Norway

Legislation

  • The Act on Medical and Health Research (Health Research Act) was passed on June 5 2008, and implemented on 1 July 2009. This replaced the Personal Data Act, the Personal Health Data Filing System Act, The Act on Biobanks and the Act on the Application of Biotechnology in Human Medicine Health with regard to medical and health research. Research biobanks and research involving human biological material are regulated in Chapter 6 [In English].
  • Personal Data Act (PDA) (Act of 14 April 2000 No. 31.)[In English]
  • Personal Health Data Filing System Act 2001 (Act of May 2001 No. 24 on Personal Health Data Filing Systems and the Processing of Personal Health Data) [In English]
  • Norwegian Biobanks Act (2003), since modification in 2008 it is entitled the Act on Treatment Biobanks and regulates the establishment of diagnostic and treatment biobanks [English translation of 2003 version]
  • Act on the Application of Biotechnology 2003 (Act of 5 December 2003 No.100 relating to the application of biotechnology in human medicine,etc (Biotechnology Act)). A new revised Act passed Parliament on May 24, 2007 [In English]. Since 2008 parts of this Act still apply to research using genetic data.
  • Other Legislation includes: The Penalty Act when biological samples are also collected for forensic purposes;  the Public Administration Act (1967) and The Health Personnel Act (1999) which regulate confidential information both generally and in relation to medical and health research in the Health Personnel Act.
  • Act on Research Ethics (2006) - made the system of research ethics committees part of the legal system.

Guidance

  • No practical guidance in Norway on using BBGDs.

Biobanks/Genetic Databases

  • The Norwegian Institute of Public Health runs a register of establishment of research, diagnostic and treatment Biobanks, which can be accessed online (in Norwegian). Accessing the website on 19 Jan 2010 shows that 1712 research biobanks have been established in Norway since 1. July 2003 (245 from before that date). There is information on 182 diagnostic and treatment biobanks. Both types of biobanks contain several million samples.
  • Biobanks for Health (Biohealth Norway) has been established, which includes biological samples from the CONOR nationwide epidemiological database and the Norwegian Mother and Child study. Biohealth Norway has been established through the extension and cooperation of already existing epidemiological surveys, contrary to the ideas of the establishment of one large national research biobank. The website provides information on ongoing data collection and access conditions.
  • The Nord-Trøndelag health study (HUNT)