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Home / REK

Regional committees for medical and health research ethics

REK is responsible for assessing whether research projects are ethically justifiable to carry out.

For all medical and health research involving humans, human biological material or health information, prior approval must be sought from REK.

REK illustasjon

For applicants REK

Information about REK, application forms, etc.

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For those who are submitting a new application or following up ongoing projects

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Next deadline August 19

The deadlines apply to submission for approval of a new application. The deadline expires at 23:59 on the specified date.

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When should you apply to REK?

Guidance for those who are wondering if you need to submit an application to REK

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When should you send a "endringsmelding"?

Guidance on which project changes require approval from REK

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Templates

Template for information letter and consent

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Illustrasjon av leger

Current messages

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  • 20. Jun 2025

Update

New layout in the REC portal

The REK portal has undergone a necessary upgrade that involves some changes in appearance and layout. Here is an...

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  • 17. Jan 2025

Response

Read REK’s response to the Ministry of Health and Care Services’ proposal for amendments to the Health Research Act

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  • 24. Nov 2024

How to activate 2-step verification when logging in to REK-portalen

It is now possible for users of the REK portal to activate 2-step verification when logging in to REK-portalen....

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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
    • Postjournal
  • Application form
    • Prosjektsøknad
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
    • CTIS
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  • About REK / REK KULMU
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    • About REK KULMU
    • Prosjektregister
    • Postjournal
  • Application form
    • Prosjektsøknad
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    • EU application portal CTIS
    • General requirements and recommendations for a CTR application
      • Modification application CTIS
      • Part I application
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        • 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
    • Generell biobank
    • Dispensasjon fra taushetsplikt annen forskning
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  • Templates REK KULMU
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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
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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