Research Bench Lab

Financial Conflicts of Interest in Research (FCOI-R) Training

Training in FCOI-R may be required depending on your status

Training

To begin the training course, you should have an active eBridge account.

If you do not have an active eBridge account, please register here
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FCOI-R 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.

 

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

Instructions for Completing FCOI-R Training in eBridge
  1. Log into eBridge (Note: If you do not currently have an eBridge account, please register here. When your registration is complete, the eBridge Help Desk will email your eBridge ID and Password information to you.) 
  2. From your personal workspace (Dashboard), select View My Researcher Profile from the Activities column on the left side of the screen.
  3. In the Researcher Profile Workspace, select the Financial Conflicts of Interest in Research Training activity from the Activities column on the left side of the screen.
  4. This link opens the training (Section 1.0), assessment (Section 2.0) and attestation (Section 3.0). eBridge will remain open in the window behind the presentation.
  5. Upon completion of the training, either close the training window, or leave it open for review, and return to eBridge in the window behind it to complete the assessment and attestation.
  6. Complete the Assessment and Attestation.

Log into eBridge

Confirming Documentation of Completed Training

Once you have completed your training assessment and attestation, your compliance with the training requirement will be registered within your eBridge Researcher Profile. If you would like to confirm or view that the completion has been registered, please take the following steps.

  1.  Log into eBridge.
  2. From your personal workspace (Dashboard), select View My Researcher Profile from the Activities column on the left side of the screen.
  3. Select the Compliance Training tab to view your completed compliance training records which includes completion date as well as expiration date.

Log into eBridge