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12. Conflicts of interest

12. Conflicts of interest

12.1 Introduction

 
Members of the research staff are expected to apply the knowledge and expertise for which they were appointed in the interest of their institute, namely the AMC and the VUmc, respectively. They need to guard against conflicts of interest, as defined below. Lack of independence can result in substandard science, damage the reputation of the researcher and that of his/her research group, reduce transparency and diminish the institute's standing, and ultimately even adversely affect patient care. The increasing need to acquire external funding and the significant interests that the funding bodies have in the research carried out at academic medical centres can jeopardize researchers' independence. The AMC and the VUmc endorse the Code for the prevention of improper influence due to conflicts of interest . This chapter discusses the principles and procedures in situations where conflicts of interest might arise, specifically when collaborating with external parties and when working under external employment. *1

*1: References for this chapter:
Online disclosure of physician-industry relationships. Perspective, N Engl J Med, 360, 2009, 325-327.
Sponsorship, authorship, accountability. Editorial, N Engl J Med, 345, 2001, 825-827.

12.2 Definition

 
A conflict of interest occurs when researchers or their institutes have financial or personal ties with other persons or organizations that influence their work. The extent of this influence ranges from negligible to very substantial. Financial relationships (such as appointments, consultancies, stock ownership, fees, paid advice) are the sources of conflict of interest that are the easiest to identify and the most likely to undermine credibility. A conflict of interest can sometimes exist without the researcher being aware of it.

Conflicts of interest are often associated with the interests of pharmaceutical companies, but they can also stem from personal relationships, academic competition and intellectual passion. Research sponsored by the government, semi-governmental bodies or other funding agencies can also give rise to conflicts of interest. Examples of situations that may give rise to conflicts of interest are given below.

12.3 Collaboration with commercial parties


The AMC and the VUmc advocate that, whenever feasible, the results of scientific research be rapidly converted into new diagnostic and therapeutic tools in order to allow patients to benefit from innovations as soon as possible. This usually involves a process that necessitates collaboration with commercial companies - and this is where the danger of conflict of interest arises. The collaboration may in no way cast doubt on the independence of the research performed at the AMC/VUmc. Such doubt threatens the academic careers of individual researchers, who could be barred from publishing in leading journals or not considered for particular forms of funding. In addition, funding bodies sometimes demand transparency on potential conflicts of interest of researchers applying for grants. The arrangements that can be made to safeguard independence when setting the research question, gathering and analysing data, and publishing the results of research in collaboration with external funding bodies are described in Chapter 8. See also the brochure Naar een goede waarde of the Netherlands Federation of University Medical Centres (NFU) and the Richtlijn Gunstbetoon door bedrijven (NFU). Financial relations between medical doctors working at UMCs and commercial parties can be consulted at the Transparantieregister .

12.4 External employment


Article 9.3 of the Collective Agreement for University Medical Centres (CAO, 1 March 2011 - 1 April 2013 ) includes rules on external employment (nevenfuncties) that apply to all employees covered by the CAO. External employment, remunerated or otherwise, is not permitted if these external duties are incompatible with the employee's responsibilities at the AMC/VUmc or could interfere with the interest or reputation of AMC/VUmc. The CAO therefore contains rules that require external employment to be reported, and in specific cases makes it subject to explicit approval by the executive board (see below). Further information on the application of the rules on external employment can be obtained from the business manager of the division or department, and from CAO article 9.3.

Article 9.3 of the CAO for University Medical Centres stipulates the rules that the parties to the CAO have agreed upon concerning the external activities of staff of teaching hospitals:

  1. Employees do not require the employer's prior consent to accept or perform external activities, unless those activities could affect the interests of the university medical centre (UMC) and/or the proper performance of their job.
  2. The employer shall grant permission to perform external activities if in its opinion the performance of those external 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 external activities wholly or partially during their working hours.
  3. 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 external 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.
  4. The employer may withdraw the permission that has been granted if it considers that the circumstances under which the permission was granted have changed.
  5. If it emerges that an employee is performing or has performed external 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.
  6. In consultation with the works council, the employer may lay down further rules for the administrative implementation of the provisions of this article.

De regeling nevenwerkzaamheden VUmc .

12.5 Procedures for reporting potential conflicts of interest

 
Based upon the guidelines of the Netherlands Federation of University Medical Centres (Nederlandse Federatie van Universitair Medische Centra; NFU ), the AMC and the VUmc have established the following procedures to handle potential conflicts of interest.

  • Provide transparency
    In order to safeguard the independent position of the researcher and the standing of the AMC and the VUmc as research institutes, researchers should report any external employment that might lead to conflicts, including financial ones, of interest to their head of department or division, and disclose it on their personal page on the 'Who is Who' section of the AMC's website or via the department website of VUmc . They should also report the agencies that fund their research on this page. Although disclosure itself does not eliminate bias or conflicts of interest, it can make financial relationships widely known and be used as a starting point for asking questions. Those who participate in the scientific process must clarify any relationships they have that could potentially give rise to a conflict of interest. This applies not only to situations where there is a demonstrable conflict of interest, but also to situations that could create that impression.
  • Discuss the matter during the annual interview
    Potential conflicts of interests must be an item during the annual interview (jaargesprek) between the researcher and his/her head of department or division. If there is any doubt whether there is a potential conflict of interest, the researcher must report this to the business manager of the division (directeur bedrijfsvoering).
  • Report to business manager
    Researchers are required to report immediately to the business manager of their division if they believe they might be caught up in a conflict of interest or are exposed to potentially conflicting interests outside the institute. The business manager will inform the head of the department of all such notifications. The examples given below of situations that could entail a conflict of interest can be used as a checklist.

The notification may be discussed with the legal advisor to the executive board, if appropriate. The researcher will be consulted as to how the situation can best be dealt with. The researcher can also initiate consultations of this kind. The executive board may decide to publish notifications. Both the notification and any approval granted by the executive board are recorded in the employee's personnel file. If no such notification is received, it will be assumed that there is no potential conflict of interest and that the employee can prove this if necessary.

12.6 Examples of situations that may give rise to conflicts of interest


The Association of American Medical Colleges provides the following examples of situations that may give rise to conflicts of interest

Situations that may increase the potential for bias in research

  • Undertaking basic or clinical research when the investigator or the investigator's immediate family has a financial, managerial or ownership interest in the sponsoring company or in the company producing the drug/device under evaluation.
  • Accepting gratuities or special favours from research sponsors.
  • Entering into a consultancy arrangement with an organization or individual that/who has an economic interest in related research. Situations that may invoke inappropriate use of institutional assets and resources in research.
  • Using students or employees of the institute to perform services for a company in which a faculty member has an ownership interest or from which he/she receives any type of remuneration.
  • Unreimbursed or unauthorized use of institutional resources (e.g. equipment, supplies or facilities) for personal purposes or to support the activities of an independent entity in which an investigator holds a financial or other interest.
  • Associating one's name or one's work with the institution in such a way as to profit monetarily by trading on the reputation or goodwill of the university or hospital, rather than on one's professional competence.

Situations that may lead to inappropriate use of information

  • Unauthorized use of privileged information acquired in connection with one's professional responsibilities.
  • Accepting support for basic or clinical research under terms and conditions that require results to be kept confidential, unpublished or significantly delayed in publication.
  • Providing privileged access to information that was developed with university resources or supported by independent sponsors to an entity in which the faculty member has a financial interest.
  • Situations that may lead to self-dealing
  • Purchasing equipment, instruments or supplies for research or teaching from a firm in which the faculty member has a financial or other interest.
  • Influencing the negotiation of contracts between the academic institution and external organizations with which a faculty has a financial interest or other relationship.
  • Requiring or recommending one's own textbook or other teaching aids.

 

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