Health Research Projects
Formalisation
Medical and health research must be carried out in a safe manner. In order to ensure that health research projects are organized in a sound way, approvals are required.
External approvals refer to the Regional Committees for Medical and Health Research Ethics (REK) and the Norwegian Medicines Agency (DMP) when it comes to the testing of drugs or medical devices.
Internal approvals refer to the procedures that hospitals have in place for registering research activities, securing legal basis for data processing, and ensuring compliance with internal routines. The approvals required at different hospitals may vary.
The formal steps for project implementation described here are taken from the Research Procedure (in Norwegian) at Oslo University Hospital and apply to:
- Employees with project manager responsibilities. The project manager is a researcher who formally applies for prior approval from REK and has daily responsibility for the study.
- Employees responsible for conducting health research projects at Oslo University Hospital (OUS) where the project has an external project manager from another hospital, for example, in a multicentre study.
- Researchers, with or without formal employment, who are subject to the hospital's supervisory authority, for example, by taking part in an OUS project.
If the project is led by a University of Oslo (UiO) employee but involves patients, health information, or human biological material from OUS patients, the Research Procedure must also be followed.
Department Leadership Endorsement
Before research can commence, the project manager must conduct a feasibility assessment, ensure that the study is endorsed by a research group, and that it is approved by the line manager for research.
Together with the research group and line manager, the researcher must clarify:
- Is the project medically and ethically justifiable? This will largely involve a so-called risk-benefit assessment.
- Are privacy and the rights of research participants adequately safeguarded?
- Is there a need to consider a specific privacy impact assessment?
- Is the project sufficiently organized in terms of professional, financial, and administrative aspects?
If multiple departments at the hospital are involved, the project manager or responsible researcher must ensure that collaborating departments are informed and have approved their contributions to the project.
If the project is a multicentre study, the project manager must ensure that collaborating institutions (research responsible) are informed and that necessary binding agreements are in place.
Electronic Notification Form and Privacy Impact Assessment (DPIA)
Health research projects planned for implementation at OUS must be registered using an electronic notification form. The notification form should also be used for significant changes requiring REK approval.
The following documentation must be uploaded in connection with the completion of the notification form:
- A copy of the REK application with all attachments
- Protocol/project description
- Information and consent forms
- REK approval, if available
As part of completing the electronic notification form, researchers will also be asked to fill out a self-declaration regarding DPIA to clarify whether a specific privacy impact assessment (DPIA) is required for the use of personal data.
For projects that require a privacy impact assessment (DPIA), a specific DPIA template should be completed and uploaded in the notification form along with the mentioned documentation. For assistance, send an email to godkjenning@ous-hf.no.
When preparing information and consent forms, see Agreements and templates.
REK Approval and Lawfulness of Processing
The project manager is responsible for applying for prior approval from REK. All health research projects must, in addition to REK approval, have a clearly defined legal basis for data processing in accordance with GDPR Articles 6 and 9.
Once the project manager has submitted the relevant documentation via the electronic notification form and has received REK approval, they will receive an email indicating the legal basis for the study.
The project cannot commence until the necessary approvals and legal basis for data processing are in place. Clinical trials must also be registered in CTIS (drug trials) or ClinicalTrials.gov and on the hospital's websites/Helsenorge.no before commencement, see OUS procedure for registration of clinical trials (in Norwegian).
Formalisation and Approval of Biobanks
A research biobank must be established if there is an intention to store human biological material for research. The guideline threshold for requiring the establishment of a research biobank is storage beyond 2 months; that is, if the biological material is destroyed immediately after analysis, there is no need to establish a research biobank.
The Regional Committees for Medical and Health Research Ethics (REK) must approve all use of biobank material for research before collection and storage can take place. The establishment of a research biobank must be carried out in accordance with the Health Research Act and in compliance with the institution's procedures and guidelines.
Collaboration Agreements
Research involving collaboration between multiple institutions must be formalised in a separate agreement. This is especially important when the research involves sharing and disclosing research data. Typically, the research-responsible institution with project manager responsibilities handles the drafting of the agreement. Agreement templates are also available under Agreements and templates.
For assistance with agreements and any legal questions, see Law, Ethics, and Privacy.