FINLAND

Legislation

Finland's Medical Research Act (488/1999)

Research Ethics Committees

Short description of RECs system

National Committee on Medical Research Ethics (Tukija) is an independent expert and authority on medical research ethics in Finland. Tukija’s primary role is to issue opinions on the ethics of clinical trials on medicinal products. Tukija’s duty is also to evaluate the ethical acceptability of the establishment of the new Finnish biobanks.

A separate administrative review division connected to Tukija is responsible for handling the administrative review of negative decisions (i.e., negative statements) of the regional medical research ethics committees.

There are 6 regional research ethics committees established by the University hospital districts. Under Section 16 of the Medical Research Act, each hospital district operating a university hospital in Finland shall have at least one ethics committee. They are responsible for prior evaluation of all medical research projects except clinical trials on medicinal products.

There are other mostly independent and voluntary based research ethics committees for other fields (humanities, studies on national registers etc.) in universities and research centers. These research ethics committees have their own national network, which is coordinated by the National Advisory Board on Research Ethics (TENK).

Further information on Tukija:
http://www.tukija.fi/en

Law on Clinical Trials (983/2021): https://www.finlex.fi/en/laki/kaannokset/2021/20210983

Medical Research Act (488/1999): http://www.finlex.fi/fi/laki/kaannokset/1999/en19990488.pdf

Further information on TENK and on the ethical evaluation of the non-medical research involving human participants: http://www.tenk.fi/en/

Networking between RECs

Tukija, TENK and regional committees organize seminars and other meetings for ethics committees regularly. There are at least 10 meetings yearly where medical research ethics committees can share information with each other.