Who Can Submit Projects

For more information see IRB SOP: Requirements & Qualifications to Serve as a Principal Investigator

Definitions:

Human Subject – a living individual about whom an investigator (whether professional or student) conducting research obtains, data through intervention or interaction with the individual, or identifiable private information.

MCW/FH definition of Investigator

  • any individual who leads or directs a research project involving human subjects
  • any individual who performs activities that engage MCW/FH in anyone else’s research project
  • any individual that uses MCW/FH resources; including lab equipment, physical space, or services
  • any individual who brings research data onto the campus
  • any individual who performs any research activity on MCW/FH campus

A Principal Investigator has overall responsibility for the conduct of a research project, including all technical, programmatic, financial, compliance and administrative aspects. The Principal Investigator is responsible for controlling the technical direction and academic quality of the project, and will ensure that the project is carried out in compliance with the terms, conditions, and policies of the College and the Sponsor when applicable.

Office for Human Research Protections (OHRP) definition of Investigator - an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB.

For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subject research studies. Such involvement would include:

  • obtaining information about living individuals by intervening or interacting with them for research purposes;

  • obtaining identifiable private information about living individuals for research purposes;

  • obtaining the voluntary informed consent of individuals to be subjects in research; and

  • studying, interpreting, or analyzing identifiable private information or data for research purposes.

Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the “principal investigator” with overall responsibilities for the project. In every human subject research project, investigators have certain responsibilities regarding the ethical treatment of human subjects. (45 CFR 46)

FDA definition of Investigator – an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR 50.3 (d))

Principal Investigators
MCW currently recognizes four classes of individuals that are eligible to work as a Principal Investigator at MCW. Residents and fellows may not serve as Principal Investigators on projects. They may be co-Investigators collaborating with an eligible MCW faculty member.

  • Faculty Paid: Pursuant to the rules of the Faculty Handbook, which can be found on the Faculty Affairs website, individuals with a faculty appointment are eligible to serve as investigators at MCW. The individuals in this classification are employees of MCW. The coordination of their faculty appointment and research is handled through the academic department through which they are appointed.

  • Faculty Unpaid: Pursuant to the rules of the Faculty Handbook, which can be found on the Faculty Affairs website, individuals with an unpaid adjunct or voluntary clinical appointment are eligible to serve as investigators at MCW. However, because these individuals are not employees of MCW, there are some additional administrative steps which must be followed related to their appointment and research work at MCW. Individuals with this designation may receive their appointment and primary research support either through an academic department or through the Clinical & Translational Science Institute (“CTSI”).

  • CTSI Scientist or CTSI Senior Scientist: This designation was specifically created for individuals without a terminal degree who do not meet the eligibility criteria to become faculty at MCW, but whom MCW has determined can provide value in conducting research on our campus. Individuals in this category must receive their appointment through the CTSI office and seek administrative research support from them as well.

  • Froedtert Hospital Nurses: This designation was specifically created for individuals with a nursing degree who do not meet the eligibility criteria to become faculty at MCW, but whom MCW has determined can provide value in conducting research on the MCW/FH campus. Individuals in this category must receive designation from the Froedtert Nursing Research Council, a PhD nurse researcher, and the Chief Nursing Officer.

Questions regarding eligibility to conduct research studies involving human subjects should be directed to the MCW/FH HRPP Office.

Appointment review and approval process
There are three distinct review and approval processes, one for individuals receiving appointments through academic departments, one for those appointed through the CTSI, and a one for those appointed through the Froedtert Nursing Leadership Committee.

Institutional Human Subject Research Educational Requirements
All MCW/FH Investigators must complete required training prior to submission of a research project for review and approval to the MCW/FH IRB. Investigators are required to remain up-to-date with required training to continue to conduct research at MCW/FH.

The following training is required for Principal Investigators:

  1. MCW Certification Program, CITI

    • Initial - Everyone involved in the design, conduct, or review of human research carried out by MCW faculty, CTSI faculty and Froedtert nurses 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.

    • 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.

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

  2. Research Banks at MCW and Froedtert Hospital: IRB Training for Bank Personnel

    • Required for Bank Custodians who have access to the bank database, solicits subject consent for banking, or has record-keeping or administration responsibility for a bank.

  3. Shipping Infectious Materials

    • Required for anyone shipping infectious materials, blood, lab samples, dry ice, etc.

  4. For research supported by or required to follow a Department of Defense addendum:

    • For initial and continuing research, ethics education must be completed by all personnel who conduct, review, approve, oversee or manage human subject research. In support of this Investigators should complete MCW DoD human research module.

The following training opportunities are recommended but not required:

  • eBridge – Human Research Training
  • Human Subject Protections 2007
  • IRB Open House – Held monthly
  • Human Research Professionals Monthly Meeting
  • Human Research Orientation Series
  • Core Curriculum: Education for Human Research Team Members

Institutional Review Boards (IRBs)

  1. MCW faculty work at a variety of inter-related but separate institutions, and many of these institutions have their own IRBs. There are four distinct and separate Institutional IRBs which MCW faculty may encounter:

    • The MCW/Froedtert IRB for studies implemented in MCW space, Froedtert Hospital space, or away from campus (mostly studies of adult subjects);

    • The Children’s Hospital of Wisconsin IRB for studies implemented in CHW space (mostly studies of children and adolescents);

    • The Zablocki VA Medical Center IRB for studies implemented in ZVAMC space or which target veterans as subjects; and

    • The Blood Research Institute IRB for studies implemented in BRI space.

  2. The MCW/FH Human Research Protection Program (HRPP) office recommends that Investigators contact the IRB that has appropriate jurisdiction before preparing an application as each IRB has its own application process and policies.

  3. If the Investigator is aware of multiple institutions being involved with a project, they should contact the IRB to determine if multiple reviews can be avoided through the set up and execution of an Inter-institutional Authorization Agreement (IAA). For more information about multiple site studies and IAAs refer to IRB SOP: Institutional Authorization Agreements and Other Review Mechanisms for Multi-Center Studies.

  4. For more information about the different institutional IRBs, contact:

    • MCW/Froedtert IRB: Connie Byrne (955-8455)

    • Clinical Translational Science Institute (CTSI): Sara Goetz (955-2537)

    • Children’s Hospital of Wisconsin IRB: Lori Mrozek (266-2986)

    • Zablocki VA Medical Center IRB: Vicki Gollish (384-2000 ext 41435)

    • Blood Research Institute IRB: Marcia Iverson (937-6258)

Additional information can be found on the following web pages:

New Faculty Guide to Conducting Research at MCW

MCW HRPP Training & Educational Resources 
This includes information on the following offerings

  • MCW Certification Program and CITI training
  • Research Banks at MCW and FH: IRB Training for Bank Personnel
  • eBridge – Human Research Training
  • IRB Open Houses
  • Human Research Professionals Monthly Meeting
  • Human Research Orientation Series
  • Core Curriculum: Education for Human Research Team Members

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