Quality Assurance in the Committee System

The legal committee behind the current committee law has recommended continuous work on quality development, quality assurance, and forward-looking learning in the committee system, including through test cases, audits, and educational programs. It was the committee's view that the development of this area could strengthen the committee system.

The purpose of an audit is to ensure greater uniformity and transparency in case handling for the benefit of both trial participants and users of the system.

Therefore, § 33 of the Committee Act, which came into force on January 1, 2012, states that the committee system must ensure quality development, quality assurance, and learning. The act's remarks refer to Report No. 1515, March 2010, from the mentioned committee on revision of the scientific ethical committee system.

The Committee Act's remarks state that audits, among other methods, can be conducted according to the committee's instructions, and the committee system's work with quality development, assurance, and learning should take place in close cooperation between the national committee and the regional committees.

Quality assurance and development should occur in a learning perspective and not for control purposes. An audit can help ensure uniform quality in decisions and handling of notifications regardless of which committee processes the notification.

The National Scientific Ethics Committee (NVK) conducted an audit in 2014.

Scientific ethics focus on setting stricter requirements for projects involving children. Children are a vulnerable patient group and, as a starting point, cannot consent to participate in a health scientific research project. Their ability to understand the project is naturally limited in relation to the stage of maturity, and there are requirements for pedagogical information for children participating in research projects. Assessment of projects with children also requires expertise from a specialist in pediatric diseases, as children's bodies react differently than adults.

The audit report thus focused on children's projects.

The conclusions were as follows:

  • 70% of the notifications suffer from formal deficiencies, which could have been corrected before submission to the committee, thus prolonging the processing time.
  • In every other notification, the ethical balance between the experiment's risk and the benefit for the child/patient group is not described.
  • Half of the notifications do not focus on child information from a person with special pedagogical qualifications.
  • Committees rely on expert statements from pediatricians in their case handling.
  • All trials are approved, possibly with conditions.
  • Acknowledgments are sent within a week in just over half of the cases. After 14 days, about a third of the notifications still have not received acknowledgment.
  • The database information is correct in about 90% of cases.

Note that the first three bullets relate to the quality of the notification and not of the approved project.

The report has resulted, among other things, in the NVK secretariat initiating work to develop a new website aimed at researchers and other stakeholders about the notification and implementation of health scientific projects.

Templates have also been developed for the committees' inquiries to specialists in projects that require specialist assistance.

It is then planned that future quality assurance work of the committee system will take place with inspiration from abroad, as it has been decided to take the committee system in England as a starting point.


An essential part of quality assurance is the education of committee members. NVK members and the secretariat occasionally give presentations on various topics in the committee system and other forums.

Every four years, NVK initiates an education day for new committee members. A brochure, Learn about Science Ethics, has also been developed, serving as an introduction to the committee system.

Last updated 01-02-2024

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