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• Act n. 44 on medical and health research, June 20, 2008:

Purpose

"The purpose of the Act is to promote good and ethically sound medical and health research."

Scope

Substantive scope of the Act:

"The Act applies to all medical and health research on human beings, human biological material or personal health data. Such research also includes pilot studies and experimental treatments.
The Act does not apply to establishment of health registers.
Unless otherwise provided by this Act, the Personal Data Act and appurtenant regulations apply as supplementary provisions. Clinical testing of medicinal products on human beings is covered by Section 3 of the Medicines Act and appurtenant regulations. Clinical testing of medical equipment is covered by the Act on Medical Equipment and appurtenant regulations. In this context, the provisions of this Act apply as a supplement, where relevant.
The Ministry may by regulations lay down provisions concerning the application of the Act in special areas within medical and health research."

Territorial scope of the Act:

"The Act applies to research conducted on Norwegian territory or if the research is being done under the direction of a person or body responsible for the research established in Norway.
The Act does not apply to use of personal health data if the person or body responsible for the research is established in another EEA State. Nor does the Act apply to use of personal health data if the person or body responsible for the research is established in a state outside the EEA Area and the institution does not use tools in Norway for purposes other than pure transfer of personal health data.
The King may by regulations decide the extent to which the Act will be applied in Svalbard and Jan Mayen."

• Act n. 99 amendind the Patients' Rights Act and the Biobank Act (health care and research- persons without competence to give consent), December 22, 2006:

Purpose

This Act seeks to provide "necessary health care in order to prevent significant harm to health and to prevent and limit the use of force."

"Health care shall be provided in such a way as to ensure respect for the individual's physical and mental integrity, and shall as far as possible be in keeping with the patient's right to self-determination."

It creates a Chapter 4 A: "Health care for patients without competence to give consent who object to health care, etc."

Scope

It "shall apply when health personnel provide health care to patients over 16 years of age who lack competence to give consent".

However, it does not apply  for the examination and treatment of mental illness without the patient's own consent  which fall in the scope of the Act of 2 July 1999 No. 62 relating to Mental Health Care.

• Act of 30 June 2006 No. 56 on ethics and integrity in research, June 30, 2006:

Purpose

This Act seeks to ensure that research carried out by public and private institutions is conducted in accordance with recognised ethical standards.     

• Act n. 12 relating to biobanks, February 21, 2003:

Scope

“This Act applies to the collection, storage, processing and destruction of human biological material and information that forms part of a biobank, including the organisation of these activities.

Unless otherwise provided by this Act, health data and personal data derived from human biological material shall be processed in accordance with the provisions of the Personal Data

Act, the Personal Health Data Filing System Act, the Health Personnel Act and any other legislation that specifically regulates the protection of personal data.

Biological material that is taken for the purpose of medical examination, diagnosis and treatment and that is destroyed shortly afterwards does not come within the scope of this Act.

The Act nevertheless applies if such material is used for research purposes.”

• Regulations n. 511 relating to the transfer of biobank material to others countries, February 26, 2004:

Purpose 

“The purpose of these regulations is to regulate exemptions from the general rule that approval from the Ministry is required if biobank material is to be transferred to another country. Exemptions may be made if the interests of ordinary international cooperation indicate that this is justifiable and appropriate, and if the biobank material will be used for the benefit of individual people and of society as a whole. The regulations are intended to ensure that such transfers of biobank material to other countries take place within a satisfactory framework.”

 The Norwegian rules to export

The editorial staff is writing this section...

The editorial staff is writing this section...