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...

 

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

 Multi-Site Projects

Multi-site Projects

Is my project considered “multi-site”?

MCW considers a multi-site project to be a human subjects research study that will be initiated at more than one location other than or in addition to MCW. This definition includes community-based projects as well as clinical trials. Examples include:

  1. MCW and Children’s Hospital
  2. Froedtert Hospital and Marquette
  3. MCW and United Community Center
  4. Clinical trial conducted at numerous sites, even if all sites obtain IRB approval independently of each other

If you are uncertain if your project is considered “multi-site”, contact the MCW HRPP Office for guidance at IRBOffice@mcw.edu.

What is “engaged in Human Subject Research”?:

An institution becomes "engaged" in human subjects research when its employees or agents (all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility)

  1. intervene or interact with living individuals for research purposes;
  2. obtain individually identifiable private information for research purposes,
  3. obtain informed consent from human subjects; or
  4. receive HHS funds even when all activities are carried out at another institution or by employees of another institution.

If MCW is engaged in human subjects research, then IRB review of some type will be required.

The MCW/FH IRB or IRB Chair (or designee) will make the final determination regarding engagement in human subjects research as described in the IRB SOP: Determining Human Subject Research.

Oversight and jurisdiction of the MCW/FH IRB:

All research studies meeting the following criteria must be submitted to the MCW/FH IRB for review and approval.

  • Human subject research activities conducted at MCW.
  • Human subject research activities conducted or initiated by MCW employees or agents at any other site.
  • Human subject research activities that make use of any MCW resources other than faculty or employee time commitment.

Froedtert Hospital and the BloodCenter of Wisconsin have assigned the IRB review and approval of Froedtert Hospital and BloodCenter of Wisconsin human subjects research to the MCW/FH IRB.

Can MCW investigators use a different IRB?

If an investigator wishes MCW to rely upon a non-MCW IRB for review and approval of a study, the investigator must first submit a request to the MCW HRPP Office. Reliance request forms completed by investigators are used to make a decision about relying upon another IRB for review and oversight of a study that would otherwise be submitted to the MCW/FH IRB. Therefore it’s important that the forms are completed entirely to allow the MCW HRPP Office to make a decision.

See the procedures outlined below and in the IRB SOP: Reliance Agreements for Multi-site Projects for information regarding which forms to complete and where they should be submitted.

Questions regarding MCW/FH IRB oversight jurisdiction should come to the MCW HRPP Office.

IRB Review of Multi-site Projects

For multi-site studies, the IRB must review information about what research activities will be conducted on this campus and information about the entire project in order to understand how the MCW/FH/BCW investigators’ activities fit within the entire project.

What do I need to include in my IRB application for a multi-site study?

The breadth of information needed by the IRB is dependent upon the investigator’s role and will increase as the investigator’s responsibilities to the entire project increase. If the investigator is the PI for the entire study, the scope of review will include the MCW campus site and MCW/FH/BCW study team activities; every sucontracted or component site and that site’s study staff; and the leadership, management, communication, and safety monitoring plans for the integrated whole. Regardless of the investigator role, the IRB application must list one coordinating site or one lead investigator.

For a complete list of information needed for the IRB application, see the IRB SOP: Multi-site Projects and PI Responsibilities.

Reliance Agreements

The IRB is interested in making the IRB review process more efficient whenever possible. To that end, the MCW/FH IRB has developed a robust reliance system which includes policies and procedures through which certain types of studies may be eligible for review by a single IRB. Investigators must follow the established procedures in order to assure the effectiveness of the reliance system that has been developed. See the IRB SOP: Reliance Agreements for Multi-site Studies for more in-depth information.

How does the reliance system work?

  1. The study team completes the appropriate reliance request form & submits to the MCW HRPP Office.
  2. The MCW HRPP Office reviews the form. If the form is incomplete, the form will be returned.
  3. The MCW HRPP Office will review the information and decide if the request will be considered.
  4. If the request will be considered, the other IRB(s) will be notified and the request will be sent to them for review.
  5. The HRPP Office and involved IRBs will make a decision about whether reliance is possible and which IRB should review the study.
  6. The study team is notified of the decision and next steps.

NOTE:

  • A reliance decision cannot be made by investigators. It must be made by the MCW HRPP Office per policies and procedures.
  • If an IRB Agreement is not already in place, an Agreement needs to be negotiated and fully signed before reliance can be finalized.

How do I use the reliance system?

  1. For studies involving member institutions in SEWIC, WIC, MARCH and GPC, see information below.
  2. For all other studies, the investigator should complete the form Investigator Reliance Request Form and send the form and a protocol to the MCW HRPP Office.

All forms must be completed fully. If there is missing information, the form will be sent back to be completed.

IRB Consortiums involving MCW:

SEWICWIC Limited! MARCHLimited! GPC

MCW
FH
CHW
BCW
UW-MKE
MSOE
Marquette
VA

MCW
UW-Madison
Aurora
Marshfield
MCW
Indiana U
Mayo Clinic
Ohio State U
Univ of MN
UW-Madison
MCW
Children’s Mercy Hospital
U of Kansas
U of Nebraska
U of Texas SW Med Center
U of Iowa
Marshfield Clinic
U of MN
U of Texas Hlth Sc Cntr SA
UW-Madison

Southeast Wisconsin IRB Consortium (SEWIC)

Wisconsin IRB Consortium (WIC)

  • Can be used for most studies involving member institutions.
  • See WIC website for instructions and forms.
  • Forms must be completed and sent to the MCW HRPP Office along with a copy of the protocol and consent forms (if applicable).

Greater Plains Consortium of IRBs (GPC)

  • At this time, cannot be used unless the project has been designated as a GPC study.
  • Contact Connie Byrne in the MCW HRPP Office to discuss proposed projects.

Midwest Area Research Consortium for Health (MARCH)

  • At this time, cannot be used unless the project has been designated as a MARCH study.
  • Contact Connie Byrne in the MCW HRPP Office to discuss proposed projects.

After Reliance Decision is Made:

What do I do if MCW decides to rely upon another IRB?
  1. There should already be a well-established and working communication pathway with the collaborating investigators at other institutions before the request is made. This will facilitate questions such as what the MCW/FH/BCW investigator needs to provide to the reviewing IRB, what consent form should be used, where to find the IRB approval letter, etc.
  2. The consent form approved by the reviewing IRB will typically be used. This should be provided with the reliance request form to the MCW HRPP Office so that the form can be reviewed and any necessary changes to reflect local context can be requested.
  3. The consent form must be reviewed and approved by the reviewing IRB before enrolling subjects at this site.
  4. Institutional policies at MCW/FH/BCW continue to apply, including OCRICC review and approval, Safety Committee review and approval, human subjects protection training, and conflict of interest.
  5. UPIRSOs, serious and continuing non-compliance, suspension/terminations and subject complaints should be reported to the reviewing IRB per their policies AND the MCW HRPP Office per MCW/FH IRB policy.
What do I do if MCW agrees to serve as the reviewing IRB?
  1. The MCW/FH/BCW PI will complete the eBridge IRB application as described in the IRB SOP: Multi-center Projects.
  2. Typically the PI must be an MCW faculty member. See the IRB SOP: Requirements and Qualifications to Serve as a PI for exceptions from this requirement.
  3. The consent form approved by the MCW/FH IRB will typically be used. The consent form should be provided to the other sites. Changes will be allowed in limited sections to allow for local language. The consent form for each site must be reviewed and approved by the MCW/FH IRB before enrolling subjects at that site.
 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 04/09/2015
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