Exempt Criteria 45 CFR 46.104(d)(1)
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.
Additional Requirements and Considerations
- If any subjects are children:
- Investigators must provide a rationale for why a particular age range was selected, indicate their expertise in working with children, describe the adequacy of their facilities for pediatric research, and indicate whether they will have sufficient numbers of children to adequately address the research question.
- All study team members must obtain the required clearances before any interaction with children
- Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.
Privacy & Confidentiality:
- “Anonymous” means that no one can identify the subject at any time.
- “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
- “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
- Data should typically be recorded anonymously or at least coded.
- When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate. (“Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.).
- When children are studied in school or other institutional settings, approval from relevant school official (including the school system IRB or research review committee, if available) must be attached to this application at the time it is submitted to the Pitt IRB
- If educational records may be accessed, see FERPA Guidance