Principal Investigator Eligibility at the Medical College of Wisconsin

A Principal Investigator, or PI, has overall responsibility for the conduct of a research project.

Criteria for Principal Investigators

MCW currently recognizes the following classes of individuals to be eligible to serve as a Principal Investigator at MCW. Residents and fellows may not serve as Principal Investigators on projects.

all

MCW Faculty Paid

Pursuant to the rules of the Faculty Handbook, 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.

MCW Faculty Unpaid

Pursuant to the rules of the Faculty Handbook, 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).

Blood Center of Wisconsin Investigators

This designation was specifically created for individuals from Versiti Blood Center of Wisconsin who are not MCW faculty, but for whom BCW has determined can provide value in conducting research at BCW.

Individuals in this category must be Blood Center staff with a Master’s degree or higher.

Fellows may not be the PI on research projects. They may be co-Investigators collaborating with an eligible PI as identified per this policy.

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 Froedtert Hospital has determined can provide value in conducting research on the MCW, Froedtert Hospital or Versiti Blood Center of Wisconsin campus.

Individuals in this category must receive designation from the Froedtert Nursing Research Council, a PhD nurse researcher, and the Chief Nursing Officer.

Froedtert Hospital Pharmacists

This designation was specifically created for individuals with a pharmacist degree who do not meet the eligibility criteria to become faculty at MCW, but whom Froedtert Hospital has determined can provide value in conducting research on the MCW, Froedtert Hospital or Versiti campus.

Individuals in this category must receive designation from the Froedtert Pharmacy Research and Professional Development Committee.

Froedtert West Bend Hospital Physicians

This designation was specifically created for individuals from Froedtert West Bend Hospital who are not MCW faculty, but whom Froedtert Hospital has determined can provide value in conducting research at Froedtert West Bend Hospital.

Individuals in this category must be a physician, hold a medical appointment at Froedtert West Bend Hospital, and receive designation from Froedtert Hospital Corporate Compliance.

Froedtert Menomonee Falls Hospital

This designation was specifically created for individuals from Froedtert Menomonee Falls Hospital in Menomonee Falls who are not MCW faculty, but for whom Froedtert Hospital has determined can provide value in conducting research at Froedtert Menomonee Falls Hospital.

Individuals in this category must be a physician, hold a medical appointment at Froedtert Menomonee Falls Hospital, and receive special designation from Froedtert Hospital Corporate Compliance.

CTSI Scientist or 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.

Who Can Serve As A Principal Investigator

MCW defines an Investigator as any individual who:

Leads or directs a research project involving human subjects
Performs activities that engage MCW, Froedtert Hospital or Versiti in anyone else’s research project
Uses MCW, Froedtert Hospital or Versiti resources; including lab equipment, physical space, or services
Brings research data onto the campus (MCW, Froedtert Hospital or Versiti space)
Performs any research activity on MCW, Froedtert Hospital or Versiti 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.

PI Education & Training Requirements

All MCW/Froedtert Hospital Investigators must complete required training prior to submission of a research project for review and approval to the MCW/Froedtert Hospital IRB. Investigators are required to remain up-to-date with required training to continue to conduct research at MCW/Froedtert Hospital.

The following training is required for Principal Investigators:

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/Froedtert Hospital IRBs or another authorized IRB must obtain CITI certification. CITI certification is obtained by completing the required online 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.

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.

Shipping Infectious Materials
Required for anyone shipping infectious materials, blood, lab samples, dry ice, etc.

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

For additional eligibility requirements, review the IRB SOP: Requirements & Qualifications to Serve as a Principal Investigator