Finland - RECs and Medical Research

History

The first RECs were established in Finland shortly after the Declaration of Helsinki was issued in 1964. By the 1980's there were RECs in every university hospital and most large hospitals. These were unofficial however and did not necessarily protect the rights of the research subjects. Since joining the Council of Europe in 1992, there has been new biomedical legislation and the existence of RECs is based on the Medical Research Act 488/1999.

There are 6 national ethics commissions in Finland which have different remits but work closely together. They give opinions on various areas of research although most of them do not give legally binding judgements. The board for gene technology and the sub-committee on Medical Research Ethics give opinions that are necessary for initiation of clinical trials. The REC system is essentially a regional one in that every health care district must have at least 1 ethics committee in its area.

Summary of Finnish RECs - table 1

Type of REC	National Advisory Board on Research Ethics	National Advisory Board for Biotechnology	Board for gene technology	National Advisory board on health care ethics
Where situated?	Ministry of education	Ministry of Social Affairs & Health	Ministry of Social Affairs & Health	Government
Who applies to them?	Acts as expert & educational body	Acts as expert & educational body	Monitors genetically modified organisms	Acts as expert & educational body
Formal/ informal	Formal	Formal	Formal	Formal
National/ regional	National	National	National	National
Laws involved	Medical Research Act 488/1999 Act 295/2004 Decree 1374/1991	Medical Research Act 488/1999 Act 295/2004	Medical Research Act 488/1999 Act 295/2004 Gene Technology Act 377/1995	Medical Research Act 488/1999 Act 295/2004 Act 333/1998 Act 494/1998
Guidance involved	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki
Membership requirements	Chairperson, Vice- chairperson & 8 membersFrom different disciplines & authorities in research ethics	Chairperson, Vice- chairperson & 13 membersMembers represent research communities of various disciplines	Chairperson, Vice- chairperson & 5 members. Members represent interested Ministries	Chairperson, Vice- chairperson & 18 members, 4 of whom are Members of Parliament
Responsible/ accountable to whom	Appointed by Ministry of Education for 3 years	Appointed by Ministry of Social affairs & Health for 3 years	Appointed by the government for 5 years	Appointed by the government for 4 years
Approval or Advisory powers	Advisory	Advisory	Approval	Advisory

Summary of Finnish RECs - table 2

Type of REC	Sub-committee on Medical Research Ethics	Co-operation Group for Lab. Animal science	District ethics committees	Institutional ethics committees
Where situated?	Government	Ministry of education	Hospital Districts	Research Institutes
Who applies to them?	Researchers - multi-centre international drugs trials RECs	Acts as expert & educational body	researchers	researchers
Formal/ informal	Formal	Formal	Formal	Formal
National/ regional	National	National	Regional	Regional
Laws involved	Medical Research Act 488/1999 Act 295/2004 Act 484/1999	Medical Research Act 488/1999 Act 295/2004	Medical Research Act 488/1999 Act 295/2004 Personal Data Act 523/1999	Medical Research Act 488/1999 Personal Data Act 523/1999
Guidance involved	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki	Declaration of Helsinki
Membership requirements	Chairperson, Vice- chairperson & 9 members, representing different fields of medicine, law, bioethics & lay people	Chairperson, Vice- chairperson & 11 members, representing universities, research organisations, industry & governmental authorities.	Chairperson & 6 other membersDisciplines other than medicine must be representedMust have at least 2 lay members	Chairperson & 6 other membersDisciplines other than medicine must be represented. Must have at least 2 lay members
Responsible/ accountable to whom	Sub- committee of Advisory Board	Appointed by Ministry of Education for 3 years	The board of the hospital district	n/a
Approval or Advisory powers	Approval	Advisory	Approval	Approval

Not submitting research or failing to follow review

Doing medical research without an opinion of an ethics committee is unlawful and might be punishable by a fine (article 27, act 488/1999).

Which body, if not the REC itself takes this action, and how do they proceed?

The court system may convict an investigator, hospitals may take disciplinary action, patients themselves may take legal action for damages, and the national authority for medico-legal affairs may revoke or restrict a doctor's licence. This last action may be taken with respect to the Medical Research Act (488/1999), the Health-care Professional Act (559/1994) or the rights of patients (785/1992).

Impact of Directive 2001/20 EC

It will reduce the time allowed for RECs to give an opinion to 60 days.
Act 295/2004 is an implementing provision to the Medical Research Act

Legal action that can be taken against RECs

As above: the court system can take action or patients may appeal for damages under 3 Acts: 488/1999; 559/1994; 785/1992

Links section

See the REC bibliography section for more links and papers, and the Data Protection Page