MCW Human Subject Research Project Submissions

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.

IRB SOB: Defining and Determination of HSR (PDF)

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
  • Research teams must discuss any addition of outside project location with the MCW IRB Reliance team

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.

IRB SOP: Continuing Progress Reports (CPR) (PDF)

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.

IRB SOP: Reportable Events (PDF)