Ethical review in Finland
The Medical Research Act and Decree (488/1999) regulate medical research involving human beings.
According to the Act, medical research means 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.
The ethics committees of hospital districts are responsible for ethical pre-evaluation of medical research. The National Committee on Medical Research Ethics evaluates the ethical aspects of international multi-centre medicinal trials in cooperation with research ethics committees.
For more information on ethical review in medical research, see the National Committee on Medical Research Ethics.
The Research Act only applies to medical research. For research in the humanities and social and behavioural sciences, the Finnish National Board on Research Integrity TENK has issued a set of recommendations on the ethical principles to be followed as well as a proposal for arranging ethical review in these sectors:
- Ethical principles of research in the humanities and social and behavioural sciences and proposals for ethical review(2009) (pdf)
The ethical principles applying to research that can be counted as belonging to the humanities and social and behavioural science are the research subjects'
- right of self-determination
- prevention of harm
- privacy and data protection
What ethical review means is advance scrutiny and evaluation of a research plan in the light of the ethical practices generally followed in that particular discipline of science, with special emphasis on preventing any harm that the research or its results might cause to the research subject. A review applies only to precisely defined research configurations:
1. The study involves an intervention in the physical integrity of subjects,
2. 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),
3. The subjects are 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,
4. The study exposes research subjects to exceptionally strong stimuli and evaluating possible harm requires special expertise (for example, studies containing violence or pornography),
5. The study may cause long-term mental harm (trauma, depression, sleeplessness) beyond the risks encountered in normal life,
6. The study can signify a security risk to subjects (for example, studies concerning domestic violence).
It can be implemented also if the study’s publication forum, financier or an international cooperation partner requests it.
Ethical questions associated with research in the humanities and social and behavioural sciences relate mainly to the interaction between researcher and research subject, which may involve unpredictable factors. It is always the researcher who bears responsibility for the ethical and moral decisions involved in the research.
The request for ethical review in human sciences is made to the ethical committee of the research organisation in question (NB: not to TENK).
Commitment to the 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 TENK. Nearly all of the third-level institutions and research establishments working in this area in Finland have already committed themselves to complying with the guidelines.
For organisations that have committed themselves to the guidelines, see Finnish page Sitoutuneet organisaatiot