Financial Conflict of Interest Policy related to NIH-funded research at the University Medical Centre Utrecht
All researchers of the University Medical Centre Utrecht are asked to inform 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.
Institutional policy on financial conflicts of interest (FCOI) related to NIH-funded research at the University Medical Centre Utrecht (UMC 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).
Article 9.3 Outside activities (Collective labor agreement for university medical centres in the Netherlands 2015-2017):
- Employees do not require the prior consent of the employer for the acceptance or performance of outside activities, unless those outside activities could affect the interests of the UMC and/or the proper performance of their job.
- The employer shall grant permission for outside activities if in its opinion the performance of those outside activities cannot damage the interests of the UMC and/or affect the proper performance of the job. If it is in the interests of the UMC, the employer may agree to allow employees to perform their outside activities wholly or partially during their working hours.
- The employer shall grant permission for a fixed period or for an indefinite period and may attach further conditions to its consent. The employer may stipulate the condition that the employee must pay all or part of the income that he earns from outside activities to the employer. This condition may be stipulated for income that exceeds €2,200 a year and is earned from activities that follow from the employee’s job at the UMC.
- The employer may withdraw the permission that has been granted if it considers that circumstances under which the permission was granted have changed.
- If it emerges that the employee is performing or has performed outside activities without the permission required by virtue of the first paragraph, the employer shall still give the employee the opportunity to request the necessary permission. If the permission is not granted, the employer may, without prejudice to the provisions of Article 11.1 (dereliction of duty) instruct the employee to cease the activities and/or pay the income earned to the employer.
- In consultation with the works council, the employer may lay down further rules for the administrative implementation of the provisions of this article.
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 formally agreed collective labor agreement for the university medical centres (CAO UMC) in the Netherlands 2015-2017.
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:
An electronic copy of the tutorial’s certificate has to be sent to email@example.com.
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.