Policy Statement

In accordance with federal regulations including but not limited to 45 CFR 46, 21 CFR 50 and 56, 38 CFR 16 and 17; related guidance documents and memoranda, and Nevada state law, all non-exempt human subject research conducted by University and affiliate investigators will be overseen by an Institutional Review Board (IRB).

Reason for Policy

The policies and procedures of the OHRP, University policy and federal regulations require that research involving human participants be subject to oversight by an IRB to ensure that the rights and welfare of research participants are protected and that the research meets regulatory and institutional requirements.

This policy defines which projects must be reviewed and overseen by an IRB, which are exempt from IRB review but require oversight by the OHRP, and which are excluded from the approval requirements of this policy. This policy also identifies when investigators should consult with OHRP staff or analyst, an IRB chair or member, IRB-promulgated guidance, or a combination of resources in determining when their project requires a formal determination by the IRB that the project does not require IRB approval or OHRP oversight.