Investigators and Study Staff

Working with Froedtert Health System

If you are looking to conduct your research at any Froedtert Health (FH) System entity (Froedtert Hospital, Community Memorial Hospital, St. Joseph West Bend or any of our clinics), and/or utilize any FH resource for your research (not all inclusive- staff, equipment, supplies, images, protected health information) your project must be reviewed by and receive FH Administrative Approval through the FH Office of Clinical Research & Innovative Care Compliance (OCRICC).   OCRICC recommends that you contact OCRICC no later than submission to the IRB. You can contact us by e-mail or visit our SCOUT site 

 New Studies

New Studies - Determining if a Proposal Needs IRB Review 

The following definitions and questions are designed to assist the IRB and investigators with deciding if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.  While this guidance is provided to investigators for informational purposes, it is the responsibility of the IRB to make the final determination about when research requires IRB review and oversight.  If you answer yes to any of the below, Investigators must create and submit their project to the MCW/FH Institutional Review Board for review and approval prior to beginning the work.

1. Are you conducting Human Subjects Research?

Human subject means a living individual who is or becomes a participant in research, either as a recipient of the test article or as a control about whom an investigator (whether professional or student) conducting research obtains:

     1.  Data through intervention or interaction with the individual, or
     2.  Identifiable private information

2. Are you conducting research with decedents?

Research with decedents is not governed by the Office of Human Research Protection or the FDA. However, this type of research is governed by HIPAA regulations and must be submitted for review to the MCW/FH HRPP office. 
 

3. Unsure if you are conducting Human Subject Research?

Use the OHRP Decision Charts to help determine if your project constitutes human subject research.  The Office for Human Research Protections (OHRP) provides graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46.

 

Do I need to make a submission if I'm conducting Not Human Subject Research?

Non-Human Subject Research is defined as:

  • A systematic investigation in which
  • Data/samples from living individuals are obtained:
    • To develop or contribute to generalizable knowledge
    • Without intervention or interaction and
    • Include no identifiable private information (e.g. de-identified data/specimens)

Because an incorrect guess by the investigator might have serious consequences, proposals that may not meet criteria for human subject research should be submitted in eBridge or via our paper application for IRB determination. An investigator who fails to submit an IRB application will be found to be in serious non-compliance if later found to be engaged in HSR.  

Who can submit studies?

Refer to IRB SOP: Requirements & Qualifications to Serve as a Principal Investigator regarding who can act as the Principal Investigator for studies at MCW.  More...

Coordinated IRB Review

Learn more about multi-site site projects and established IRB Partnerships with other institutions (DOCX)

MCW/FH Other Committees that may need to review a new study

Some new protocols may require review by various administrative or ancillary committees prior to being reviewed by the IRB. Investigators should be aware of these processes when planning to submit a new study to the IRB. The following are examples of ancillary committee which may need to review a submission prior to IRB review:

 

 Amendments

Submitting Changes to a Study

Per MCW IRB SOP: Modifications to an Approved Protocol; Investigators who wish to change or modify an ongoing IRB-approved research study, must submit an amendment to the IRB and receive IRB approval before implementing any modification.

When an Investigator receives an amendment or a request for change to the approved project, they must submit the amendment promptly to secure final IRB approval within 90 days from notification of the change.  In addition, Investigators and study teams should work to respond quickly to any 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

• 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 MCW/FH Principal Investigator

  • Investigators must include the IRB approval documents from the outside institution or contact the HRPP office to discuss the option of coordinated reviews.

 

 Reportable Events

Requirements for Reporting to the IRB

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) associated with their research project in accordance with MCW IRB SOP: Requirements for Reporting to the IRB.

Events which meet MCW’s Prompt Reporting Criteria

a) Any Adverse Events (internal or external) that meet all of these criteria:

  • Unexpected
  • Possibly, probably, or definitely related to the research
  • Suggests the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized.

Examples include but are not limited to the following:

  • Unanticipated adverse events (either occurring internally or at an external site) which meet the criteria above
  • Unanticipated adverse device effect
  • External Serious Adverse Events that meet the criteria above
  • A series of adverse events that meet the criteria above
  • New information that might affect adversely the safety of the participants or the conduct of the clinical trial
  • Any change significantly affecting the conduct of the clinical trial or increasing the risk to participants
  • New findings that result in premature closure of a study or are related to an unanticipated problem involving risks to subjects or others 

b) Follow-up reports to initially reported Adverse Events which meet all of the above criteria


c) Unanticipated Problems or any incident, experience, or outcome that meets all of the following criteria:

  • Unexpected with reference to procedure/risks defined in initial IRB application
  • Possibly, probably, or definitely related to participation in the research study, and
  • Suggests the research places subjects or others at greater risk of harm than was previously known or recognized.

Examples include but are not limited to the following:

  • Breach of privacy or confidentiality including lost or stolen study records that contain private identifiable subject information.
  • Any other problem that the investigator considers to be unanticipated and indicates that subjects or others are at increased risk of harm.
  • Incarceration of a subject in a protocol not approved to enroll prisoners.
  • Complaint of a subject when the complaint indicates unexpected risks or cannot be resolved by the research team.

d) Safety Notice/Report from Sponsor or Central Site if report describes new information regarding risks or unanticipated problems involving risks.
 

Examples include but are not limited to the following:

  • Sponsor imposed suspension for risk.
  • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol.
  • Any safety reporting requirements specified by the IRB as a condition of approval.
  • A paper is published from another study that shows that the risks or potential benefits of the research might be different from those initially presented to the IRB.
  • Suspension or Termination of the Study by the Sponsor

e) Report from a Data Safety Monitoring Board (DSMB) or Equivalent if the report describes new information regarding risks or unanticipated problems involving risks.

Examples include but are not limited to the following:

  • An interim analysis or safety monitoring report indicates that the frequency or magnitude of harms or benefits might be different from those initially presented to the IRB.

f) Significant Protocol Deviation
 

Examples include but are not limited to the following:

  • Any departure from the protocol (deviation or violation) that harmed subjects or others; that indicates subjects or others might be at increased risk of harm; or that compromises the integrity of the research data.
  • Any change made to the research without prior IRB approval in order to eliminate apparent immediate harm

g) Planned Protocol Deviation which increases the risk to participants or others, decrease potential benefits of the study, or undermines the scientific integrity of the study. 
 

Examples include but are not limited to the following:

  • Enrolling a subject who does not meet eligibility criteria
  • Not performing a specific screening procedure for a patient as indicated in the protocol

h) Non-Compliance with IRB Policies and/or Procedures
 

Examples include but are not limited to the following

  • QI routine review reports which recommended immediate reporting of events
  • Any allegation of non-compliance with protocol requirements (including protocol deviations or violations) or IRB policies.

 

 

 

 Continuing Review

Submitting Continuing Progress Reports

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 IRB SOP: Submission of Continuing Progress Reports (CPR) for more information and instructions on how to complete a CPR in eBridge system

 Coordinated IRB Review

Coordinated IRB Review

Projects or clinical trials that involve more than one institution inherently have extra issues that need to be considered by the study team and the IRB. Some of these issues are related to the logistics of conducting the project at other institutions and some are related to obtaining IRB approvals from each institution. Investigator responsibilities when conducting a multi-site study are listed below. Because the term “multi-site” is used to describe a variety of studies, it’s important to understand the definition from which the IRB is working when considering IRB review of these projects.

Multi-site Definition

Not all projects involving more than one institution are considered multi-site studies.

  • Examples of multi-site projects:

o   Medical College of Wisconsin (MCW) investigator conducting an intervention study at MCW/Froedtert Hospital (FH) and sharing identifiable data collected for that study with researchers at the University of Ohio.

o   MCW/FH participating as one site in a multi-site clinical trial, for example cooperative oncology group studies.

o   Adjunct faculty from UW-Milwaukee conducting a study at MCW/FH with FH patients and sending data to UW-Milwaukee for analysis.

o   MCW investigator conducting retrospective chart review of patients at Children's Hospital of Wisconsin (CHW).

  • Examples of projects that are NOT multi-site:

o   MCW investigator conducting a drug study at the Eye Institute.

o   MCW investigator conducting a study at MCW/FH and the MCW Sports Medicine Clinic.

IRB Review of Multi-Site Projects

The IRB is interested in making the IRB review process more efficient whenever possible.  To that end, the MCW/FH IRB has developed partnerships with other institutions through which certain types of studies may be eligible for review by a single IRB.  IRB Authorization Agreements have been set up between the institutions within these partnerships that allow one IRB to rely upon another for certain studies. In some cases, the MCW/FH IRB may consider IRB Authorization Agreements with institutions outside these partnerships.

Investigators should be aware, however, that there is a formal process for requesting that the IRB consider a single IRB review. Deferral is not automatic and not every request for a single IRB review will be granted. The PI will be notified when the IRB has made its determination.

Requesting a Coordinated IRB Review

Before submitting an application to the IRB, the investigator should submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office.

Established IRB Partnerships With Other Institutions

  • Southeastern Wisconsin CTSI IRB Consortium (SEWIC)

Research projects must involve at least two of the following institutions:

o   Medical College of Wisconsin (MCW)

o   Children’s Hospital of Wisconsin (CHW)

o   University of Wisconsin at Milwaukee

o   Marquette University

o   Blood Research Center *As of 05/01/2014 MCW/FH IRB will review all new BCW-engaged projects

o   Milwaukee School Of Engineering (MSOE)

Submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office for studies involving any of the above institutions.

Although part of this consortium, Zablocki Veterans Administration (VA) does not defer review or serve as the IRB of Record for other IRBs at this time.

  • Wisconsin IRB Consortium(WIC)

Research projects must involve at least two of the following:

o   Medical College of Wisconsin

o   University of Wisconsin at Madison

o   Marshfield Clinic

o   Aurora Healthcare, Inc.

See WIC Share for instructions and forms for submitting a request to WIC.
 

  • Studies involving adults and minors

MCW and CHW have signed an Agreement that allows the MCW/FH IRB to serve as the IRB of Record for some studies involving adults and minors. For studies meeting the following criteria, submit the Coordinated IRB Review Request Form to the MCW/FH IRB Office:

o   Studies conducted at MCW/FH involving adults and minors

o   Studies conducted at MCW/FH and CHW involving adults and minors.

Requesting a Single IRB Review Not Involving Institutions Listed Above

The MCW/FH IRB is willing to consider a coordinated IRB review with another institution that is not within the SEWIC or WIC groups. The investigator is encouraged to contact the MCW/FH IRB Office or submit a Coordinated IRB Review Request Form to the MCW/FH IRB Office.

Investigator Responsibilities When Conducting a Multi-Site Study Using the Deferral Mechanism

  • If an IRB has determined that a single IRB review is appropriate, the PI will be notified which IRB will serve as the IRB of Record.
     
  • An IRB application must be submitted to the IRB of Record using their submission forms and process.
     
  • Investigators conducting research at MCW must follow all MCW corporate policies and MCW HRPP policies including the IRB SOP: Institutional Authorization Agreements & Other Review Mechanisms for Multi-Center Studies.
     
  • Investigators conducting research at FH must follow all FH corporate policies.
     
  • Unanticipated problems involving risks to subjects or others (UPIRSOs) must be reported to the IRB of Record and the MCW/FH IRB according to the IRB SOP: Requirements for Reporting to the IRB. (should link to the policy page)
     
  • The MCW investigator is responsible for assuring that institutional requirements are met in regard to human subject protections training, Safety Committee reviews, OCRICC review (FH Office of Clinical Research and Innovative Care Compliance) and any other MCW or FH institutional requirement.
     
  • If the IRB of Record is not MCW/FH IRB, initial and continuing review IRB approval letters from the IRB of Record must be provided to the MCW/FH IRB Office. Institutional and IRB policies of the IRB of Record must be followed.
 Blood Center Projects

BloodCenter of Wisconsin has contracted with the Medical College of Wisconsin (MCW) for IRB services. This move was made to provide access to greater IRB resources in terms of regulatory compliance and expertise, IRB staffing and services, and electronic protocol management. This change is intended to help meet the growing needs of BloodCenter researchers.

 Projects Deferred to NCI-CIRB

Projects Deferred to NCI-CIRB

Per 45 CFR 46.114, an institution participating in a cooperative project may enter into a joint review arrangement in an effort to avoid duplication of effort. To this end, MCW has entered into an Agreement with NCI CIRB that allows NCI CIRB to provide IRB review and oversight for cooperative group projects.

IRB SOP: Projects Deferred to National Cancer Institute Central IRB outlines the process for MCW faculty who wish to conduct NCI CIRB approved protocols with NCI CIRB as the IRB of record. Appropriate information must be submitted to the MCW/FH IRB Office for deferral notification.

These projects will still be required to use the appropriate MCW ICF Template: A-NCI to ensure local requirements and HIPAA authorizations are incorporated.

Information and work guides are available to assist teams in entering these projects into eBridge. These documents have been developed by eBridge Support in collaboration with the MCW/FH IRB Office. 

Finally Investigators will be required to inform the Institution or MCW/FH IRB Office (via eBridge) in addition to NCI-CIRB of the following changes or events which may occur during the conduct of the project:

  • Change of PI 
  • Study staff changes
  • Protocol changes which require additional Safety Committee review
  • Internal UPIRSOs that are not also AEs or SAEs, for example stolen laptop, security breach
  • Internal events that CIRB determines are UPIRSOs
  • Internal potential serious or continuing noncompliance
  • Internal subject complaints
  • All audit reports from the MCW/FH site, including those from CIRB, cooperative groups, or the FDA
  • Study Closure

 

 Research using data or specimens from deceased individuals

Decedent Research

Research protocols involving all decedents do not require IRB review & approval as it is not considered human subjects research.  However, based upon federal regulations for HIPAA at 45 CFR 46.160 and 164, a review by the Institution's Privacy Board is required.

MCW/FH IRBs also serve as the Privacy Boards. Principal investigators conducting research with decedents must submit an eBridge SmartForm application to the IRB for review and determination prior to conducting their research.

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Page Updated 12/03/2014
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