75. Department of Education (DoEd) Regulations for Human subject Research (34 CFR 97)
DoEd adopted the Common Rule, Subparts B, C, and D with additional directives to protect the privacy of educational records (see FERPA policy below) and the rights of families and students (see PPRA policy below).
For research that purposefully requires inclusion of children with disabilities or individuals with mental disabilities as research subjects, DoEd regulations require the reviewing IRB to include at least one person primarily concerned with the welfare of these research participants. The University IRBs comply with this additional regulation.
DoEd regulations include the following definitions:
- Research or experimentation program or project means any program or project in any research that is designed to explore or develop new or unproven teaching methods or techniques.
- Children are persons enrolled in research not above the elementary or secondary education level, who have not reached the age or majority as determined under state law.
The IRB requires an additional investigator form for DoEd research to verify that investigators address IRB-relevant elements of the additional DoEd regulations.
In presenting the protocol to the IRB, the primary reviewer will address the additional DoEd regulatory requirements.