Requirements to acquire ethical approval
The organisation of ethics committees is based on a regional system, with at least one ethics committee in every healthcare district. Each of the hospital districts operating a university hospital must have at least one ethics committee. The Hospital District of Helsinki and Uusimaa, the largest of the Finnish hospital districts, has currently four ethics committees. In addition, there is the National Committee on Medical Research Ethics (TUKIJA), which is located in the Ministry of Social Affairs and Health (TUKIJA website).
According to the Medical Research Act, all medical research plans must first be approved by an independent ethics committee. In cases of clinical drug trials, TUKIJA shall give its opinion (cf. Article 17 of the Medical Research Act).
Medical research is defined as research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general (cf. Medial Research Act, Section 2.1).
The independent ethics committees must evaluate whether trials have been planned in an ethically acceptable manner so as to not cause unnecessary harm or risks to potential research subjects. Particular emphasis is given to the safety, legal status, and rights of the subjects. An assessment of the scientific rationale, the appropriateness of the information presented to subjects, and the procedure used to seek consent is of particular importance.
Ethics committees are not, however, responsible for granting licenses to carry out trials. The committees only issue opinions which the licensing authorities must take into account (TUKIJA website).
Research that only utilises patient data is not covered by the Medical Research Act. This type of research can be carried out on the basis of permission by the authority that has the patient’s files in its possession. There is additionally no need for consent of the data subjects if this permission is granted (Lehtonen and Halila 2005).
Ethical review in the human sciences
In 2009, the National Advisory Board on Research Ethics (TENK) proposed that universities and research organisations should establish (either internal or in cooperation) ethical review committees if (cf. TENK: Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review):
· The study involves an intervention in the physical integrity of subjects,
· The study deviates from the principle of informed consent (ethical review is not required if the research is based on public documents, registries or archived data),
· The study involves children under the age of 15, and the study is not part of the normal activities of a school or an institution of early childhood education and care, and the data are collected without parental consent and without providing the parents or guardians the opportunity to prevent the child from taking part in the study,
· The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (for example, studies containing violence or pornography),
· The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life,
· The study can signify a security risk to subjects (for example, studies concerning domestic violence)
Nearly all of the research establishments working in this area have committed themselves to complying with these ethical guidelines. Commitment to the ethical guidelines for research in the humanities and social and behavioural sciences is voluntary and includes an obligation to arrange an ethical review in accordance with the principles set forth by the Board (TENK website).
For instance, the University of Tampere (UTA) set up an Ethics Committee of the Tampere region in 2010 intended for postgraduate research, based on the above mentioned features. The purpose is to provide ethical reviews of non-medical research in the human sciences conducted at universities, higher education institutions and research institutes in the region (UTA website).
Finnish Advisory Board on Research Integrity
Medical Research Act
National Committee on Medical Research Ethics
Other relevant research ethics committees:
Advisory Board on Biotechnology (BTNK)
The National Advisory Board on Social Welfare and Health Care Ethics (ETENE)
Finnish Advisory Board on Research Integrity: Ethical review in human sciences [online]. Available at: <http://www.tenk.fi/en> [Accessed 9 September 2014].
Lehtonen, L. and R. Halila, 2005. The General Legal Responsibility of Research Ethics Committees in Finland. In: D. Beyleveld, D. Townend, and J. Wright, ed. 2005. Research Ethics Committees, Data Protection and Medical Research in European Countries. Ashgate. pp. 45-54.
Medical Research Act, 1999 [pdf]. Available at: <http://www.finlex.fi/en/laki/kaannokset/1999/en19990488.pdf> [Accessed 10 September 2014].
National Committee on Medical Research Ethics, 2010: Ethical principles [online]. Available at: <http://www.tukija.fi/en> [Accessed 10 September 2014].
National Advisory Board on Research Ethics, 2009. Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review [pdf]. Available at: <http://www.tenk.fi/sites/tenk.fi/files/ethicalprinciples.pdf> [Accessed 9 September 2014].
University of Tampere: Does my study require an ethical review? [online]. Available at: <http://www.uta.fi/english/research/ethics/review/when_required.html> [Accessed 9 September 2014].
University of Tampere: Ethics committee of the Tampere region [online]. Available at: <http://www.uta.fi/english/research/ethics/review/committee.html> [Accessed 9 September 2014].