Financial Conflict of Interest in Research
A financial conflict of interest (FCOI) occurs when an investigator has a financial interest that may compromise, or have the appearance of compromising, professional judgment in the design, conduct, or reporting of research. FCOIs are neither new to research nor inherently negative. Furthermore, the current landscape has been revolutionised by a recent change in thinking about intellectual property (IP) and financial interests. Many funding agencies, including public ones, now encourage and sometimes even mandate protection and commercialisation of researchers’ ideas and findings to attract additional investors (biotechnology firms, pharmaceutical industry, venture capitalists, etc.) to further research and develop the results for the benefit of the public. OSR as most large institutions, has an Office of Biotechnology Transfer, which directly handles these issues and advises researchers on intellectual property. The fact remains however, that when there is a potential for financial gain, it is imperative that the public, legislators, the judiciary, and the scientific community at large are convinced that results were not biased for personal gain.
On the other hand, while FCOIs might be perceived to be more serious than other COIs, they are possibly less complicated to recognise, can be measured and are usually highly regulated. It is therefore important to understand how FCOIs can affect a project, grant application and/or scholarly publication and how they should be reported and managed.
The Ospedale San Raffaele Financial Conflict of Interest Policy is effective since April 19, 2016 and it is consistent with the requirements of the 2011 Public Health Service (PHS) revised Financial Conflicts of Interest (FCOI) regulations (42 C.F.R. Part 50).
Conflict of Interest in research may occur when outside financial interests compromise, or have the appearance of compromising, the professional judgment of a researcher when designing, conducting or reporting research.
In this page you can find FCOI-related compliance forms, resources, training materials, and other information related to financial conflict of interest that will be of interest to the Ospedale San Raffaele research community.
FCOI Training for grant applications
If you are planning to submit a grant application to the Public Health Service (PHS) or to other extramural funding of international, private or public Funding Agencies adopting U.S. PHS regulation on Financial Conflict of Interest, you must complete FCOI training:
POLICy documents & FORMs
- Financial Conflict Of Interest Policy |download
- Investigator Financial Interests Disclosure Form (for internal PIs and Sub-recipients) |download
- Project /Contract Form |download
- Sub-Recipient Financial Conflict of Interests Agreement |download
FCOI Flow Chart
- Part A PRE-AWARD /INITIAL FINANCIAL INTEREST DISCLOSURE |download
- Part B POST-AWARD_ FINANCIAL INTEREST DISCLOSURE |download
- Part C REPORTING to PHS/SPONSOR IN CASE OF FCOI |download
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OSR fully adheres to the requirements set forth in the US PHS revised Financial Conflicts of Interest regulations (42 C.F.R. Part 50) for all research grant applications to US government agencies funded by the US Public Health Service (PHS) or other funding agencies specifically requiring the adoption of said regulations. Compliance forms, resources, training materials, and other related information are available on OSR institutional web pages.
For all other funding agencies, OSR investigators must disclose relevant financial interests to funders of research as required by them. When there is no explicit request for disclosure of relevant financial interests, OSR investigators are nevertheless encouraged to contact the RIO to discuss whether a potential FCOI should be ascertained and disclosed to the funding agency.
Scholarly journals and their publishers, including scientific societies, provide guidance and/or mandatory indications on the management of FCOIs (James and Horton, 2018). OSR investigators must rigorously adhere to the provided indications and fully disclose the required information.
When there is no explicit request for disclosure of relevant financial interests, OSR investigators are nevertheless encouraged to contact the RIO to discuss whether a potential FCOI should be ascertained and disclosed to the publisher.
OSR investigators are expected to communicate relevant financial interests when making an appearance, either in person or in writing, before any public body, commission, group, or individual, to present findings or to give an opinion with respect to any issue or matter up for consideration, discussion, or action, and even when not explicitly requested.