Projects Needing REK Approval
In the REK Portal, medical and health-related research is defined as follows:
- “The Health Research Act applies to medical and health-related research conducted on Norwegian territory, or when the research is carried out under the auspices of a research institution established in Norway.
- Research may be conducted on humans, human biological material, or health data. The purpose of the research is decisive, not whether it is conducted by healthcare personnel, on patients, or by using health data.
- Research on humans includes research involving direct contact with research participants through interventions and invasive studies (clinical trials of medicines, surgical procedures), collection of human biological material (blood samples, tissue samples), or collection of health data through direct contact (interviews, observation, questionnaires).
- Research on health data refers to research on confidential information pursuant to the Health Personnel Act Paragraph 21, and other information and assessments related to health conditions or of significance to health conditions that can be linked to individuals.”
Although health research is defined by law, there is often uncertainty about whether a project falls under the Health Research Act and therefore requires REK approval. This is particularly relevant when interpreting whether the research aims to generate new knowledge about health and disease, as outlined in Paragraph 4a.
It is REK that determines whether a health research project falls under the Health Research Act. In such assessments, emphasis is placed on the purpose of the research, the participants’ need for protection, and the potential risks to participants.
Quality Assurance Projects
An application to REK is required if the project aims to generate new knowledge about health and disease. This distinguishes such projects from those with purposes such as quality assurance or health services research. These typically take place within a healthcare institution and do not require REK approval.
To determine whether a project qualifies as quality assurance, you can ask the following three questions:
- Is the purpose of the project to improve the quality of patient care at a local level?
- Does the project involve testing practice against established standards?
- Does the project involve patients in ways that would not otherwise occur as part of clinical practice and quality assurance?
If the answer is yes to the first two questions and no to the third, the project is most likely to be one of quality assurance.
Even though quality projects do not require REK approval, they must be clarified and approved by the relevant body. This is typically a department within the healthcare institution, but may also be handled internally within an institution, or in collaboration with private or other public actors. The institution’s Data Protection Officer must subsequently be informed, in accordance with their preferred procedures—for example, via a “Simplified Web Form”.
For more on the distinction between quality projects and health research, see Paragraph 3.1 of the National Committee for Medical and Health Research Ethics (NEM) guidelines on the scope of the Health Research Act (currently only in Norwegian). You may also refer to Paragraph 3.2 on quality assurance projects in the guidelines for the processing of personal data in student and research projects (Guidelines for managing personal information in student and researcher projects (.pdf).
Please note that no data collection may begin before the necessary approval has been obtained. For most projects, this includes Sikt’s assessment of how personal data will be processed and REK approval. However, you may also need additional approval from collaborating institutions, such as health trusts or municipalities. For more information about what approval you may need, see the “Approvals” section under “Planning” on the left-hand side of this page.
Also note that some research projects may undergo significant changes during the course of the project. In cases where a project initially did not require approval, a project’s character, for example, through substantial changes to sampling, methodology, or objective(s), may change such that the project now requires approval. Likewise, if a project that has been approved undergoes major changes, it may be necessary for the project to be reassessed and approved. See the section on Amendments and Extensions of Research Projects located under the Implementation section of these pages.
Resources
- REK Portal
- Health Research Act, as translated by the University of Oslo
- Helseforskningslovens saklige virkeområde (currently only in Norwegian)