Research Collaborate Lab Hall

Financial Conflicts of Interest in Research

Training in FCOI-R and the reporting of conflicts may be required depending on your status. 

View instructions for FCOI-R Training in eBridge (PDF)

 

8/15/2021: Important update regarding FCOI-R Training

MCW Corporate Policy RS.GN.020 and Federal Regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) require that Financial Conflicts of Interest in Research training must be repeated “any time MCW revises this Policy or procedures in a manner that affects the Covered Person’s professional responsibilities at MCW.” 

Because MCW Corporate Policy RS.GN.020 Financial Conflicts of Interest in Research (FCOI-R) was revised on August 15, 2021,Covered Persons (Principal Investigators, co-Investigators, senior / key persons, and others who are responsible for the design, conduct or reporting of research) who are preparing funding proposals to a PHS agency (e.g. NIH, CDC, HRSA) or who are on a PHS sponsored research award will need to retake training at your earliest convenience after August 15, 2021.  Training MUST be retaken even if it has not yet been 4 years since the last time training was completed. 

If you have questions, or for more information, please contact the Research Compliance Office:

Matt Richter, Senior Manager of Research and Academic Compliance, mrichter@mcw.edu

Ellen Manning, Compliance Coordinator, elmanning@mcw.edu

John Atkisson, Compliance Coordinator, jatkisson@mcw.edu

 

Financial Conflicts of Interest in Research Policy


Introduction

The United States Department of Health and Human Services (DHHS) made significant revisions effective August 24, 2012 to two of its regulations regarding Financial Conflicts of Interest:

These regulations affect MCW when applying for or receiving PHS/National Institutes of Health (NIH) funding from a grant, cooperative agreement or contract.  These revisions were drafted to provide further assurance to the public that PHS funded research is conducted without bias and with the highest scientific and ethical standards.

Helpful and updated Frequently Asked Questions on the NIH Website can be found here:


MCW Corporate Policy RS.GN.020

MCW’s research collaboration with pharmaceutical firms, medical device companies and other entities is important to make certain that patients benefit from the translation of biomedical research into the clinical practice.  The rules require that MCW identify and where appropriate manage potential financial conflicts of interest that may arise from these collaborations to safeguard the protection of human research subjects as well as the integrity of MCW’s research effort.

MCW updated and posted its Corporate Policy on Financial Conflicts of Interest in Research on August 24, 2012 in order to meet all of the requirements of the regulations.  

In August, 2021, the MCW Financial Conflicts of Interest in Research corporate policy was revised to include investigators engaged in research sponsored by a Covered Award, which includes awards funded by a PHS entity, by any federal funding agency, by one of the select nonprofit sponsors that have adopted the federal FCOI-R regulations, and by an industry sponsor (Covered Award is defined in MCW Corporate Policy RS.GN.020).  In addition, the definition of a reportable financial interest was revised. Review a summary of these changes in the FCOI-R Policy Changes Summary (PDF).  


MCW Significant Financial Interest (SFI) Disclosure Process

  • MCW Corporate Policy RS.GN.020 requires an investigator or key personnel (Covered Person as defined in the policy) to disclose to MCW any Significant Financial Interests (SFIs) that could reasonably appear to be related to that persons professional responsibilities at the Medical College of Wisconsin (Significant Financial Interests are defined in the policy).  These SFI(s) must be disclosed by the Covered Person to MCW at the following intervals:
  • Each time a person is an investigator on a new proposal for a Covered Award OR is named as a ‘key person’ on such an award,
  • At least annually during the Medical College of Wisconsin’s Annual Conflicts of Interest and Outside Professional Activities process,
  • Within 30 days of a Covered Person discovering or acquiring any new SFI.

Significant Financial Interest Upload Instructions with Screenshots (PDF)

Significant Financial Interest Upload Instructions Condensed (PDF)

Description of SFI Form (XLSX)


MCW Required FCOI-R Training

Another significant change to the revised regulation requires all MCW Covered Persons to receive training on the rule and MCW policy.  Federal regulations (mirrored in the MCW Policy) require training for investigators/key personnel (MCW Covered Persons) at the following intervals:

  • Prior to engaging in any research study funded by a Covered Award,
  • Every four years thereafter,
  • Any time that MCW revises its policy,
  • If a Covered Person is new to MCW, or
  • If a Covered Person is found to be in non-compliance with MCW’s policy


MCW Financial Conflict of Interest in Research Contact Information

If you have questions about the FCOI-R Training or MCW Policy please feel free to contact the Research Compliance Office:

Matt Richter, Senior Manager of Research and Academic Compliance, mrichter@mcw.edu

Ellen Manning, Compliance Coordinator, elmanning@mcw.edu

John Atkisson, Compliance Coordinator, jatkisson@mcw.edu