What type of 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.
Although the regulations do not address a maximum risk level, it is implicit within the concept of exempt research that there must be very little, if any, associated risk. Please note that survey 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. (Institutional Review Board Management and Function, Bankert & Amdur, 2006).
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. However, within FERPA [20 U.S.C. 1232g(b)(1)(F)], there are conditions under which student records can be disclosed without parental consent: “Organizations conducting certain studies for or on behalf of the school”. Investigators must contact each institution and follow that institution’s FERPA policy, in addition to the requirements of UConn 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 46 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.
What is normal educational practice?
As noted above, 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.”
The IRB considers educational time to be a valuable commodity, and thus, the design of a research study that will be carried out in an educational setting should be developed with this in mind. At the minimum, the research should not waste student educational time, and may offer benefit to the individual and/or classwide educational experience. The IRB will consider the proposed methodology for the study in light of both time requirements and likelihood of benefit in order to determine whether it qualifies as normal educational practice. In all cases, the IRB will need to assess risks to all proposed participants in the study to determine the level of review required.
In some cases, it may be helpful if the PI can provide a letter verifying that the appropriate school administrator (e.g, principal, superintendent, school board) considers the proposed research study to be normal educational practice. (See Appendix A for an example).
Normal educational practice research that may qualify for exemption
- Development of assessments related to educational activities. The time commitment required to complete assessments should be described and may not exceed reasonable limits. The protocol design should clearly describe how results will be shared back with the school staff to assist in their instructional decisions as well as potential risks that might be associated (i.e., Will students’ grades be affected by their scores on the assessments? Will results be shared at the individual student level or in aggregate? How will the data be used by the school?).
- Research with instructional methods or classroom / school activities which may include pre and post testing, surveys, interviews, and/or observations. For example, if you are studying a new writing technique and you want to ask the students what they think about the writing technique, this could qualify for exemption. However, if you want to ask the students questions that are beyond the writing technique, the IRB may approve the study using the expedited review mechanism, because the questions may not qualify as normal educational practice. In all protocols, it is most helpful to the IRB if you clearly justify the necessity for using the chosen methods for collecting data and specify what data will be collected (via testing or survey instruments, interview questions, and/or observation protocols).
- Collecting data specific to teacher and/or student current knowledge, beliefs, or attitudes towards learning, or data about how these change over time. These studies may be descriptive in nature and may even be longitudinal. Interviews, observations, and surveys must include questions and subject matter that fall within the scope of the educational activity being studied.
- Data collection using videotape, audiotape, and/or photography will be eligible for exempt status only when the materials are accessible only to the researchers and they are destroyed after coding specific to the proposed research. Video and audio taping that is intended for other uses, such as presentation at meetings, publication, or education of graduate students, may not be eligible for exempt status. Please justify the necessity for using these methods for collecting data and specify exactly what will be collected. If the information collected can identify an individual person (i.e., student, staff member), it may be necessary to document signed consent using a consent form. In addition, if the materials will be used in a presentation or publication, it may be necessary to obtain specific permission from parents to do so.
- Obtaining samples of student work or scores may be eligible for exemption if FERPA regulations are met.
Examples of research eligible for exemption under normal educational practices in a commonly accepted educational setting:
Example 1 –
A researcher is interested in implementing an elementary school art education curriculum designed to help students develop visual vocabulary. The curriculum involves asking children to sort cards with reproductions of various Western artists as well as additional related activities. The basic curriculum has been widely used in school settings for over 15 years. The researcher is interested in adding some contemporary artists and those from other cultures to examine whether there are any differences in children’s ability to make discriminations based on visual elements. These additions will not add significant time to the curriculum already being implemented and the assessments used in the study are typical of both length and content of current classroom assessments. Results of the study will be shared in aggregate form so that teachers can determine the benefit of including these curriculum modifications in the future.
Example 2 –
A middle school department of science teachers begins using graphic organizers to improve instruction of English language learners. The school has an existing relationship with the local university to partner on projects of collaborative interest. Thus, the school contacts researchers to ask for assistance in developing appropriate procedures for evaluating the hypothesized improved instructional practices. Researchers plan to use the resulting data in aggregate form for purposes related to presentation and publication as well as providing individual data to teachers to inform their instructional practices.
Examples of research NOT Eligible for exemption under normal educational practices in a commonly accepted educational setting:
Example 3 –
A researcher wants to determine whether providing tangible reinforcement or verbal reinforcement will lead to greater increases in appropriate behavior and decreases in problem behavior for students identified with a serious behavior disorder. Individual students will be chosen for participation from classrooms of the same grade in consultation with the teachers. The students will be as closely matched for age and nature of the disorder, and then randomly assigned to an intervention condition. For example, one student will receive tangible reinforcement, one will receive verbal reinforcement, and the third will be the control.
Example 4 –
Researchers are interested in developing a new assessment for math skills that involve both scoring of written prompts as well as responses involving use of manipulatives. It is expected that a new standardized, norm-referenced product will result. According to the school, the planned assessment is aligned with current curriculum and will not require students to respond to questions that would be unfamiliar. However, the development process entails having students respond to more assessment items than would be expected. In addition, in order to validate the new assessment, additional tests not currently used in the school will be administered for comparison, thus extending total testing time and number of items beyond what would be considered normal educational practice.
Obtaining Parental Permission and Child Assent
In research with minors, even if a protocol does qualify as normal educational practice, the IRB generally requires that parents be notified about the study via a letter sent home with the students (waiver of parental permission with notification). In some cases, it may be appropriate for the letter to be generated from an appropriate school official (e.g, principal) in conjunction with the PI (see appendix B for one example). As noted on the IRB-1 form, to justify waiving parental permission, the IRB must find and document the following:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not be practicably carried out without the waiver or alteration; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after participation in the study.
Depending on the nature of the research, it may be appropriate to offer an ‘opt out’ option whereby parents are provided a notification form about the research study which they may sign and return an included ‘opt out’ sheet to indicate that they do not want their child and/or their child’s data to be included in the study. Note that this type of “passive” consent process still involves waiving parental permission because it is not the equivalent of informed consent.
Non-exempt Studies: Expedited and Full Board Review of Research Conducted in Educational Settings If a research study will be conducted in a classroom setting and it does not qualify for exemption, in most cases, a parental consent form must be used to obtain signed parental permission, and when appropriate, signed assent from the students. A parental permission form must be used to obtain signed permission from at least one parent. The signature of both parents is typically required only for those studies determined to be of greater than minimal risk. Depending on the age of the students, a separate assent form written at an age-appropriate level can be used, or for older students, an added signature line on the parental permission form can be used. Assent must be obtained verbally if signed assent is waived by the IRB.
If the protocol does not qualify for exemption yet it poses minimal risk to participants, it may be eligible for expedited review. If the study poses greater than minimal risk to the participants, the protocol may be reviewed at a full board meeting. If a study poses greater than minimal risk to participants, the PI must ensure that the IRB-1 includes a careful consideration of those risks with a detailed plan for managing them.
Suggestions for completing the IRB application for research in educational settings When submitting an application for research in an educational setting, the following information should be included:
- If the researcher(s) is not directly involved in the implementation of the intervention, particular attention must be paid to the description of how the surrogate researchers will be trained in the conduct of human subjects research (obtaining consent, ensuring that those students whose parents do not want them to participate are excluded from the intervention, etc.) Describe who is responsible for distribution and collection of consent documents. Describe what plan is in place to monitor and manage data collection.
- Describe the plan for handling a student who wants to withdraw from the study after consent/assent has been obtained;
- Clearly describe the difference(s) between what would typically occur in class and what will occur related to the research (i.e., will all students be involved in the same activities or will there be individual students singled out within a classroom?);
- Coercion and undue influence is difficult to avoid in a classroom setting in which activities are determined and implemented by adults. Research designs should include strategies to reduce this risk. For instance, clear procedures should be in place for handling students who are not participating in the study in order to minimize interruption to the typical school day. Although students are generally obligated to participate in activity designed for the whole class, activities specifically implemented for the research need to be clearly explained and alternatives be provided for those choosing not to participate. Appropriate alternatives should be provided for those who opt out, and must be described in the protocol as well as the consent form.
- The risks and inconveniences should be assessed and clearly described in the protocol and consent. For instance, in studies involving examination of classroom management techniques, will individual students be singled out for use of specific techniques? If so, what risks does that present to that child and to the other students (e.g., possibility of increasing in disruptive behaviors)?
- Describe how privacy and confidentiality of all participants (i.e., student, teacher) will be maintained. For example, will study results be shared back with the school on an individual level or in aggregate? Will information about teacher performance be shared with school administration? What risks to participants are presented given how data will be both managed and shared?
Resources and Links
For more information on FERPA, go to www.ed.gov/policy/gen/guid/fpco/ferpa/index.html.
For more information on PPRA, go to www.ed.gov/policy/gen/guid/fpco/ppra/index.html.