Appendix D

Guidance on K-12 School Based Research

1. Overview: Research conducted in schools raises a distinct set of concerns with regards to protection of research participants. In addition to the usual requirements of IRB review, an investigator who intends to conduct research in a school needs to be aware of these issues when designing a research study. In particular, research involving K-12 students raises issues regarding appropriate consent methods, influence of peer pressure, confidentiality concerns and the desire of students to please teachers and parents. The guidance below describes some of the more common issues which have come to the attention of the IRB. The IRB is available to assist investigators in determining what issues are likely to arise in a particular study.
2. Consent and Assent: Participants in school-based studies are likely to be minors and thus not able to give legally effective consent. The minimum age at which an individual can consent to research participation varies from state to state and may be distinct from other consent statutes such as ability to consent to medical treatment. The laws of the state in which the study is conducted are the ones to be followed. In Arizona, only subjects over the age of 18 can legally consent to participate in research. Written parental permission is required for all participants under the age of 18 except in rare cases as determined by the IRB. Despite their inability to legally consent, ethical standards require that the autonomy of minors be respected by requesting assent to participate. Assent is similar to consent although the information provided to gain assent must be tailored to the intellectual capacity of the children. For example, a form similar to the parental consent form may be appropriate for high school seniors whereas a less detailed verbal description may be most appropriate with kindergartners. Most research should only proceed when both the parent and the child have agreed to take part in the study.

3. Limits to Confidentiality:Most studies promise confidentiality of the student’s responses. When this promise is made, it is absolute. The only instances in which it can be breached involve state-mandated reporting requirements (abuse, some infectious diseases, etc.), prevention of harm to the participant or others, and subpoena. The promise of confidentiality is to the student and their parent or legally-authorized representative. Thus, in cases where there is a need to intervene, it is not considered a breach of confidentiality to contact the parents. The one exception would be circumstances in which it would be more damaging to the child for the parents to be informed, such as instances of child abuse. In such cases, it may be prudent to consult the child first. These limitations of confidentiality must be conveyed to the students, including under what circumstances their parents would be informed of their responses.

   Providing information about an individual participant to anyone other than the student and parent/guardian is considered to be a breach of confidentiality. This includes providing individually identifiable information to the schools, whether or not it is in the student’s best interest. Although the school is often thought of as a partner in the research, they are nonetheless not automatically privileged to see the individually identifiable data. The confidentiality promised to the students and their parents/guardians would govern any potential disclosure to the school and should be considered and discussed with the school prior to initiating the research.

   If the information to be collected in the study includes criminal activity (drug use/sale, violence to others), and it cannot be collected anonymously, then the investigator may need to apply for a Certificate of Confidentiality from the Department of Health and Human Services (DHHS). This document protects the data from subpoena, and thus removes the risk of use in criminal proceedings. Receipt of a Certificate of Confidentiality does not alleviate legal or ethical requirements to report child abuse. It should be noted that even in cases where a Certificate of Confidentiality is not presumed to be needed; access to research data may be sought via subpoena. For example, one can imagine that the child’s responses could be of value in the context of a custody dispute. In most studies, the likelihood of a litigant wanting to look at the data are low and confidentiality can be adequately protected by coding the data and destroying the code upon completion of data collection.

4. School Concerns: One could argue that the concerns of the school are not within the purview of the IRB as a school is not a “subject” since it is not a “living individual.” Nor is the school part of the research team since they often will not be involved in the design and conduct of the research. However, since a school study cannot, by definition, be conducted without the approval of the school, sensitivity to their concerns will facilitate a researcher’s ability to complete the proposed data collection and produce valid results.

   The primary function of a school is to educate students. Involvement in a research study will necessarily compete for the limited time that a school has to perform its primary function. The moment an investigator enters a school, the education function of the school has been disrupted. Such disruption will only be tolerated by the school if it anticipates receiving some benefit from participation. In agreeing to participate and to allow access to its students, the school must weigh the disruption of the study against the expected benefits. To do so, the school must be fully informed about the details of the study, much like the requirement for an individual participant’s informed consent. It is imperative that the investigator clearly describes the roles of all parties, the risks and benefits of the study, as well as the purpose and procedures of the study.

1. Define who is responsible for what: There is a broad spectrum of the intrusiveness of a study. At one extreme are observational studies in which the investigator is interested in discreet observation and thus only approval to enter the schools is needed. Purely observational studies would not require parental consent, although the school may require that the parents are informed of the research.

   Most common, however, are studies in which the data are collected interactively on school grounds during the school day. The responsibility of the schools may possibly include distribution and collection of parental consent documents. The testing session itself may occur during normal classroom time, either with the class being testing en masse or by individuals being excused from the class to meet with the investigator. When the data is collected en masse, it is frequently the responsibility of the school to determine appropriate alternate activities for those students who decline to participate. It should be noted, however, that in some cases it is preferable to have a “filler” activity for the non-participants. In this way, the confidentiality of those who chose not to participate can be respected by allowing the appearance of participation in front of their peers and teachers while completing an unrelated task.

   In defining the roles of the research team and the schools, the research personnel who will be on site should be identified to the school along with their qualifications and role. The school should be forewarned about who will be present in the schools, when they will be present and in what capacity. This includes undergraduates on the project as well as graduate students and postdoctoral fellows. To facilitate the school’s ability to monitor who is present in their facility, the IRB recommends that all research personal wear a visible form of identification which indicates their name and their affiliation with the research project.

2. Define benefits to the school: As noted, schools are only willing to relinquish classroom time if they feel that the benefits of the study are worthwhile. A realistic description of the benefits for the school should include not only what benefits will be provided but also what the limitations of these benefits are. For example, the types of reports which will be provided to the schools must be outlined—will there be information specific to an individual school or to schools in general? Are there circumstances in which the study will be terminated early and thus reports not be provided? This latter instance must be addressed if a study commences prior to securing adequate funding. The IRB recommends that the school be provided with a timeline showing when the data will be collected and when the school can expect to see any promised reports or other benefits.

3. Define disclosure risks: Public schools in particular have legal and moral requirements which they must fulfill to ensure the safety of their students. For example, school personnel in Connecticut are mandated to report suspected child abuse to state authorities. Such reports are frequently followed by an investigation by DCF and have the potential to have a child removed from the home. The threshold of required reporting is low and schools are put into a difficult situation when informed of suspected abuse of an identified student. Investigators should consider the potential to obtain information that would necessitate DCF reporting and whether such information should be shared with the school or handled directly by the investigator.

   Another area where the school would be expected to act also includes threats to student safety. Information suggesting that a student may harm another student or him/herself would require the school to further assess the threat. Should the threat be substantiated, the school would be expected to mitigate the situation. Although it would be difficult to identify all situations in which a response would be necessary, investigators should be prepared when the study queries about depression, possession of weapons, or threatening behavior, either directly or indirectly. The IRB protocol should propose a plan for handling such information including to whom the information will be disclosed.

   To protect the school from having to implement its mandated procedures, it is generally better for the investigator to take responsibility for information uncovered in a study and present the school with generalized results. Reporting would then be performed by the investigator directly to the relevant authorities. Note that many reporting requirements are defined by each individual state. Investigators are urged to be aware of what they as researchers would be legally required to report, as well as what they as individuals may feel ethically required to report. In cases where it would be absolutely necessary to inform the school, the school and the participants must be informed from the start that this would be a potential risk involved in the study. This risk must be stated clearly and in writing, including what types of actions the school would be required to take and whether or not the information would become part of the student’s school record. The investigator must discuss reporting expectations with the school personnel prior to the initiation of a study.

4. Define other site specific risks: Each school is a unique environment about which the school personnel are experts. Survey instruments and other measures, which are of little concern in one school, may be of great concern in another, based on the local culture. It is essential that investigators provide school administrators with a full set of the measures to be used so that they may assess the likelihood of problems for their school. The school should be asked if the measures are appropriate for their students and if any problems can be anticipated during or after the research procedure. Note that highly sensitive topics may promote discussion of these issues by the students during the remainder of the school day. Depending on the nature of the issues, the school may want to be prepared for any subsequent repercussions arising from the research participation. Hence, the school must be aware of what measures will be administered when.

5. Define appropriate contacts: Communication is essential to maintaining rapport with the schools. Not only does the school need to be informed as to who they should contact with questions and concerns, but also, the investigator will need to know who the appropriate contacts are for various aspects of the study. The individual with authority to allow access to the students is usually different from the person who should be contacted about the logistics of data collection. In any case, these individuals should be defined up front to facilitate future communication.

   Obtaining approval to work in the schools is a multi-step process. In the end, written approval should come from the highest level. In public schools this may be the superintendent. For private schools, the headmaster may be the appropriate official. This individual will be required to sign a letter indicating that they agree to allow access and have been shown all the required materials. To facilitate this process, the IRB will provide the investigator with a study specific checklist which is to be attached to the letter. This checklist will indicate all the relevant measures and responsibilities inherent in participation.

5. Schools as Research Partners: Occasionally, the study will call for the school to play an active role in the design and/or conduct of the research. Once the school moves beyond merely providing access, it is considered to be “engaged in research” and must meet additional requirements under the regulations for federally funded research if applicable. In particular, the school would be required to file an assurance with OHRP, indicating their plans to comply with 45 CFR 46. The IRB will assist in determining when such an assurance is needed and how the school can comply with this requirement.
6. Reporting Issues Arising in the Course of the Research: Occasionally, there will be problems during data collection. Whether or not these problems were anticipated, they should be reported to the IRB. Problems can range from complaints or distress of a participant to identification of participants at risk of harm. Whether or not the event is expected, if there is an outcome which is detrimental to the participant or perceived as detrimental, then a reportable/adverse event has occurred. If the event requires investigator intervention or alteration of procedures then the event must be reported within 5 business/working days. Otherwise, the events may be reported annually via the renewal application. Note that the IRB has experience in ways to handle such events and is available to assist the investigator to determine the appropriate course of action.
7. Exempt Studies: 45 CFR 46 exempts “research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special educational instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.” Thus, studies which focus on improving the educational experience of the students are not covered by the regulations. GCU policy, however, requires that the exempt status always be determined by the IRB. Please see Guidance on Exempt Research for additional information.
8. FERPA and PPRA
   Schools that receive funding from the US Department of Education are required to comply with the Family Educational Rights and Privacy Act (FERPA, 34CFR49) as well as the Protection of Pupil Rights Amendment (PPRA, 34CFR98). Under FERPA, schools may not release identified student academic information without authorization from the student (if over 18) or parent/guardian. PPRA requires that consent be obtained for any surveys involving sensitive information and that such surveys be available for review by parents prior to their administration to students. Investigators are reminded to take these regulations into account when planning research involving schools.
9. PROCEDURE INFORMATION:
   RESPONSIBLE OFFICE: Office of Academic Research
   POLICY NUMBER: 3.1.3
   SECTION: 3.0 Vulnerable Populations in Research
   REVIEW RESPONSIBILITY: IRB Director
   ORIGINAL CREATION DATE: January 3, 2011
   APPROVAL DATE: February 2, 2011
   REVISION DATES: