The Research Proposal section of a grant application does not take the place of a study protocol focusing on human subjects protections, and should not be uploaded as part of a HUM application (the IRB can access PAFs and AWDs in eResearch Proposal Management (eRPM) when indicated).
A separately uploaded detailed protocol is the best practice for all human subjects research studies involving interaction and/or intervention which require comprehensive IRB review and approval. The IRB may require one if not initially provided.
For externally sponsored studies, the sponsor, lead site, or CRO most usually provides a protocol. Studies initiated by a U-M investigator may use any protocol template that contains all the required information (see heading below). Include a table of contents in the document (.docx or .pdf).
For non-exempt studies with a single IRB-of-record (sIRB) requirement (ceding or accepting oversight), a protocol is required regardless of study design. Studies limited to secondary use (no interaction/intervention), exempt studies, and not regulated projects usually are not required to include a separate protocol document, because these study designs are typically simpler and generally ‘captured’ adequately in the application. Any application type may upload a separate protocol document.
