MCW Human Subject Research Project Submissions
Research teams must submit new projects, amendments, reports or events via eBridge SmartForm.
HSR Project Submissions
Who Can Serve As A Principal Investigator?
A Principal Investigator has overall responsibility for the conduct of a research project, including all technical, programmatic, financial, compliance and administrative aspects. MCW defines a Principal Investigator as any individual who:
- Leads or directs a research project involving human subjects
- Performs activities that engage MCW, FH or Versiti Blood Research Institute in anyone else’s research project
- Uses MCW, FH or BRI resources; including lab equipment, physical space, or services
- Brings research data onto the campus (MCW, FH or BRI space)
- Performs any research activity on MCW, FH or BRI campus
The Principal Investigator is responsible for controlling the technical direction and academic quality of the project, and will ensure that the project is carried out in compliance with the terms, conditions, and policies of the College and the Sponsor when applicable. Learn more about PI eligibility requirements. To learn more about Principal Investigator policies and requirements for investigators conducting research at Children's Wisconsin (CW), researchers can find information on the CW Internal Website (CW Connect access required).
eBridge SmartForm Instructions
SmartForm Instructions help provide regulatory context and guidance. HRPP Office has developed these guidance documents to assist research teams when completing an eBridge SmartForm for human subject research.
- PRO SmartForm Instructions (DOCX)
- CPR SmartForm Instructions (PDF)
- AME SmartForm Instructions (PDF)
- PRO SmartForm Instructions for Use of De-Identified Human Tissue (PDF)
Registration Projects & FLEX Review
MCW HRPP Office has developed worked with research teams to various review pathways to support the variety of research being conducted by MCW, Froedtert Health and Versiti Blood Research Institute Faculty. This includes our local FLEX review process and use of MCW HRPP designated Public Data Sets. Learn more about Registration Projects & FLEX review.
Public Data Sets
Per 45 CFR 46.101, research using certain publicly available data sets does not involve “human subjects.” The data contained within these specific data sets are neither identifiable nor private and thus do not meet the federal definition of “human subject” as defined in 45 CFR 46.102. Therefore, these research projects do not need to be reviewed and approved by the Institutional Review Board, (IRB). MCW HRPP office has worked with a number of investigators to identify and classify numerous data sets as "publicly available data sets" or "restricted use data sets." Learn more about Public Data Sets
Is There a Fee for Project Submissions?
There are three instances where the MCW IRB Office will assess a fee for the review of a research project:
- an industry sponsored clinical trial
- when MCW is serving as the single IRB for a study
- when MCW relies on an external IRB for an industry sponsored study