Definition
A financial conflict of interest exists when the recipient's designated official(s) reasonably determines that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

Summary of Current Regulation
NIH requires recipient institutions and investigators to comply with the requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements. 

The requirements promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be free from bias resulting from any conflicting financial interest of an investigator.
Each Institution shall maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with the regulation and make the policy available via a publicly accessible Web site.

All researchers of the University Medical Centre Utrecht are asked to inform the Research Support Office when applying for NIH research funding.
By applying for or participating in NIH research funding activities, the University Medical Centre Utrecht (UMC Utrecht) , and on behalf of the institution each investigator involved, is subject to Public Health Services (PHS) regulation 42 CFR 50 Subpart F “Promoting objectivity in research”.
In this document we bring all related UMC Utrecht policies together, which inform all relevant parties of the rules and procedures to be followed, in case of Financial conflict of interest.

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Financial Conflict of Interest Policy related to NIH-funded research at the University Medical Centre Utrecht

In application of Regulation 42 CFR 50 Subpart F, the UMC Utrecht maintains a policy on Outside activities, as defined in the Article 9.3. of the collective labor agreement for university medical centres (CAO UMC) in the Netherlands.
The CAO UMC is formally a public-law employment status regulation. The terms of the CAO apply for all employees of the UMC Utrecht to the extent that they are employed by virtue of a letter of appointment or a contract of employment, unless otherwise agreed between the governing board and the unions in the LOAZ (National Consultative Committee of University Hospitals and the Unions).

In brief, every Investigator at UMC Utrecht, applying for or involved in NIH-funded research is subject to the Public Health Service’s (PHS) Financial Conflict of Interest (FCOI) regulation (42 CFR Part 50 Subpart F) and as an employee of UMC Utrecht abides to the regulations stated in the Article 9.3 on Outside activities, of the currently active formally agreed collective labor agreement for the university medical centres (CAO UMC) in the Netherlands. 

Within the given framework, he/she is will disclose his/her financial interests related directly to the NIH-funded project. This should be done using the form Register side jobs (direct link to intranet site of UMC Utrecht), provided in the Personnel portal of the UMC Utrecht. With that form the investigator applies for supervisors consent on taking on a side job conform article 9.3 of the UMC- Collective Labor Agreement (CAO). 

Next to this, investigators are required to take a web-based NIH tutorial on financial conflict of interest prior to beginning a project: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm.
An electronic copy of the tutorial’s certificate has to be sent to rso@umcutrecht.nl. 

If a Financial Conflict of Interest is identified, proper measures will be taken to mitigate the conflict of interest, as described in the collective labor agreement for university medical centres in the Netherlands, Article 9.3.