Last updated 01.07.2025
General about REK KULMU
Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU)
REK KULMU is administratively affiliated with REK south-east, but has a national mandate where the committees are to carry out research ethics assessments of clinical trial applications on medicinal products and medical devices.
REK KULMU was established in the fall of 2020, and in collaboration with the Norwegian Medicines Agency (NoMA), applications are assessed according to the EU regulations Clinical Trials Regulation 536/2014, CTR, Medical Device Regulation 2017/745, MDR and In Vitro Diagnostic Medical Device Regulation 2017/746, IVDR and other associated regulations.
The two REK KULMU committees assess both applications concerning clinical trials of medicinal products and medical devices. REK KULMU assess applications regularly beyond REK’s ordinary deadlines and committee meetings.
The overall aim of the regulations is to harmonise and simplify the application process for clinical trials in Europe, strengthen safety for study subjects and ensure openness and transparency concerning clinical trials.
The EU has established the MedEthicsEU network, which aims to strengthen the cooperation between ethics committees in Europe that assess applications under the three regulations.
In addition to this, the secretariat of REK KULMU is involved in the EU initiatives COMBINE and CTR collaborate.
COMBINE aims to identify the challenges faced by sponsors, regulatory authorities and ethics committees when conducting combination studies (applications involving the testing of drugs and medical devices), and to identify possible solutions to these challenges.
CTR collaborate aims to identify bottlenecks and challenges with CTR and CTIS, find good solutions, establish common procedures for drug regulatory authorities and ethics committees, and ensure that these are communicated to stakeholders.
