Ethical reviewing is of crucial importance in all scientific research. Examples of permits and statements that grant applicant may be asked to present are listed below (in Finnish). In addition, the applicant is asked to familiarize onself with the guidelines of ethical review regarding medical research and human sciences as as well as to consider the up-to-date laws and regulations regarding one’s research project:
- Ethical review in Finland | Finnish National Board on Research Integrity TENK
- Laws supplementing EU regulations on medical devices come into force – fimea englanti – Fimea
- Hallituksen esitys eduskunnalle lääkinnällisiä laitteita koskevia EU-asetuksia täydentäväksi lainsäädännöksi – Ministry of Social Affairs and Health (stm.fi)
In addition, regarding research as part of a wider project, the use of the material by the applicant must be approved by the project or the wider study group. Please contact the group leader or principal investigator for the issues concerning national law and regulations.
- Interview and survey research
- organization approval
- ethical evaluation (see the guidelines of the Research Ethics Advisory Board, in Finnish)
- Medical research
- statement of the ethics committee
- organization approval
- Pharmaceutical research
- TUKIJA’s prior notification
- statement of the ethics committee
- Fimea’s notification
- research site permit
- Equipment research
- statement of the ethics committee
- Fimea’s notification
- research site permit
- Study of patient samples (samples not in the biobank)
- Samples collected for medical research
– statement of the ethics committee
– research site approval - Samples collected for treatment and disease diagnosis
– patient consent or
– the consent of the legal representative of a minor or disabled person, or
– Fimea’s authorization instead of the patient’s consent, if the conditions are met.
– a statement of the ethics committee, if consent is not possible due to the death of the patient
- Samples collected for medical research
- Biobank research
The government’s proposal for a reform of the Biobank Act is scheduled to be submitted to Parliament in autumn 2021. The applicant is asked to follow the national, supplementary guidelines (in Finnish) - Patient records research from one public social and health care organization (registrar)
- organization approval
- statement of the ethics committee
- Research of data from more than one public social health care organization (registrar)
- The licensing authority is Findata
- The applicant is requested to follow the current guidelines
- Experimental animal research
- project permit / Regional State Administrative Agency, National Project Board