Regulatory Framework
According to the Committee Act, individuals involved in making decisions about the approval, monitoring, or supervision of health science and health data research projects must not have financial or other interests in health science research that could affect their impartiality.
The purpose of the rules on conflicts of interest is to ensure that decisions are made on an objective basis, where irrelevant interests do not enter the decision-making process, so that the public can trust the decisions made.
Therefore, all members of a regional or national ethics committee, employees of the associated secretariats, and other individuals attached to the committees who participate in the processing of research projects, must annually declare their financial and other interests in health science research to the committee to which they are affiliated.
Since the ethics committees are part of the public administration, they are also subject to the general rules of conflicts of interest as described in the Public Administration Act.
Resources
Act No. 1338 of September 1, 2020, on the Ethical Treatment of Health Science Research Projects and Health Data Research Projects ("Committee Act")
Act No. 433 of April 22, 2014, on the Public Administration Act
Declaration of Conflicts of Interest
The National Ethics Committee (NVK) has developed a form for gathering information about personal and financial matters, which is used throughout the committee system.
To ensure transparency and openness regarding conflicts of interest in the committee system, the declarations of all committee members and secretariat employees are published on the respective committees' websites. Declarations must be updated at least annually or continuously if new circumstances arise that could lead to a conflict of interest.
Resources
Form for declaration of conflicts of interest (PDF)
Circumstances That Can Lead to Conflicts of Interest
NVK has developed guidelines to support the committees' assessment of conflicts of interest, ensuring uniform assessment across the committees. The guidelines have been discussed with the regional committees.
According to the guidelines, the following situations may lead to conflicts of interest in connection with the application for approval of a specific research project:
- Being an applicant, co-applicant, or other participant in the project.
- Having personal or economic interests in the project, either oneself or a close relative.
- Having close professional, personal, or financial relationships with the applicant, co-applicant, or other project participants.
- Being a board member of the public institution from which the project originates.
- Being a leader with direct instructional authority over the applicant, co-applicant, or other project participants at the public institution from which the project originates.
- Having been on the board and/or management of a private company participating in the project within the last five years.
- If the project originates from a research group of which one is or recently has been a member.
- If one has previously participated in the processing of the project in a regional ethics committee.
- If one has previously represented the applicant, co-applicant, or other project participants in the specific project.
The respective committees and/or secretariats assess questions of conflicts of interest. The person presumed to be in a conflict must not participate in assessing their own situation. Discussions of conflicts of interest should be documented, e.g., in the minutes of the relevant meeting.
It is the responsibility of the concerned individuals to alert if changes occur in their circumstances. The same applies if one becomes doubtful about their own impartiality during the processing of a specific case.
Resources
Guidelines for conflicts of interest (PDF)
Handling of Sensitive Personal Data
In collecting declarations of conflicts of interest, personal data such as name, workplace, title/position, email, and possibly financial and family-related information are collected and registered. The committee system's handling of personal data can be disclosed in connection with the collection of conflict of interest declarations.
The committee system stores this information in a journaling system inaccessible to external parties. However, sensitive personal data will not be published in the public declarations of conflicts of interest. Information about the value of shareholdings and relatives' connections to companies, for instance, will not be disclosed.
Resources
Information letter about handling sensitive personal data in the committee system (PDF)