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Home / REK / About REC
  • About REC

About REC

Regional committees for medical and health research ethics (REC)

Pre-approval from REC
The regional committees for medical and health research ethics must give pre-approval:

  • Medical and health research projects
  • General research biobanks
  • Exemption from confidentiality for other types of research

General inquiries should be directed to the REC in the geographical region to which you belong.

Inquiries about submitted applications and cases should mainly be made via the portal or directed to the REC region that processes the case.

E-mails should be sent to post@helseforskning.etikkom.no with the name of the relevant REC/committee in the subject field (REK sør-øst A/B/C/D, REK vest, REK midt or REK nord)
The committee secretariats can be contacted by phone or e-mail. Meetings with the secretariat/case officer should be arranged in advance. See information for the individual REC and secretariat in the individual tabs.

  • REK south-east: Agder, Vestfold and Telemark, Viken, Oslo, Innlandet
    • E-mail: rek-sorost@medisin.uio.no
  • REK west: Rogaland, Vestland
    • E-mail: rek-vest@uib.no
  • REK Central: Møre and Romsdal, Trøndelag
    • E-mail: rek-midt@mh.ntnu.no
  • REK North: Nordland, Troms and Finnmark, Svalbard
    • E-mail: rek-nord@asp.uit.no

 

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REK

General inquiries should be directed to the REK in your geographical region.

REK KULMU

For questions regarding the ethical assessment of clinical trials under CTR, MDR, and IVDR, please contact via email: rek-kulmu@medisin.uio.no

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  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
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  • About REK / REK KULMU
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    • About REK KULMU
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  • Application form
    • Prosjektsøknad
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REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions
  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
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  • Application form
    • Prosjektsøknad
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  • Templates REK KULMU
  • EN
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  • About REK / REK KULMU
    • About REK
    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
  • Templates REK KULMU
  • EN
  • NO
Project register

REK

  • About REC

REK KULMU

  • REK KULMU Comittees
  • Meetings
  • REK KULMU
  • Clinical Trials Regulation (CTR)
    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
      • Part II application (national application)
        • Recruitment
        • Information to study participants and consent form
        • Suitability of the investigator
        • Suitability of the facilities
        • Proof of insurance cover or indemnification
        • Financing and other arrangements
        • Compliance with national requirements on Data Protection
        • Compliance with use of biological samples
          • Use of biological material for future research
  • Clinical investigations of medical devices (MDR)
    • Application to REK for MDR studies
    • Clinical trials of medical device that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification applications to NoMA
  • Clinical investigations of in vitro diagnostic medical devices (IVDR)
    • Application to REK for IVDR studies
    • Performance studies that are subject to application or notification to NoMA
    • Combination trials
    • Storage period of personal data
    • Modification application performance studies
  • Information forms CTR/MDR/IVDR
    • Inclusion of minors in reserach
    • Informed consent forms for broad consent
  • Templates REK KULMU
  • Answers to frequently asked questions