For research awarded funds under 34 CFR 356 by the U.S. Department of Education for fellowships involving disability and rehabilitation research, the protection of human subjects 34 CFR 97 is applicable subject to an additional requirement.
That requirement specifies that when an IRB reviews research that purposefully requires inclusion of children with disabilities or individuals with mental disabilities as research subjects, the IRB must include at least one person primarily concerned with the welfare of these research subjects.
When a human research study submitted to the MSU Human Research Protection Program may involve a fellowship awarded under 34 CFR 356 (Merit Fellowship, Distinguished Fellowship), the study will be assigned to an IRB Administrator for review of the funding. If 34 CFR 356 may be applicable, the IRB Administrator will assign the Compliance office. The Compliance office will communicate with the IRB if 34 CFR 356 is applicable. The IRB chair or an IRB member will determine if the research purposefully requires inclusion of children with disability or individuals with mental disabilities as research subjects. If the research does require such inclusion, an IRB member primarily concerned with the welfare of these research subjects will be included in the review of the research.
See 34 CFR 356.3(c)(1) and 34 CFR 356.3(c)(2).
This policy and procedure supersedes those previously drafted.
Approved By: Vice President of Research and Graduate Studies, 12-9-2015. Revision 1 approved by Assistant VP Regulatory Affairs on 8-16-2019.