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Financial Conflicts of Interest in Research


Introduction

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

  • The Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F)
  • Responsible Prospective Contractors (45 CFR Part 94). 

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.

The Medical College of Wisconsin’s (MCW) 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.

Federal Regulations

The two revised Codes of Federal Regulation (CFR), published in the Federal Register/Volume 76, No 165 on August 25, 2011, can be found in their entirety via the hyperlinks provided here:

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

MCW Corporate Policy RS.GN.020

The Medical College of Wisconsin (MCW) has 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.  The Corporate Policy was written to meet the requirements of the regulation.

MCW Significant Financial Interest (SFI) Process

One of the most significant changes to the revised regulations relates to what information must be disclosed by Covered Persons and when. 

  • Prior Regulation - Per the previous 1995 regulation, an investigator or key personnel was asked to report, at the time of application to a PHS funding agency, any financial Conflicts of Interest that they had that could affect or bias the outcomes of the research project for which funding was being sought. 
  • New Regulation  - The current regulation requires an investigator or key personnel (Covered Person as defined in MCW’s Corporate Policy) to disclose to MCW any Significant Financial Interests (SFIs) equaling $5,000 or more that could reasonably appear to be related to that persons professional responsibilities at the Medical College of Wisconsin.  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 PHS funded grant, cooperative agreement or contract application OR is named as a ‘key personnel’ 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.

The MCW Financial Conflicts of Interest in Research Committee will determine if any of these SFIs could reasonably be considered to be a conflict of interest with PHS funded research activities that the Covered Person is participating in.

Instructions for completing and uploading the Description of SFI Form can be found at SFI Process/Instructions (pdf).  This web page also contains the link to the 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 MCW PHS funded research,
  • 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:

Sandi J Stoflet, Corporate Compliance Office (stoflet@mcw.edu)

Jane Rebro, Corporate Compliance Office (jrebro@mcw.edu)

 

Instructions to Complete Training

  1. Log into eBridgeMCW http://ebridge.mcw.edu.
    1. Note:  If you do not currently have an eBridgeMCW account, please Register.  When your registration is complete, the eBridgeMCW Help Desk will email your eBridge ID and Password information to you.
  2. Select My Home from the upper right corner of the screen.
  3. Select the Study Staff or Proposal Team home page from the left column.
  4. Select My Researcher Profile link from the top middle of your Personal Workspace (My Home).
  5. In the Researcher Profile Workspace, select the Financial Conflicts of Interest in Research Training activity from the left column of the screen.
  6. This link opens the training. eBridge will remain open in the window behind the presentation.
  7. NoteAdobe Flash Player is required to view the FCOI-R training module.  If you encounter problems or do not currently have Adobe Flash Player, please download the latest version of the Flash Player to your PC or MAC from the Adobe website, http://get.adobe.com/flashplayer/.  
  8. 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.
  9. Complete the Assessment and Attestation. 

 

Confirm 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 eBridgeMCW http://ebridge.mcw.edu.
  2. Select either the Study Staff or Proposal Team home page from your My Home.
  3. Within the summary panel space of your Personal Workspace, select My Researcher Profile.
  4. Select the Compliance Training tab to view your completed compliance training records which includes completion date as well as expiration date.


If you have questions about eBridge or have technical questions on the Adobe Flash Player, please contact the MCW Help Desk at help-ebridge@mcw.edu (414-955-8476), or complete an eBridge Help Desk Service Request.  If you have questions about the regulation or completion of this training, please contact Sandi Stoflet (Research Compliance Office) at Stoflet@mcw.edu.

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Page Updated 07/08/2014