If your study meets the criteria outlined on this page, please use the Information Letter template for your population instead of Parental Permission and Minor Assent templates or Consent templates. Also, use the Site Permission template to obtain permission from the educational setting administrator (possibly a school principal). All supplemental documents should be uploaded to the application prior to initial submission.
Using a required template is not plagiarism. The information letter template has language that is required by federal regulations. You should not change or revise any of the template language.
A typical research study would require either documented Parental Permission and Minor Assent or Adult Consent, whereas studies related to normal educational practices, and reviewed under Exempt category 1, allow parents/guardians, or adult participants, to opt their child's, or their, data out of the study via an Information Letter.
According to CFR 45 part 46.104.d(1), exemption can be applied to the following: “Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”
To qualify for exemption under normal educational practice, the Principal Investigator must demonstrate that the study is conducted in a commonly accepted educational setting, that the topic of the study involves normal education practices, and that the study won’t impact students’ and/or educators’ ability to learn or provide instruction. The information letter is typically sent to parents/guardians, or adult participants, via internal communication channels within a school or through email.
You will upload your information letter document to your IRB application.
The document you upload to your IRB application should be complete and ready to use. Double-check the following: