History of the Committee System

The Danish ethical committee system in the field of biomedical research began voluntarily in 1980 as an initiative among biomedical researchers. This was based on the Nuremberg Code from 1947 and the Declaration of Helsinki.

The second Helsinki Declaration was adopted by the World Medical Association on October 2, 1975. Denmark immediately took the first steps to create independent committees, and the committee system was described in a report from March 28, 1977. As the first country in the world to decide to establish a nationwide, independent system, Denmark was free to choose its structure, professional scope, membership, etc., a possibility that was fully utilized.

In the proposal for Act No. 353 of June 3, 1987, on the establishment of an ethics council and regulation of certain biomedical experiments, it was indicated that work would be initiated to determine the need for legal rules on biomedical experiments on living subjects.

This resulted in Act No. 503 of June 24, 1992, on an ethical committee system and the treatment of biomedical research projects. The law primarily aimed to create legally binding frameworks for the ethical assessment of biomedical research projects. Therefore, it included rules for establishing an ethical committee system, mandatory notification of biomedical research projects, and the general principles for the assessment of projects.

Act No. 402 of May 28, 2003, on an ethical committee system and the treatment of biomedical research projects, came into force on May 1, 2004. The background for this law, which brought significant changes compared to the previous committee law, was both the practical experience gained from the committee work and new international regulations in the bioethics field:

The Council of Europe adopted the Convention on Human Rights and Biomedicine on April 4, 1997, which Denmark has signed and ratified.
The Council of the European Union adopted a direktiv om god klinisk praksis in January 2001 on good clinical practice in conducting clinical trials of medicinal products for human use – the GCP Directive.

In spring 2006, a minor amendment to the committee law (Act No. 272 of April 1, 2006) was made. This included the implementation of EC Directive 2005/28/EC of April 8, 2005, on principles and detailed guidelines for good clinical practice concerning test preparations for human use and requirements for manufacturing and importing such preparations. According to the directive and now the committee law, the interests of the test subject's rights, safety, and well-being take precedence over scientific and societal interests in creating new, valuable knowledge.

In spring 2009, the Minister for Health and the Elderly (previously called the Ministry of Health and Prevention) established a broadly composed committee tasked with drafting a report on revising the ethical committee system with a view to revising the legislation. The committee presented its [Report No. 1515](link to the report) in March 2010.

Based on this report, the Minister of the Interior and Health presented the proposal for the Act on the Ethical Treatment of Health Science Research Projects, L 169, on March 17, 2011. The bill was passed on June 1, 2011, with effect from January 1, 2012.

The current law is thus Act No. 593 of June 14, 2011, on the ethical treatment of health science research projects.

The latest amendment to the existing committee law is Act No. 604 of June 18, 2012, amending the law on the ethical treatment of health science research projects.

Last updated 01-02-2024

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