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 are Research Involving Human Subjects (PDF)
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.
Frequently Asked Questions
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 Froedtert Menomonee Falls Hospital and Froedtert West Bend 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 Versiti Blood Center 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 Wisconsin IRB has its own, different rules about who may serve as a Principal Investigator.
- Clement J. Zablocki VA Medical Center has its own, different rules about who may serve as a Principal Investigator.
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.
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 FAQs 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).
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.
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. Additional information is also available at the Human Research Approval section of the Research Concierge website.
- 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:
- Institutional Biosafety Committee
- Hazardous Chemical Safety Committee
- Radiation Safety Committee
- MRI Safety Committee
- 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 Hospital 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.
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 Froedtert Menomonee Falls Hospital and Froedtert West Bend Hospital.
Children's IRB Review
Research projects which involve Children's patients (records or direct contact/intervention/treatment) or only Children's employees should be submitted to the Children's IRB for review and approval. In the following circumstances involving both Children's and MCW/FH, the Coordinated IRB Review Request Form can be completed and submitted to the Children's 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 Children's and MCW/FH medical records
- If the research project involves minors in the Southeastern Wisconsin community
- If the research project involves Children's and MCW/FH employees
- Versiti 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.
Visit the HRPP Investigators and Study Staff page to view the section on Coordinated IRB Review for details.
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 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.
Examples of events which may generate "For Cause" audits and an overview of the process, including determination of the need for an audit.
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.
- Collaborative IRB Training Initiative (CITI) certification is required
- Department of Defense (DOD) training is required if funded by DOD
- Research Bank training is required if using banks
See Human Research Protection Program Training for full details.
Optional training includes the following, also outlined on the HRPP Training page:
Human Research Series, Modules A, B and C
The HRPP Office presents a series of optional interactive sessions throughout the year. 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 12:00 pm-1:00 pm. The meetings are generally held on the third Tuesday of every month, from 12:00 pm-1:00 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 Personalized Training - Human Research Projects
Research Systems Training offers introductory eBridge training sessions for Principal Investigators and Research Staff involved in human subject research. The classes are scheduled on an as-needed basis in your workspace, if possible. The 1 hour session focuses on how to create and edit a Study/Project, AME, CPR, and RE. Register here Please Note: The eBridge Navigation (Online) course is a prerequisite for the session.
- MCW/FH IRB SOPs
- MCW Corporate Policies on Human Subject Research (contact the Office of Research for more information)
- Good Clinical Practice: FDA-regulated clinical trials of drugs, devices & biologics
- Using medical records and HIPAA Privacy Rule
Questions regarding institutional policies relating to human subject research or an IRB submission and review should be directed to the HRPP Office, (414) 955-8422.