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Approvals for medical and health research

Information about applications to REC and other bodies.

Approvals

For medical and health research on humans, human biological material or personal health data, it is a prerequisite that projects are pre-approved. These pre-approvals should according to the Health Research Act be sent to the Regional Committees for Medical and Health Research Ethics (REC).

It is the purpose of the research project which is crucial when deciding whether a project should be approved by REC according to the Health Research Act, or whether it should be reported to the Data Protection Official according to the Personal Data Act/Personal Health Data Filing System Act. Some research projects must in addition to REC-application also apply to or notify other agencies of the project. This applies to clinical testing of medicines on humans, clinical testing of medical devices and research projects that come under the rules and regulations of the Biotechnology Act.

Research on patient- and personal health records for other purposes, e.g. social sciences, are regulated by the Personal Data Act and must be notified to the Data Protection Official/The Norwegian Data Protection Authority.

Use of previously collected data in research may require new approvals. Please contact REC for clarification.

Regional Committees for Medical and Health Research Ethics

REC (Regional Committees for Medical and Health Research Ethics) is authorized by the Act on ethics and integrity in research and the Health Research Act, and should pre-approve:

  • Medical and health research projects
  • General research biobanks
  • Exceptions to confidentiality for other types of research

REC makes an assessment as to whether the research is properly conducted, i.e. whether benefits and risks are weighed against each other, and considers whether privacy is assured.

Read more about ethics and research ethics on REC's website.

Applications to REC

A short summary of what you should apply for from REC can be found on our webpage.

Exceptions to confidentiality

Personal health records that are subject to confidentiality can not be disclosed for research unless there is a legal basis (e.g. consent from the person in question) for disclosure. In the absence of legal consent, application for exceptions to confidentiality must be made.  These applications are processed by REC and applications for pre-approval of projects are normally made at the same time.

Research Biobanks

Research biobanks can only be established after they have been approved by REC.

Research biobanks established in connection with collection, storage and use of human biological material as part of a research project,  must be described in the project’s research protocol, and application for approval should be made a the same time as application for pre-approval of the research project is made.

Research biobanks which are established without being associated to a specific research project must also be approved by REC. The same applies to research biobanks which are going to be used for storing and making new use of human biological material, after the original purpose of a research project has been met. When establishing such research biobanks, a separate application for the establishment of the research biobank must be made to REC.

Application for pre-approval of a specific research project must be made to REC when a researcher wants to conduct research on human biological material found in a research biobank that has been established without being associated to a specific project.

Disclosing personal health records to medical and health research from health registries

Application for disclosure of personally identifiable information from central health registries to medical and health research should be sent to the appropriate register. Prior approval from REC must be obtained. The requirement for such approval replaces the earlier requirement of concession from the Norwegian Data Protection Authority or recommendation by a Data Protection Official, the requirement of exception to confidentiality from the Norwegian Directorate of Health, and the requirement of recommendation from REC.

Application for disclosure of non-identifiable personal information from central health registries to medical and health research should also be sent to the appropriate register. The requirement to obtain approval from REC does not apply. The registries can, under specific conditions, forward questions of disclosure of information for REC to decide.

Medical and health research projects which must be submitted to other bodies in addition to REC

Clinical trials of medicines on humans

For clinical trials of drugs on humans the Act relating to medicines applies, while the Health Research Act applies supplementary when appropriate. This means among other things that an application for clinical trials on humans should be sent to the Norwegian Medicines Agency in addition to an application for pre-approval from REC.

Clinical trials of medical devices

Legislation concerning medical devices governs clinical trials of medical devices. The Health Research Act also applies to medical devices in so far as appropriate. In practice this means that at least 60 days before a trial begins, a notification must be sent to the Norwegian Directorate of Health, which is the regulatory authority, in addition to an application for pre-approval from REC.

Research projects within the scope of the Biotechnology Act

Medical and health research found within the scope of the Biotechnology Act is regulated both by the Health Research Act and the Biotechnology Act.

If the Biotechnology Act is applicable, in addition to REC-approval an application must also be submitted to the Norwegian Directorate of Health. The Biotechnology Act regulates among other things assisted reproduction, research on surplus embryos, prenatal diagnosis, postnatal genetic testing and gene therapy.

The Biotechnology Act is not applicable to research that does not have diagnostic or therapeutic consequences for participants or where information regarding individuals cannot be traced back to them. This means that:

  • all research projects where information is to be returned to the individual, must always be submitted to the Norwegian Directorate of Health
  • a prior assessment should be carried out  as to whether the planned research may have diagnostic or therapeutic consequences for the individual if it is conducted
  • if there is reason to believe that during the research period, knowledge can be generated that can be of diagnostic or therapeutic importance for the individual, the Biotechnology Act applies (approval of genetic testing, consent, genetic counseling, approval of activity, reporting requirements) for the research project
  • if the researcher is of the opinion that the research project will not have any diagnostic or therapeutic consequences for the individual, the Biotechnology Act does not apply, except when the researcher plans to return information to the research subject.

Other bodies

Data Protection Official / NSD (Norwegian Social Science Data Services)

All processing of personal data in public and private sector is regulated by the Personal Data Act. This law ensures citizens’ right of privacy so as to ensure that personal data is treated in accordance with basic privacy rights. In order to help businesses raise internal awareness and knowledge of privacy legislation the authority has built up a system of data protection officials. A data protection official can be employed within an organization or be an external resource person.

NSD is the data protection official for research at UiO and other universities, as well as state university colleges.

OUS (in Norwegian) and AHUS (in Norwegian) have their own data protection officials.

Information about data protection can be found on the Norwegian Data Protection Authority’s website.

The Norwegian Data Protection Authority

Some research projects require concessions from the Norwegian Data Protection Authority. These research projects may be projects that process sensitive personal data and:

  • are extensive (over 5000 people) and last a long time (over 15 years)

and/or

  • are large datasets which are not satisfactorily anonymized or pseudonymised
  • perform dropout analysis not based on consent
  • use data from the pseudonymised personal health data filing systems (IPLOS and the Norwegian Prescription Database)

Read more about research and concessions on the Norwegian Data Protection Authority’s website.

The Norwegian Directorate of Health

The Norwegian Directorate of Health has a fiduciary duty as regards the Biotechnology Act and is authorised to:

  • provide approvals according to the Biotechnology Act
  • provide approvals for assisted conception treatments
  • approve research on embryos,  prenatal diagnosis and genetic testing

Read more about the Biotechnology Act on the Norwegian Directorate of Health’s website (in Norwegian).

Contact us

Published July 22, 2015 10:21 AM - Last modified May 14, 2019 9:41 AM