student is in a classroom, he or she is generally obligated to participate in the classroom activity. In a normal educational practice study, the participant may be required to do classrooom activities and assignments, but they should not feel obligated to release data to you. Please consider how you will handle situations where a participant wants to withdraw from the study and make sure that parents and students are aware of what is required by the instructor and what is requested by the investigator.
Does my study qualify as normal educational practice? In order for your study to qualify for this exemption category, the following must be considered:
 What is an educational setting?
Who are the research participants?
What practice is "normal"?
What is not normal educational practice?
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Guide :: Education :: Exempt :: Normal Educational Practice |
