The EU regulation Clinical Trials Regulation 536/2014, CTR entered into force on January 31, 2022. On behalf of the ethics authorities in Norway, REK KULMU carries out the research ethics assessment of applications that fall under CTR. The assessments are made in accordance with general research ethics principles. CTR is the overriding legislation, but the ethical principles described in the Health Research Act will apply matters that are not mentioned in CTR.
We refer to NoMA’s website for more information on clinical trials under CTR.
