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R&D regulations

Relevant legislation for research projects

Depending on the project plan and research design, the following acts and regulations may be relevant.

Act respecting the right to employees' inventions 

The act provides the employer with all rights to commercial exploitation of an employee's invention, given that the employee in question is remunerated.

Act respecting the right to employees' inventions (.pdf)

Act relating to biobanks

The act regulates the use of biological material that is part of a biobank.

Act relating to biobanks (.pdf)

Designs Act

Through this act, the creator of a design (the designer) may acquire by registration protection of the product design (i.e. the appearance) and an exclusive exploitation right; i.e. produce, introduce to the market, sell etc. 

Designs Act

Forskrifter til helseregisterloven (in Norwegian only)

Forskriftene gir utdypende bestemmelser til Helseregisterloven. Det er egne forskrifter for de store sentrale registrene, som Dødsårsaksregisteret, Kreftregisteret, Medisinsk fødselsregister etc.

Forskrifter til helseregisterloven

Forskrift om klinisk utprøving av legemidler til mennesker (in Norwegian only)

Forskriften gir regler om klinisk utprøving, herunder multisenterutprøving, av legemidler til mennesker, og gjelder utprøving både på pasienter og på friske personer.

Forskrift om klinisk utprøving av legemidler

The Public Administration Act

The act is a general administration act that regulates the administrative procedure of all public bodies. It applies to state-owned, municipal, regional and local administrative bodies.

The Public Administration Act

Gene Technology Act

The purpose of the act is to ensure that the production and use of genetically modified organisms and the production of cloned animals take place in an ethically justifiable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on health and the environment.

Gene Technology Act

The Health Research Act

The purpose of the act is to promote good and ethically sound medical and health research and it applies to all medical and health research on human beings, human biological material or personal health data.

The Health Research Act

Helseforskningsforskriften (in Norwegian only)

Forskriften gir nærmere regler om organiseringen av medisinsk og helsefaglig forskning; blant annet om internkontroll, forskningsansvarliges plikter og prosjektleders plikter.

Forskrift om organisering av helseforskning

The Health Personnel Act

The act should contribute to safety for patients and quality within the health service as well as trust in both health personnel and the health service.

The Health Personnel Act

The Research Ethics Act

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

Act on Ethics and Integrity in Research (.pdf)

Act relating to the protection of layout-deigns for integrated circuits

The act regulates the exclusive right to layout-designs for integrated circuits, including its scope and limitations.

Layout-designs Act (.pdf)

Pasient- og brukerrettighetsloven (in Norwegian only)

Loven skal bidra til å sikre befolkningen lik tilgang på helsehjelp av god kvalitet ved å gi pasienter rettigheter overfor helsetjenesten.

Pasient- og brukerrettighetsloven

Patents Act

The act lays out the conditions for obtaining a patent, the legal effects of patenting, the actions which are subject to the consent of the patent holder as well as the extent of the patent.

Patents Act

Personal Data Act

The purpose of the act is to protect natural persons from violation of their right to privacy through the processing of personal data. 

Personal Data Act (.pdf)

Personal Data Regulations

The regulations provides detailed rules for the use of personal data

Personal Data Regulations (.pdf)

Act relating to universities and university colleges

In some cases the act regulates the administrative procedures of universities and university colleges, while in other cases it simply lays down guidelines for the internal regulations of the individual educational institution.

Act relating to universities and university colleges (.pdf)

Trademarks Act

Through this act an inventor may acquire an exclusive right to commercial exploitation of a trademark, i.e. to use a trademark consisting of figures, words or word connection as a distinctive sign for goods and/or services.

Trademarks Act

Åndsverksloven (in Norwegian only)

Loven beskytter åndsverk; dvs. litterære, vitenskapelige og kunstneriske verk, samt prestasjoner som har tilknytning til åndsverkene. Innenfor de grenser som er angitt i denne loven, har skaperen av åndsverket enerett til å råde over åndsverket i form av tilgjengeliggjøring og eksemplarframstilling.