What is "medical and health research"?
The Health Research Act and the guide to the Act provided by the Ministry of Health and Care Services (English translation) define what falls within and outside the concept of "medical and health research" in Norway. If in doubt, the project manager should contact the regional committee for medical and health research ethics (REK) before the application is submitted.
The text below is a summary:
Classified as "medical and health research":
- Research in medicine and health disciplines conducted using scientific methods with the aim of acquiring new knowledge about health and disease. A protocol describes a problem formulation to be investigated or a hypothesis to be tested using the scientific method. The terms "health" and "disease" should be interpreted broadly.
- Research on rehabilitation.
- Pilot studies and experimental treatment.
- Development work – that is, systematic activities that apply existing knowledge from research and practical experience to develop new or improved products, processes, systems, and services that can be characterized as research.
- Research on human biological material, including anonymized material.
- Establishment of a research biobank -- a collection of human biological material that is used in a research project or that will be used for research.
- Clinical trials of medicinal products on humans. Here, an application must also be sent to the Norwegian Medicines Agency (Statens legemiddelverk).
- Clinical trials of medical equipment. In addition, the Norwegian Directorate of Health must be notified no later than 60 days before the trial begins.
- Clinical trials involving gene therapy. These must also be evaluated by the Directorate of Health in terms of the Biotechnology Act and the Gene Technology Act.
If anonymized data are to be used, it is not generally necessary to apply to REK. When such data are used, it must be possible for the Data Protection Officer to confirm that the material had been anonymized when it was released.
Outside the concept of "medical and health research":
Research that uses personal data, but that falls outside the scope of the Health Research Act, must be reported to the Norwegian Social Science Data Services (NSD). The same applies to quality assurance projects. Health registers that are not established in connection with specific research projects must be approved by the Data Inspectorate.
- Processing of health information for purposes other than acquiring new knowledge about health and disease, such as social science research.
- Evaluation of funding systems in the health sector.
- Anthropological research on cultural interpretations of illness.
- Quality assurance projects that deal with personal data. Quality assurance is defined as projects, surveys, examinations, evaluations, assessments, etc., which are aimed at ensuring that diagnosis and treatment actually produce the intended outcomes. Such projects do not use scientific methodology and they are not intended to generate new knowledge about health and disease.
- Establishment of health registers, unless this forms part of a specific research project that is defined as medical or health research.