What type of education research study qualifies for exemption?
Federal regulations allow specific categories of human subjects research to be exempt from continuing IRB review (45 CFR 46.101(b)). Category 1 applies to research conducted in schools and other education settings:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Please note that survey or interview research involving children is not exempt, nor is observation of a minor’s public behavior unless the investigator does not participate in the activities being observed.
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, such as Subpart D of 45 CFR 46, FERPA (Family Educational Rights and Privacy Act), and PPRA (Protection of Pupil Rights Amendment). Subpart D specifically deals with children as a vulnerable population and most protocols that qualify for normal educational practice deal with children. If the IRB determines that a research study does not qualify for exempt status, then the extra protections for minors under Subpart D apply. Additionally, FERPA restricts researchers’ access to student records without written permission from parents. Investigators must contact each institution and follow that institution’s FERPA policy, in addition to the requirements of the IRB. Finally, PPRA outlines 8 categories of protected information for survey responses and requires that parents be afforded the right to inspect surveys before they are given to students (for more information on FERPA and PPRA, see the link at the end of this section).
What is an educational setting?
45 CFR 46Â does not specify that normal educational practice takes place in schools only. The IRB defines an educational setting as any setting where an educational experience takes place. For example, a public school, an after-school club or program, a Boy or Girl Scout meeting, a professional development seminar for school district personnel, or a postsecondary education setting.
Who are the research participants?
The participants should include those involved in the educational experience, which most likely will include the teacher(s), student(s), and possibly the administrator(s). Participants that are indirectly involved in the educational experience may be included in the study, but they may not be exempt under normal educational practice, thus requiring additional consent procedures. For example, interviewing a principal may require that you use a consent form because this occurs outside the classroom and may not be considered normal educational practice. Participants can include populations with special educational needs, though the IRB will require demonstration of the investigator’s credentials to work with these vulnerable populations as well as clear explanation of any additional procedures to minimize risks specific to working with this population. For example, if a child is significantly cognitively delayed, obtaining assent may not be appropriate, and the investigator must describe what steps will be taken to ensure that appropriate cues are taken from the child that may indicate an unwillingness to continue with study procedures.