IRB Review Needed?

Applicability

The Michigan State University Human Research Protection Program policies and procedures apply to the human subject research and/or clinical investigations conducted by employees of MSU (faculty and staff), by students of MSU, by agents of MSU (i.e. individuals engaged by MSU to conduct human subject research on behalf of MSU), or by individuals conducting research at entities that have a formal written agreement with MSU for review and approval of their human subject research. HRPP Manual Section 4-1 Applicability.

Research Involving Human Subjects

When an activity meets the definition of “research” and involves “human subjects,” the DHHS regulations regarding the protection of human subjects apply, with limited exceptions outlined in Human Research Protection Program (HRPP) Manual Section 8-8 “Demonstration Projects.” HRPP Manual Section 4-3 Determination of Human Subject Research.

Clinical Investigation Involving Human Subject(s)

When an activity meets the definitions of “clinical investigation” and “human subject,” the FDA’s regulations regarding the protection of human subjects also apply (e.g. 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812). HRPP Manual Section 4-3 Determination of Human Subject Research.