Working with Human Subjects


Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with information about humans is considered to be human subject research and requires review.

Additional information on when human subject review is required is described in IRB SOP: Determining when Activities and Research Involves Human Subjects

The MCW/FH Institutional Review Board (MCW/FH IRB) reviews human subject research to ensure the ethical and equitable treatment of those subjects under federal and state laws. The MCW/FH IRB is part of the Human Research Protection Program (HRPP) in the Office of Research at MCW and is federally registered with OHRP & FDA.

 Who is eligible to be a Principal Investigator (PI) for human subjects research?

In general, only persons with MCW faculty appointments may serve as Principal Investigators. Students, residents and fellows generally are not allowed PI status -- students, residents, and fellows must recruit an MCW faculty member to serve as Principal Investigator for IRB purposes.

There are exceptions:

  • Froedtert Hospital has a system for recognizing qualified Froedtert Nurses and Pharmacists as Principal Investigators.
  • Staff at Community Memorial Hospital and St. Joseph's Hospital who do not have MCW faculty appointments are generally eligible to serve as Principal Investigators, unless they are students, residents, or fellows.
  • Staff at the BloodCenter of Wisconsin who do not have MCW faculty appointments will be generally eligible to serve as Principal Investigators, unless they are students, residents, or fellows.
  • Children’s Hospital of Wisconsin IRB has its own, different rules about who may serve as a Principal Investigator.
  • Zablocki VA Medical Center has its own, different rules about who may serve as a Principal Investigator.
 What approvals do I need?

All human subject research activities must be submitted for review and approval by the Institutional Review Board (IRB) by creating a SmartForm application (PRO) in eBridge. eBridge, our web-based system for research submissions, is accessible anywhere and at any time. The PRO must be approved prior to initiating the human subject research activities it describes. For full details, visit eBridge Training - Human Submissions on the eBridge Support web site.

If the human subject research activities incorporate animal material, please note that application and approval from the Institutional Animal Care and Use Committee (IACUC) may be required.  For information on obtaining approvals for animal research, visit Research Resources Working with Animals.

If the human subject research activities incorporate potentially hazardous agents, biological hazards, radiation and/or radioactive materials, or hazardous equipment (e.g. MRI), approval may be required by one or more of the safety subcommittees.  For information on obtaining approvals for hazardous material, visit Research Resources Obtaining Approvals and select the appropriate category for your needs.

If the human subject research activities propose to use the Translational Research Units (TRU), approval is required from the TRU.

If the human subject research activities propose to use, conduct or access resources in Froedtert Hospital, an application must be submitted to the Office of Clinical Research and Innovative Care Compliance (OCRICC).

 

What do I submit first?


These applications can be submitted at the same time to the various committee(s) for review. However, it is important to note that the IRB cannot render a final decision until all ancillary committee decisions are confirmed. 

 How long can I expect the approval process to take?

Approval times provided below reflect the median number of days for submissions during calendar year 2013.

Full committee reviews – initial submission (n=118)

  • From IRB receipt to first meeting: 32 days
     
  • From first meeting to approval: 26.5 days
     
  • From IRB receipt to approval: 75 days
     
  • 70% of the human research projects that underwent full committee review were approved at the first meeting (this includes projects that were granted full approval at the initial meeting and approval pending modifications).
     
  • 23% of the human research projects that underwent full committee review were approved at the second meeting (studies were tabled required review at 2nd meeting and were then granted full approval at the 2nd meeting or approval pending modifications).

Full committee reviews – continuing progress reports (n=328)

  • From IRB receipt to approval: 37 days

Expedited reviews – initial submission (n=350)

  • From submission to approval: 35 days
     
  • From submission to exemption: 38 days

Expedited reviews – continuing progress reports (n=1211)

  • From IRB receipt to approval: 13 days
 What can I do to streamline the approval process?

The Institutional Review Board (IRB) and Human Research Protection Program (HRPP) office will work to facilitate a smooth review process for both new and existing Investigators.   Please submit the eBridge PRO SmartForm (PRO) and other applications which apply to your research at your earliest convenience.  In addition, Research Resources Starting Up Research offers additional guidance.

  • Consultation with the HRPP office or HRPP Director
    • If an Investigator is new to MCW and bringing research data or specimens to MCW, a consultation is recommended to identify the best pathways to transfer the research to MCW.  For current Investigators, the HRPP is always available to discuss new projects or changes to currently approved projects to identify and work through any possible IRB concerns.
  • Initiate the PRO SmartForm (PRO) in eBridge
  • Complete the applicable form(s) for Safety Committee Review and approval:
    • Subcommittees of the Joint Safety Committee are: Institutional Biosafety Committee; HazChem Safety Committee; Radiation Safety Committee; MRI Safety Committee.

    • Safety subcommittee applications are available on the MCW intranet site. If you have access to InfoScope, search for keywords “safety committee forms.”
  • Contact your department administrator to begin the process of transferring any possible grant funds to allow you to pay for any possible costs incurred.

  • Contact and work with Froedtert Hospital’s Office of Research Innovation Care and Compliance (OCRICC) if you will be enrolling subjects at Froedtert or using Froedtert Hosptial resources (including records).

  • Complete the required CITI Human Subjects Training or affiliate to MCW to access your previous CITI training and complete the additional required MCW modules.
 Which IRB has jurisdiction for my study?

The Milwaukee Regional Medical Center has many institutions on the campus including the Medical College of Wisconsin.  Many of these institutions  have separate Institutional Review Boards (IRBs) to review the research which may be occurring under their faculty, in their buildings, or with their patients. MCW Faculty are required to submit their research projects to the MCW/FH IRB. There are exceptions to this policy because of agreements with many of the institutions on the campus to help facilitate a streamlined review process when possible.  If the research involves multiple institutions, investigators should complete the Coordinated IRB Review Request Form prior to submitting to an IRB to see if a single IRB review is possible and which IRB will provide that review.

MCW/FH IRB Review

Froedtert Hospital has established an agreement with the Medical College of Wisconsin to handle all IRB review of research projects conducted in any of their facilities or involving their employees or patients. Froedtert Hospital’s agreement also includes research being done at Community Memorial Hospital in Menomonee Falls and St. Joseph’s Hospital in West Bend.

CHW IRB Review

Research projects which involve CHW patients (records or direct contact/intervention/treatment) or only CHW employees should be submitted to the CHW IRB for review and approval. In the following circumstances involving both CHW and MCW/FH, the Coordinated IRB Review Request Form can be completed and submitted to the CHW or the MCW/FH IRB Office to decide whether or not a single IRB review is possible and which IRB will provide that review:

  • If the research project involves review of CHW and MCW/FH medical records
  • If the research project involves minors in the Southeastern Wisconsin community
  • If the research project involves CHW and MCW/FH employees

Blood Center of Wisconsin (BCW) IRB Review

Research projects which involve BCW donors, facilities, or records should submit their applications to the BCW IRB for review and approval. If the project also involves MCW or FH, the Coordinated IRB Review Request Form can be completed and submitted to the BCW IRB Office.

Zablocki VA IRB Review

Research projects which seek to recruit, and involve veterans (records, or direct contact/intervention/treatment) must contact the Zablocki VA and submit their research to the VA IRB for review and approval.

 How do I request a single IRB review for research at multiple institutions?

Visit the HRPP web page Coordinated IRB Review for details.

 Is auditing or monitoring required?

After the Institutional Review Board (IRB) has approved a SmartForm Application (PRO), the IRB has the responsibility to ensure that procedures are carried out as described in the PRO. The IRB utilizes the Quality Improvement team (QI) for monitoring research activities following approval. These include the following:

  • Routine Reviews
    Routine reviews are a mechanism for the MCW Human Research Protection Program (HRPP) to provide internal oversight of the conduct of human research studies that are reviewed and approved by the MCW/FH IRBs.
     
  • For-Cause Audits
    Examples of events which may generate "For Cause" audits and an overview of the process, including determination of the need for an audit.
 I am interested in conducting a clinical trial. What steps should I take?

The general steps involved with starting up a clinical trial are summarized here.  Note that the particular sequence of the steps may vary according to individual requirements, and some steps may occur concurrently.  Jump to any section by clicking on the arrow corresponding to the step you wish to learn more about.

If you wish to conduct clinical trials pertaining to cancer, please visit the Clinical Trials Office of MCW's Cancer Center for information on available services and support for interventional cancer trials.

If your clinical trial requires any resource (i.e. staff support, supplies, equipment, protected health information (PHI), etc.) from a Froedtert Health (FH) entity (e.g. Froedtert Hospital (FMLH), Community Memorial Hospital (CMH), St Joseph’s Hospital (SJH) or any FH Clinic), researchers must connect with the FH Office of Clinical Research Innovative Care Compliance (OCRICC) to facilitate collaboration with the FH Leader: email OCRICC or visit the SCOUT site.

 

Step 1. Identify Protocol


Protocols can come from various sources.  Investigators can develop or draft their own protocols or they can pursue the option of becoming a local PI on a regional, national, or global trial.  Pharmaceutical companies, Cooperative groups, and Clinical Trial Consortiums are all avenues by which clinical trials can be opened locally at MCW.

 

 

Step 2. Sign Confidentiality Agreement (CDA)


If you decide to open a trial through a Pharmaceutical company, you most likely will need to complete a Confidentiality Disclosure Agreement (CDA) before the sponsor will release the protocol document to you and your staff.  The CDA should always pass through the Office of Grants & Contracts (GCO) to ensure the language is appropriate for the investigator to sign; often, the language requires some level of editing before signature.

The Medical College of Wisconsin maintains a corporate policy Contract Requirements for Sponsored Human Research (RS.GC.040) which is available on the College’s intranet site.  If you have access to InfoScope, review this policy by searching for keywords “contract requirements” and select the link to this policy.

 

 

Step 3. Assess Feasibility


Before you can fully commit to a research project, feasibility must be assessed.  Determine the logistics needed within your own MCW department and others, such as Radiology, Cardiology, Dynacare, etc.  The following questions should be considered as part of the assessment process:

  • Does your department/clinic have the qualified staff, equipment, and time to run the trial?
     
  • Do you need/have a clinical research coordinator or assistant?
     
  • Do you have a qualified staff member to do the IRB submission?
     
  • Who will do the data entry and fill out the case report forms?
     
  • How will you recruit subjects?
     
  • Will Froedtert departments/resources be necessary for the trial?
    • Does your protocol require CT or MRI scans?
    • PET scans?
    • EKGs?
    • Blood Draws?
    • Drugs?
    • PHI?

Feasibility issues involving resources requested of FH departments must go through OCRICC.  Feasibility not assessed via OCRICC will not be honored by FH.  Sponsor surveys of any kind that address FH resources/equipment must be facilitated through OCRICC.

 

 

Step 4. Review with Departmental Committees/Groups


Departments often have their own committees that review clinical trials prior to making a final decision about opening them, such as a Scientific Review Committee, Faculty Disease Group, Data Safety Monitoring Board, etc.  Sometimes the review group consists of formally appointed members; other times the trial must simply be discussed among other physicians within the department.  Consult with your department Administrator or colleagues within your department to learn what steps to take for departmental review.

 

 

Step 5. Identify Funding


Sponsored clinical trials include funding.  However, if you are opening an investigator initiated trial, you will likely need funding to support the trial.  Therefore, it is important to assess the cost of running a trial and seek adequate funding.  We recommend visiting the Finding Funding section in Research Resources for current opportunities, links to funding agencies, and resources available to assist you in your search for funding.

 

 

 Step 6. Develop/Finalize Budget


Applications for funding are submitted via eBridge in the form of a Funding Proposal and routed through the Office of Grants & Contracts (GCO).  Your study will not be IRB approved until funding is awarded.  There are several sources of support to assist you with the submission process:

 

 

Step 7. Obtain Approvals


IRB

You must receive IRB approval prior to beginning any research activities. Your study may also require approval from ancillary committees, depending on the nature of the research to be conducted: e.g. Radiation Safety Committee, Institutional Biosafety Committee, MRI Safety Committee.

The approval process is conducted via eBridge, the College’s online mechanism for submitting protocols. Your department may have a designated person or persons who can assist you in completing the eBridge IRB application, known as a SmartForm.  Research Systems Training also has services for assisting you with your submission process.

We recommend reviewing What is eBridge? and Working with Human Subjects within the Obtaining Approvals section of Research Resources.  Within Obtaining Approvals you will also find information on how to obtain approval for Working with Radioactive Material, Working with MRIs, Working with Biologicals, etc.

 

OCRICC (Office of Clinical Research and Innovative Care Compliance)

Clinical trials that utilize any FH resources - staff, facilities, equipment, etc. - in one way or another, must be reviewed via OCRICC to ensure that FH has the staff, equipment, and other resources to successfully support the trial.  OCRICC facilitates collaboration with FH leaders for researchers to receive a commitment of these requests for the research.  Following notification of MCW/FH IRB Approval, OCRICC provides a FH Administrative Approval for your protocol before researchers can consent any patient.  Submitting your project’s OCRICC application at the same time as the IRB submission will facilitate the FH administrative approval, and will typically follow notification of MCW/FH IRB approval within an average of 3 business days.

 What are my additional responsibilities for clinical research?

Investigators should be aware of the following topics when starting, conducting or closing a clinical trial to ensure they are conducting the trial accordingly. These topics may or may not apply to every clinical trial being started or conducted and should be researched to see if they are applicable.

ClinicalTrials.Gov Registration

Good Clinical Practice (GCP)/ICH E.6 guidelines (pdf)

 What Training is Required?

MCW HRPP requires the completion of the online Collaborative IRB Training Initiative (CITI) program.    In 2004 MCW announced the requirement to all individuals involved in the design, conduct or review of human subjects research to have been certified under a new educational program.  If an Investigator has completed CITI modules at a previous institution, they are able to transfer that work within CITI by opting to change their institutional affiliation to MCW. See the FAQ below for more specific instructions.

Initial


Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must obtain CITI certification. CITI certification is obtained by completing the required on-line modules with an overall score of 80%. The initial CITI course can be completed in four to six hours. Six CME credits are available from CITI.

  • New employees must complete the required modules and obtain CITI certification within 90 days from date of hire.
  • An investigator may not be a Principal Investigator until initial certification is complete.

The required modules depend on the type of research and your role in that research.

  • Biomedical Research involves any type of clinical research studies, including those that involve investigational drugs and/or devices.
  • Social/Behavioral Research involves observational and survey research, work with population and/or epidemiological studies. This type of research does not involve any drugs or devices (investigational or marketed).
  • Please refer to the HRPP Certification Program web page - Requirements for help in determining the modules required for your role in a study.
     

Annual


Additional human subject protection education is required each year for investigators and coordinators.

  • MCW investigators and coordinators must obtain three hours of human subject protection education annually.
  • Non MCW members of the research team must obtain one hour of human subject protection education annually.

     

CITI Refresher


In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained. Completion of the refresher modules can usually be completed in less than two hours.

 

Frequently Asked Questions


For these and additional FAQs, and for comprehensive information on CITI certification, please visit the HRPP Certification Program web page

Who must complete requirements of the MCW Human Research Protections Certification Program?
Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW/FH IRBs or another authorized IRB must be certified.

Will my training that I completed at another institution be accepted?
If you are involved in human subject research at either Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and are current in your human subject protection training, MCW will accept this training.

If you have completed human subject protection training at an institution other than Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact _citihelpdesk@mcw.edu .

How long will it take to complete the certification program?
The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course. You may complete it multiple sittings. The certification program is web-based and can be accessed from any computer via the internet.

What are some available options for the required annual education/training?

  • Annual Research Conference
  • MCW program, clinical research workshop or seminar regarding human research
  • Human Research Professionals Meeting
  • CITI Core Course module not done for initial certification CITI Refresher Course module not required for biennial recertification
  • Clinical Research Scholars Program
  • Non-MCW sponsored courses regarding human subject research
  • NIH computer based training
 What resources and optional training are available?

 

Human Research Module Series

The HRPP Office presents a series of optional interactive sessions throughout the year entitled Human Research Module Series. The Module Series focuses on one or more features of human subject research at the Medical College of Wisconsin.

 

Core Education: Boot Camp

This educational event offered semi-annually to provide resources to the human research team member in the coordinator role that will expedite his/her ability to perform his/her job responsibilities in a manner consistent with federal requirements and guidance and other applicable policy.   The focus of this course is the very basic day to day functions of conducting research with an emphasis on providing practical information and tools that can be used immediately.

 

IRB Lunch & Learn

The meetings are generally held on the third Tuesday  month, from noon to 1 pm.  The meetings are generally held on the third Tuesday of every month, from noon to 1 pm in the MACC Fund building meeting room 3095. Several IRB staff members will be available on a walk-in basis to help you with the IRB review process. The first 20 minutes will be devoted to brief presentations on issues of general interest; the remaining 40 minutes is your time for questions and direct assistance.

 

Human Research Professional Monthly Meeting

This monthly program focuses on educating research faculty and staff on current research processes or new developments within MCW and Froedtert. The presentation is generally held on the last Tuesday of the month. Attendees are welcome to bring their lunch. A beverage and dessert are provided.

 

eBridge Classroom Training for Human Submissions

The Office of Research, Research Systems Training, offers introductory training sessions on the eBridge System for new users who are conducting human subject research at MCW/Froedtert.

The two-hour session focuses on four areas:

  • Navigating within the eBridge System.
  • Creating a new study using the Study SmartForm.
  • Making required change requests in the eBridge System.
  • Creating Amendments, Continuing Progress Reports & Reportable Events

Please Note: The Online Basic Navigation is a prerequisite for the in-class session.

 Policies, Procedures & Guidelines

 

MCW/FH IRB SOPs, Policies & Guidelines

Choosing this link will direct you to the HRPP web site which lists IRB policies & procedures. Use the back arrow to return to this site.

 

MCW Corporate & other policies related to human subjects research

Information on MCW Corporate Policies related to human subjects research as well as the MRI Safety SOP.

 

Good Clinical Practice: FDA-regulated clinical trials of drugs, devices & biologics

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects.

 

Using medical records and HIPAA Privacy Rule

Under the Privacy Rule, a researcher using or disclosing identifiable health information must (in addition to IRB and informed consent requirements) fulfill one of six allowable “HIPAA research pathways.”

 Whom do I contact if I have additional questions?

Questions regarding institutional policies relating to human subject research or an IRB submission and review should be directed to the IRB or the HRPP Office by email IRBOffice@mcw.edu or by phone 414-955-8422.

Contact HRPP

Phone: 414-955-8422

Fax: 414-955-6575

Email: IRBOffice@mcw.edu

Web: HRPP | QI

Location: MFRC 3040
MACC Fund Research Center

Office of Research
8701 Watertown Plank Road
Milwaukee, WI  53226-0509

 

Medical College of Wisconsin
8701 Watertown Plank Road
Milwaukee, WI 53226
414-955-8296
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