Legislation and research conduct

The research community regulates itself by adhering to proper research protocol. However, legislation ultimately determines the boundaries of research. In Finland, there are many laws and regulations that may have a bearing on research conduct, and it is up to those in charge of the research project to ensure that these are followed. Finnish national legislation is subject to international legal obligations.

Due to the European Union’s General Data Protection Regulation (GDPR) and the Finnish social welfare and healthcare reform (SOTE), the whole legislative framework for research activity is undergoing major change. This is important to bear in mind.

Here are a few examples of laws governing research:

The Medical Research Act (in Finnish, ‘Laki lääketieteellisestä tutkimuksesta’) is a central piece of legislation for medical research. The act regulates matters such as general requirements for research, the use of human test subjects and clinical trials of medicines, as well as foetal and embryo research.

The Act on the Status and Rights of Patients (in Finnish, 'Laki potilaan asemasta ja oikeuksista’) regulates matters such as the disclosure of research plans and the release of patient records for research purposes.

The Act on the Medical Use of Human Organs and Tissues (in Finnish, ‘Laki ihmisen elimien ja kudoksien lääketieteellisestä käytöstä’) regulates the research conducted during autopsies and procedures concerning changes in use of tissue samples.

The Act on the Protection of Animals Used for Research or Educational Purposes (in Finnish, ‘Laki tieteellisiin tai opetustarkoituksiin käytettävien eläinten suojelusta’) regulates (among other things) general conditions, supervisory authorities and permissions concerning research methods used in animal testing.

The Act on the Openness of Government Activities (the 'transparency law', in Finnish ‘Laki viranomaisten toiminnan julkisuudesta’) regulates the publication of official documents, confidentiality, as well as the disclosure of documents for research purposes.

The Gene Technology Act regulates the contained use and deliberate release of genetically modified organisms. ‘Contained use’ refers predominantly to research conducted in greenhouses and laboratories as well as industrial production. Deliberate release includes both field experiments and the placing of products on the market, including their importation.

The task of implementing the General Data Protection Regulation began on 25 May, 2018, and the regulation will set the standard for the processing of personal information. The new Data Protection Act (in Finnish ‘Tietosuojalaki') repealed the earlier Personal Data Act on 1.1.2019.

Updated 4.2.2019.

This English translation of the original article was prepared by Gabriela Fernandez-Jäntti, Aapo Hanhiniemi, Sara Heinonen, Antti Karila, Saku Kattelus, Heikki Kyllönen, Laura Latvala, Irma-Stiina Lehtonen, Severin Leppälä, Jaarli Niukkanen, Kaisu Pihlainen, Suvi Ruokola, Eeva Savolainen, Anni Vehviläinen and Helmi-Sofia Voipio, under the supervision of John Calton, Lecturer in English, in the Department of Languages at the University of Helsinki.