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.
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 (firstname.lastname@example.org)
Jane Rebro, Corporate Compliance Office (email@example.com)