The National Bioethics Committee operates on the basis of legal acts and regulations for the Committee. Regulation nr 286/2008 on biomedical research involving humans, based on the Patients Act from 1997, is the most important one. A number of legal acts, regulations and rules also apply in this context i.a. the Administrative Act, Act on Patients Records, Act on Biobanks, Act on Personal Integrity etc.

Furthermore, international agreements have important impact and contribute to defining the mode of operations and the criteria applied by the NBC. This is particularly important for the extensive collaboration of Icelandic scientists in international biomedical research.