Human Subject Research Project Submissions
Research teams must submit new projects, amendments, reports or events via eBridge SmartForm.
HSR Project Submissions
Research teams conducting human subject research (HSR) will encounter a number of these submissions as part of the life cycle of a project. Additional guidance is provided under each topic.
Medical College of Wisconsin (MCW) commits to apply its ethical standards to all Human Subject Research (HSR) regardless of funding source.
MCW IRB Office must review all HSR in which MCW is engaged in accordance with MCW Corporate and IRB policies.
Investigators must submit all research to the HRPP Office for review via the eBridge system. Human subjects research activities must not begin until the project team receives the official IRB determination letter via eBridge.
The IRB will make the ultimate determination regarding whether a human subjects research project requires review at a convened IRB meeting or whether it can be processed via one of the minimal risk pathways. For a human subjects research project to qualify as minimal risk, all research activities must qualify under federal determinations of Exempt or Expedited research (45 CFR 46.104 and 45 CFR 46.110), and/or institutional categories defined in IRB SOP: Registration Projects: Human Subject Research Projects which Qualify for FLEX Review. If any research activity at any site is more than minimal risk – regardless of whether the MCW IRB is reviewing said activity – the project must undergo review at a convened meeting.
- When MCW is engaged in HSR that is conducted, funded, or otherwise subject to regulatory requirements by a federal department or agency who is a signatory of the Common Rule, MCW IRB commits to apply the regulations of that agency including HHS relevant to the protection of human subjects.
- When the MCW is engaged in HSR involving an FDA-regulated product, MCW IRB commits to apply the FDA-regulations relevant to the protection of human subjects.
Questions about whether a project meets the regulatory definitions of HSR, teams should contact the IRB office to provide a determination or additional guidance.
Investigators who wish to change or revise an ongoing IRB-approved research project, teams must submit an amendment to the IRB and receive IRB approval before implementing any modification.
When research teams identify or receive an amendment for to the approved project, they must submit the amendment promptly to secure final IRB approval within approximately 90 days from notification of the change. Research teams should work to respond quickly to any IRB-requested modifications to meet this expectation.
This timeframe ensures the changes can be implemented in a timely process to protect the rights, safety and welfare of their subjects and the continued conduct of the project in accordance with the protocol.
Examples of changes that need review by the IRB include but are not limited to:
- Change in PI- This change requires the new PI to complete and sign the Agreement of Investigator Responsibilities (DOCX) and should be uploaded with the eBridge AME submission.
- Changes in key personnel
- Increase or decrease of enrollment numbers
- Change in recruitment methods
- Changes in the consent form
- Changes in an Investigator Brochure or device information
- Change in procedures or randomization
- Adding or dropping an arm of the project
- Changes in questionnaires, surveys, interview scripts, advertising
- Changes in funding
- Changes in the title of the project
- Addition of new study sites or locations which will be under the direction of the Principal Investigator
IRB SOP: Amendments (PDF)
In accordance with HHS and FDA regulations 45 CFR 46.109(e), 21.CFR 56.109(f), a continuing progress report must be submitted for review and approval at intervals appropriate to the degree of risk, but not less than once per year. Factors for making the decision about the frequency of review include the level of risk, location of the study, and any other factors that might affect the welfare of the subjects. Frequency of review is determined by the IRB upon initial review and each subsequent continuing progress report review.
Refer to the IRB CPR policy along with the CPR SmartForm Instructions for more information and instructions on how to complete a CPR in eBridge.
MCW IRB has relied upon the eBridge system to process IRB applications and projects since 2005. As projects evolve over time, MCW IRB requires use the review of non-exempt human subject research that continues beyond six years from the initial date of approval.
In 2016 MCW IRB implemented a 6-year renewal process for ongoing non-exempt human subject research projects. On-going projects will be prompted to submit an updated PRO SmartForm at the time of their 6th year continuing progress report.
The 6-Year Renewal process is:
- An institutionally required process that allows you to update your eBridge PRO SmartForm every 6 years
- Submitted & reviewed in conjunction with your CPR (Continuing Progress Report)
- Involves completion of the CPR SmartForm along with reviewing existing response within the PRO SmartForm and answering new questions (if applicable) within the Modified Study SmartForm
- All currently approved Full Committee and Expedited projects will complete the 6-Year Renewal process.
- Exempt studies are not required to renew.
IRB SOP: 6-Year Renewals (PDF)
The Federal regulations (45 CFR 46.1 03(b)(5) & 21 CFR 56.1 08(b)) require written procedures for ensuring prompt reporting of unanticipated problems to the IRB, appropriate institutional officials, any supporting department or agency head (or designee), and OHRP.
The purpose of prompt reporting is to ensure that appropriate steps are taken in a timely manner to protect subjects from avoidable harm. Investigators must promptly report any Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO) or events which may constitute Serious and/or Continuing Non-compliance associated with their research project in accordance with IRB policies.
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.
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