Health Research

Published 12.1.2012 

- godkjent av Fellesorganet for REK 3.6.2010

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  • The Health Research Act applies to medical and health research on Norwegian territory or when the research takes place under the auspices of a Research Manager (Institution Responsible for Research) who is established in Norway.

  • Research is an activity that makes use of scientific methodology. A project that does not make use of scientific methodology or that does not meet scientific goals cannot be approved under the Health Research Act.

  • Medical and health research is research on humans, human biological material and personal health information, which aims to generate new knowledge about health and diseases. The purpose is decisive; not whether the research is carried out by health professionals or on patients or makes use of personal health information.

  • Research on humans is research that involves direct contact with research participants by intervention and invasive studies (clinical trials of drugs, surgeries), the collection of human biological material (blood samples, tissue samples) or by obtaining personal health information through direct contact (interview, observation, questionnaires).

  • Human biological material is organs, parts of organs, cells and tissue, and the constituents of such material from living and deceased humans collected for research purposes (a specific or general research biobank) or collected for clinical use (a diagnostic or treatment biobank).

  • A research biobank is a collection of human biological material used in, or to be used for, research.

  • A specific research biobank is a biobank connected to a specific research project. A specific research biobank must be described in the project's protocol and be part of the ordinary project application to REC.

  • A general research biobank is a research biobank for future research or for the storage and possible new use of human biological material when the original purpose of a specific biobank is fulfilled. A general research biobank whose purpose is thematically defined is called a thematic research biobank. A general research biobank shall be considered for approval by REC using a separate biobank application form.

  • Personal health information is confidential information in accordance with section 21 of the Healthcare Personnel Act and other information and assessments regarding health conditions or which is of significance to health conditions, which can be associated with an individual. Personal health information may be collected for research purposes or for clinical use. Anonymous information, ie. information that cannot be traced back to individuals is not personal health information according to the Act.