August 28, 2020: COVID-19 Update
Before the IRB will approve in-person research that takes place within an organization outside of Lehigh, including within K-12 schools and preschools, the organization or school district must give permission for in-person research to take place. If permission to conduct research within an organization or school district was obtained prior to closure of Lehigh’s campus on 20-Mar-2020, permission must be re-issued. Documentation of permission from the organization must outline all in-person research activities that will take place on the organization’s premises. The letter must be signed and dated. All research that takes place within an outside organization must follow all rules imposed by the organization or school district, as well as Lehigh’s requirements for conducting in-person research.
Schools are organizations that have the right to approve or reject the conduct of human subjects research activities. Lehigh’s IRB requires researchers to submit documentation of permission from a school administrator before conducting research activities within a school. This guidance provides specific guidelines for obtaining a school administrator’s permission.
All researchers who wish to conduct research within preschools, daycares, or K-12 schools must submit a letter or an email stating that they have received permission from the appropriate school administrator. This includes research in which students, teachers, school staff, or school administrators are the participants. Researchers must also obtain documentation of permission in order to recruit participants from schools, even if information will not be collected from participants on school premises. Documentation of permission must be submitted to the IRB and must be approved before any research activities take place. Documentation of permission must be submitted through IRBNet in addition to all other materials required for IRB review.
Researchers are expected to contact school districts to determine the appropriate authority from whom they must receive permission. Schools may require that permission is granted by the district superintendent, school principal, or by an internal committee. (For example, Allentown Area School District requires all requests for research within the school district to be approved by their Research Review Committee.)
Final IRB approval to conduct research activities in a K-12 school, preschool, or daycare will not be given until the researcher has submitted documentation of permission to the IRB, and the submission has been approved. If a school requires IRB approval before granting their own permission, the researcher may request that the IRB issue an conditional approval letter stating that final approval is conditional upon the IRB’s receipt of documentation of permission from the school.
Parents must provide consent for their children to take part in research studies at school. Please present the plan to collect parental consent forms in your Human Subjects Research Application Form. When appropriate, children should also provide assent. See Children as Research Subjects for further guidance on parental consent and child assent.
When describing your research methodology in the Human Subjects Research Application, please make it clear which aspects of the study fall outside of normal classroom activities. If your research methodology involves an activity that is designed for the entire class to take part in, please describe alternative activities for children who do not assent to take part in the study, or whose parents did not consent for their child to take part.
See FERPA Guidance for information on using students’ educational records.
Documentation of Permission
Researchers may submit a signed letter of permission from a school administrator OR submission of an email from a school administrator authorized to provide such permission.
Letters of permission from a school administrator must contain the following elements:
- Letter must be printed on the school/school district’s letterhead.
- Letter must include the name(s) of the researcher(s) to whom permission is being granted, including the primary investigator.
- Letter must express that the person granting permission understands the scope and duration of the study.
- Letter must include the signature of the administrator who is granting permission, as well as the administrator’s printed name, title, and contact information.
Alternatively, a school administrator may provide permission via email. Any email expressing permission from a school administrator must contain the following elements:
- Email must be sent directly from the person with the authority to grant permission, and his or her email address must be able to be verified as associated with the school on the school’s website.
- Email must include the email signature of the administrator who is granting permission, including his or her name, title, and contact information.
- Email must include the name(s) of the researcher(s) to whom permission is being granted, including the primary investigator.
- Email must express that the person granting permission understands the scope and duration of the study OR it must document that the full scope and duration of the study has been explained to the administrator in a previous email sent by the researcher.