The supervisor is responsible for the project and must be the project manager for Master's theses. The supervisor must also submit the actual application through REK's application portal.
Submitting an application to REK is time-consuming, both in terms of filling in the application and in terms of the processing time. The student and supervisor must take this into consideration when the topic and method for the project is planned. For many students it may be advantageous to select a thesis that is designed in such a way that a REK assessment is not necessary.
REK has a duty to provide guidance, and we recommend contacting them for a preliminary assessment of whether it is necessary to apply for a permit for the implementation of the project.
If the Master's thesis is part of a project that has already been approved by REK, REK must be contacted to clarify whether the thesis triggers a project amendment requirement, or whether REK requires that a separate application be prepared for the thesis.
An application must generally be submitted to REK if
- the project fulfils scientific requirements and aims to produce new knowledge about health and disease.
- the researcher will use information from central health registers and tie these to other registers that are not subject to specific regulations
- the project will use human biological materials that can be tied to specific persons
- the project will use information and evaluations of health issues that can be tied to specific persons
- the project will use and obtain information from one or more central health register that can be tied to specific persons
An application need generally not be submitted to REK if
- the aim of the project is quality assurance. Quality assurance and evaluation is part of the area of responsibility of the health services, even if the project is conducted using scientific methods and aims to produce knowledge that is to be published. It is a prerequisite that the clinical tests in the project are of the same kinds that are used during ordinary diagnosis and treatment of the illness in question.
- the project consists of technical and methodological development using anonymous biological materials
- the project will only use data from central, regional or local health registers, unless otherwise stated in the register regulations
- the project will only use anonymous information and evaluations of health conditions. Anonymous information means information where names, national identity numbers and other information that can be tied to a specific person have been removed. The register owner is responsible for the removal of such information.
- the main rule is that consent must be obtained in order to conduct research on human biological material and health information. This applies whether the data is collected as part of the project, collected from patient journals, health registers, through observations, biobanks, or from other research projects.
- It is, however, possible to apply to REK for an exemption from the duty of confidentiality or for an exemption from the consent requirement for research on human biological materials or health information that have already been collected.
Application to REK
A REK application must contain a filled-in application form. It is important to be detail oriented when filling in the application, as it is the main document that REK uses in its evaluation of the application.
Additionally, the application must contain a complete protocol/project description, information for project participants and any other tools used in the project. Use REK's template for information letters, but remember that this must be adapted for the project in question. If several groups are involved in the project (e.g. children and guardians), each of these must receive an information letter tailored to the group. See template.