Research Plan

The purpose of the Research Plan is to describe the proposed research in sufficient detail so that the Institutional Review Board (IRB) can determine if approval criteria for human subjects research defined in federal regulations (45 CFR Part 46 and 21 CFR Parts 50, 56, 312 and 812) is met.

The Research Plan is a narrative of the study and is a living document to be maintained over the life of the protocol. A Research Plan is required for every protocol submitted for IRB review


Print Research Plan Guidance

General Considerations